Reported trial results for Pancreatic Cancer
Every Pancreatic Cancer trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
127 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT06528093 · results posted 15 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06528093) enrolled a total of eight people across three treatment groups: two participants received a lower dose of the experimental drug BI 765883 on its own (0.4 mg/kg), three received a higher dose on its own (1.3 mg/kg), and three received the lower dose combined with chemotherapy. None of the participants completed the study — all eight left before it finished. The trial was primarily looking at whether certain side effects, called dose-limiting toxicities (serious unwanted effects severe enough to affect dosing decisions), occurred during the first two treatment cycles, in order to help work out the highest dose that could be given safely. It also tracked how tumours responded to treatment and how the drug moved through the body. The reported data shows that, for the primary measure, no dose-limiting toxicities were recorded in either of the two groups receiving the drug alone. However, all three participants in the group receiving the lower dose combined with chemotherapy experienced a dose-limiting toxicity during the evaluation period. For tumour response, the numbers were very small across all groups. When doctors assessed tumour changes using a standard set of criteria (called RECIST 1.1 — a recognised way of measuring whether tumours shrink, stay stable, or grow), between one and three participants in each group showed some level of response or stable disease, though the exact breakdown varied depending on how response was defined and who was doing the assessment. The reported data for the drug's levels in the blood showed that higher doses were associated with higher concentrations, which is what would generally be expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04492800 · results posted 26 May 2026
According to the results reported on ClinicalTrials.gov, this trial looked at the use of the Paxman Scalp Cooling Device, which is a cap worn during chemotherapy treatment that cools the scalp with the aim of reducing hair loss. Nine people took part in the study, and all nine completed it. The trial was measuring three things: how much hair participants kept during chemotherapy, how comfortable participants found the cooling device, and how distressed participants felt about chemotherapy-related hair loss. The reported data shows that, when it came to hair preservation, 2 out of 9 participants experienced lower-grade hair loss (meaning they lost less than half of their normal hair, which would not be obvious to others at a distance), while 3 out of 9 experienced higher-grade hair loss (meaning they lost 50% or more of their normal hair, which would be noticeable to others). Please note that the reported figures account for only 5 of the 9 participants for this outcome, and results for the remaining participants were not reported in the data provided. For comfort, the reported data shows that 5 participants indicated they were comfortable using the device, while no participants reported being uncomfortable — though again, results for the remaining 4 participants were not reported in the data. For hair-loss distress, participants were scored on a scale of 17 to 68 (where a higher number means more distress); the reported average score was 23, which sits toward the lower end of that scale. It is worth noting that this was a very small study with only 9 participants, and some outcome data was not fully reported, so the numbers above represent a limited snapshot only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01585805 · results posted 19 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT01585805) enrolled 83 people in total across several groups. The trial was studying veliparib — a drug being investigated for cancer — both on its own and combined with two chemotherapy medicines (gemcitabine and cisplatin) in patients with a specific type of cancer. The trial had two main parts: a smaller, non-randomised section to find the right dose of veliparib when given alongside chemotherapy, and a randomised section where participants were assigned to one of three groups — veliparib plus chemotherapy (Arm A, 27 people), chemotherapy alone (Arm B, 23 people), or veliparib alone (Arm C, 16 people). The remaining 17 participants were spread across four smaller lead-in dose-finding groups (3, 3, 6, and 5 people respectively). The reported data shows that for the dose-finding portion, the identified dose of veliparib to take forward was 80 mg twice daily. When looking at how many participants showed a measurable reduction in their cancer (known as a "response" — either tumours shrinking significantly or disappearing altogether), the reported numbers were: in Arm A (veliparib plus chemotherapy), 20 out of 27 people showed a response; in Arm B (chemotherapy alone), 15 out of 23 showed a response; and in Arm C (veliparib alone), 5 out of 16 showed a response. For "progression-free survival" — meaning the reported length of time before the cancer was recorded as worsening — the figures were approximately 10.1 months for Arm A, 9.7 months for Arm B, and 1.7 months for Arm C. The lead-in group overall reported 4.2 months. The reported data also shows that all 83 participants across all groups experienced at least one adverse event (an unwanted or unexpected medical occurrence recorded during the study), though the breakdown of types and severity was not detailed in the submitted summary data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06119217 · results posted 13 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06119217) enrolled 194 people across three groups. Sixty-six participants received TTX-030 combined with two chemotherapy drugs (nab-paclitaxel and gemcitabine); 60 received TTX-030 plus an additional drug called budigalimab alongside the same chemotherapy; and 68 received the chemotherapy drugs alone (the comparison group). The trial was primarily measuring how long participants went without their cancer getting worse — called "progression-free survival" — in a subset of participants selected based on certain biological markers (a "biomarker enriched" group). The reported data shows that, in that biomarker enriched group, the time until cancer worsened or death was 5.5 months for the TTX-030 plus chemotherapy group, 7.3 months for the TTX-030 plus budigalimab plus chemotherapy group, and 5.9 months for the chemotherapy-only group. Looking at all participants (not just the biomarker group), the reported figures were similar: 5.5, 7.3, and 5.7 months respectively. For the proportion of participants whose tumour shrank or disappeared (called the "objective response rate"), the reported data shows 36% in the TTX-030 plus chemotherapy group, 38% in the triple-drug group, and 42% in the chemotherapy-only group. The proportion of participants still alive at 12 months was reported as 48%, 40%, and 46% across the three groups. Regarding unwanted health events that occurred during treatment, 64 out of 66, 59 out of 60, and 63 out of 68 participants in each group respectively were reported to have experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03767582 · results posted 11 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 participants in total across five groups. Two groups took part in a Phase I safety-focused stage (3 people at a lower dose and 6 at a higher dose), and three groups took part in a Phase II stage comparing different combinations of immunotherapy drugs — nivolumab, BMS-813160, and GVAX — given alongside radiation and sometimes surgery for pancreatic cancer. The trial was measuring two main things: how many participants experienced side effects linked to the study drugs, and how many showed a notable increase (more than 80%) in a type of immune cell called CD8+CD137+ T cells moving into their tumours after treatment — which researchers used as a sign of immune activity in the tumour. The reported data shows that drug-related side effects were recorded in all participants across the Phase I groups (3 out of 3 at the lower dose, and 6 out of 6 at the higher dose), and in varying numbers in the Phase II groups (3 out of 5 in Arm A, 5 out of 5 in Arm B, and 2 out of 3 in Arm C). For the immune cell measure, the reported data shows that 2 out of 3 participants in the Phase I lower-dose group, 5 out of 6 in the higher-dose group, 3 out of 5 in Phase II Arm A, and 3 out of 5 in Phase II Arm B showed that increase; figures for Arm C were not reported. For the secondary measures, overall survival (the time from the start of immunotherapy until death) ranged from a median of 8.2 months in the Phase I lower-dose group up to 13.7 months in Phase II Arm C. The time until cancer spread to distant parts of the body (metastasis-free survival) ranged from 1.2 months to 11.3 months across the groups. The time until local cancer progression ranged from 7.4 to 11.3 months where data was reported — figures for two groups were not reported. Finally, the number of participants who went on to have successful surgical removal of their tumour ranged from 1 to 5 people across the five groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03049189 · results posted 6 April 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03049189) enrolled 203 people in the 177Lu-edotreotide PRRT group, 99 people in the everolimus group, and 14 people in a smaller sub-study group. The trial was mainly measuring how long people lived without their tumour growing or spreading — known as "progression-free survival" — comparing two different treatments for a type of tumour. A second thing the trial measured was the "objective response rate," which is simply the proportion of participants whose tumour shrank or disappeared during treatment. The reported data shows that, for the primary measure of progression-free survival, the 177Lu-edotreotide PRRT group had a reported median time (the midpoint figure — half of participants had longer, half had shorter) of 23.9 months without their tumour progressing, compared with 14.1 months in the everolimus group. For the secondary measure of objective response rate, the reported data shows that 21.9% of participants in the 177Lu-edotreotide PRRT group had their tumour shrink or disappear, compared with 4.2% in the everolimus group. For the third measure — overall survival, meaning how long participants lived in total — the data was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02047474 · results posted 6 March 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people, all of whom received a chemotherapy regimen called mFOLFIRINOX. The trial was looking at treatment for a type of cancer, and it followed participants through several stages: pre-surgery chemotherapy, surgery, and post-surgery chemotherapy. Of the 46 who started, 37 completed the pre-surgery treatment, 27 went on to have surgery, 22 began post-surgery chemotherapy, and 19 completed the full treatment journey. The trial's main goal was to measure how many participants went a certain period without their cancer getting worse (known as "progression-free survival"). The reported data shows that 67% of participants met the primary goal of remaining progression-free at the measured time point. For the additional measures, the reported data shows that the median overall survival — meaning the midpoint at which half the participants were still alive — was 37.2 months. The median length of time participants went without their cancer progressing was reported as 16.6 months. The trial also measured what is called the "objective response rate" — the percentage of participants whose cancer showed a measurable reduction in size — and this was reported as 17%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04387071 · results posted 17 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04387071) enrolled just 2 participants, both of whom completed the study. The trial was testing a combination of two investigational drugs — CMP-001 and INCAGN01949 — in people with solid tumours. The main things being measured were the proportion of participants whose cancer showed signs of shrinking or disappearing (called the "disease control rate" and "objective response rate"), assessed using standardised tumour-measuring guidelines from MRI scans. The reported data shows that neither of the 2 participants had their tumours disappear completely, shrink meaningfully, or even remain stable — both were recorded as having progressive disease (meaning their tumours grew or new lesions appeared during the study). The objective response rate was therefore reported as 0 out of 2 participants. For the secondary outcomes, the reported data shows a median progression-free survival (the time until the cancer grew or the person died) of 2.9 months, and a median overall survival (time until death from any cause) of 1.6 months. Both participants experienced at least one adverse event (an unwanted health change recorded during the trial). No numbers were reported for the laboratory measure of immune cell activity (OX40 expression). It is worth noting that with only 2 participants, this was an extremely small trial — likely stopped very early — and the reported numbers reflect only those 2 individuals' experiences. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03377491 · results posted 21 January 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 571 adults with a form of pancreatic cancer that could not be surgically removed (locally advanced). Participants were split into two groups: 285 people received a device called TTFields — which delivers low-intensity electrical fields to the body — alongside standard chemotherapy drugs (gemcitabine and nab-paclitaxel), while 286 people received chemotherapy alone. The trial's main goal was to measure how long people in each group lived overall, and secondary goals included how long before the cancer grew or spread, and quality-of-life measures. The reported data shows that no participants were recorded as having formally "completed" the study, which the data attributes to all participants having exited the study (for example, due to death or discontinuation) before a formal completion milestone was reached. The reported data shows that the median overall survival — meaning the point in time by which half the participants in each group had died — was 16.20 months in the TTFields plus chemotherapy group, compared with 14.16 months in the chemotherapy-only group. For progression-free survival (how long before the cancer showed signs of growing or spreading), the reported figures were 10.61 months versus 9.33 months. When looking only at local progression (cancer growing at the original site without spreading elsewhere), the figures were 12.45 months versus 10.41 months. The one-year survival rate — the percentage of people still alive after one year — was reported as 68.1% in the TTFields group and 60.2% in the chemotherapy-only group. In terms of tumour response, 88 participants in the TTFields group and 73 in the chemotherapy-only group were reported to have had their tumour shrink or disappear. Quality-of-life deterioration-free survival was also measured across several areas, with the TTFields group reporting figures ranging from 7.1 to 14.7 months and the chemotherapy-only group ranging from 5.7 to 10.2 months across those domains. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04844970 · results posted 17 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04844970) was studying whether a drug called anamorelin (taken at 100 mg per day) could affect body weight and appetite-related symptoms in people with pancreatic cancer that could not be cured, who were also receiving first-line chemotherapy. Participants were randomly assigned to receive either anamorelin or a placebo (a dummy treatment with no active ingredient). A total of four people took part — two in the anamorelin group and two in the placebo group. This is a very small number, which suggests the trial did not recruit as many participants as originally planned. The reported data shows that no numerical results were provided for the primary outcome — the percentage change in body weight from the start of the trial to week 25 — or for most of the secondary outcomes, including the appetite symptom questionnaire, fatigue questionnaire, weight gain measure, and tumour response to chemotherapy. For these measures, the data was not reported. The only number available relates to overall survival (how long participants lived): the reported data shows that one participant in the placebo group was recorded under this measure, but no corresponding figure was provided for the anamorelin group, and no further detail about survival time was reported. Because so few people were enrolled and most outcome data was not reported, the submitted results provide very limited information about what was being measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02780648 · results posted 3 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people across two groups: 3 in Cohort A and 33 in Cohort B. The trial was looking at the effects of a specialised type of radiation treatment called stereotactic body radiation therapy (SBRT) on people with a pancreatic condition. The main thing being measured was how many participants experienced serious (grade 3 or higher) side effects affecting the gut or blood during treatment. Secondary measurements included longer-term gut side effects, survival over time, and self-reported pain scores. The reported data shows that, for the primary outcome, the most notable figure was 13.89% of participants experiencing a serious acute gut or blood-related side effect of grade 3 or higher for one particular category, while several other categories recorded 0%, and one further category recorded 2.78%. For longer-term gut side effects (the secondary outcome), all reported categories showed 0% of participants experiencing grade 2 or higher toxicities. The reported data shows that for overall survival and metastasis-free survival at one year, the probability was approximately 0.48 (roughly 48 in 100), while progression-free survival at one year was approximately 0.39 (roughly 39 in 100). It is worth noting that these survival figures were only reported for one of the two cohorts, and the data for the other cohort was not reported. For the pain scale (rated 0–10, where higher means more pain), Cohort A reported average scores of 1.0 before treatment, 2.0 during treatment, and 2.0 after treatment, while Cohort B reported 2.0 before treatment, and 0.0 during and after treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05361668 · results posted 31 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05361668) looked at a medicine called paltusotine and enrolled 36 people in total — 18 in a group starting on a 40 mg daily dose and 18 in a group starting on an 80 mg daily dose. Participants were allowed to have their dose adjusted up or down during the trial to help manage their symptoms. Of the 36 who started, 30 completed the study (17 from the 40 mg group and 13 from the 80 mg group). The main thing the trial was set up to measure was safety — specifically, how many people experienced unwanted health events (called "treatment-emergent adverse events," or TEAEs) while taking the medicine. The reported data shows that in the 40 mg group, 16 out of 18 participants experienced at least one TEAE, and in the 80 mg group, 15 out of 18 did. More serious adverse events were reported in 10 people in the 40 mg group and 9 in the 80 mg group. A small number of participants in each group — 3 in the 40 mg group and 1 in the 80 mg group — had an adverse event that led them to stop taking the medicine. The trial also measured the level of paltusotine in participants' blood (a measure called "trough levels," meaning the amount present just before the next dose). The reported data shows that average blood levels varied by dose: roughly 188–217 ng/mL for the 40 mg dose, 360–473 ng/mL for the 80 mg dose, and up to around 1,240 ng/mL for a 120 mg dose that some participants were titrated to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05169437 · results posted 29 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people with locally advanced or metastatic solid tumour cancers that carried a specific gene mutation called PALB2. The study was testing a drug called niraparib to see how many participants' tumours shrank or disappeared (called the "overall response rate"), how long any such response lasted, and how long participants went without their cancer getting worse (called "progression-free survival"). Of the 22 who started, 16 completed the study and 6 did not. The reported data shows that when an independent central review team assessed the scans, zero out of 22 participants had a measurable tumour response to the treatment. When the treating doctors (investigators) assessed the scans separately, the reported data shows 2 participants had a partial or complete response, 5 had stable disease, and 5 had their disease progress. The duration of any response as assessed by the investigators was listed as "not available" — meaning that figure was not reported in the data. For progression-free survival as assessed by the investigators, the reported median figure (the midpoint value for the group) was 3.3 months, meaning half the participants went longer than this without their disease worsening and half went a shorter time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03184870 · results posted 9 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03184870) enrolled a total of 376 participants across 18 different treatment groups. The trial was studying a drug called BMS-813160 given at different doses, either alone or combined with other cancer medicines, in people with colorectal cancer or pancreatic cancer. The trial was run in two parts — Part 1 focused on finding a suitable dose, and Part 2 tested selected doses further. Because the trial had so many groups with different drug combinations and dose levels, the results were reported separately for each group. The reported data shows that across the groups where numbers were provided, every participant who started the initial treatment phase was recorded as not completing it — the trial's own data notes zero completions in the standard sense, which in this type of trial typically reflects the ongoing nature of cancer treatment rather than dropout. For the primary outcomes, the trial measured how many people in each group experienced any adverse event (an unexpected medical problem during the study), a serious adverse event (one serious enough to cause hospitalisation or be life-threatening), a dose-limiting toxicity (a severe reaction used to judge whether a dose is too high), or an adverse event that led to stopping treatment. The reported data shows that in the earlier, smaller groups (roughly 7–11 people each), between 1 and 11 participants per group experienced adverse events, and between 1 and 7 per group experienced serious adverse events. Dose-limiting toxicities were reported in 2 participants each in two of the pancreatic cancer dose groups, and zero in all other reported groups. Numbers for several of the larger Part 2 groups and some secondary outcomes were not fully reported in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02454140 · results posted 12 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02454140) enrolled 30 people in total across three active groups: 3 participants in Cohort 1, 16 in Cohort 2, and 11 in Cohort 3. Cohorts 4 and 5 had no participants. All 30 people who started the trial completed it. The trial was looking at a type of focused radiation treatment called stereotactic body radiotherapy (SBRT) — a technique that delivers precisely targeted radiation in a small number of sessions — for people with pancreatic cancer. The main thing being measured was the highest dose of radiation (in units called Gray, a standard measure of radiation dose) that could be given across five treatment sessions. The reported data shows that the primary outcome — the maximum tolerated dose — was recorded as 50 Gray. This means that, based on the reported results, 50 Gray delivered over five sessions was the dose level identified through this trial. No secondary outcome measures were included in the submitted results data, so no additional findings are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03033225 · results posted 30 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom received the same treatment — a procedure combining a drug called verteporfin with a light-based technique called photodynamic therapy (PDT), delivered via an ultrasound-guided method into the tumour. The trial was measuring how tumours responded to this approach, specifically by looking at CT scan images taken after the procedure to see whether the tumour showed signs of tissue breakdown (necrosis). The reported data shows that of the 13 people who started the trial, 8 completed it and 5 did not. For the main outcome — tumour response — results were reported for 8 participants. Of those 8, 5 were recorded as having responded and 3 were recorded as not having responded, based on standard imaging criteria used to grade changes in tumour size and appearance. CT scans were taken two days after the procedure, and the trial notes that most participants (87.5%) also had additional CT scans taken for unrelated reasons, which were also reviewed as part of assessing the results. It is worth noting that this was a small trial with only 13 participants, and no comparison group (such as a placebo or different treatment) was included in the data reported. The reported data shows numbers only for those who completed the study, and no further outcome measures beyond tumour response appear to have been submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06024174 · results posted 22 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06024174) was studying a combination of two investigational drugs — BMS-986466 and adagrasib — in people with certain cancers. The section of the trial for which results are available (called "Part 1") was specifically looking at how these two drugs interact with each other when taken together, and was tracking safety-related events during that period. Five participants were enrolled in Part 1; none completed the study, and all five left before finishing. The reported data shows that, of the five participants, four experienced at least one adverse event (an unexpected medical occurrence during the study period). One participant experienced a serious adverse event — meaning a medical event considered significant enough to require hospitalisation or to be otherwise medically important. No participants experienced what the trial defined as a "dose-limiting toxicity" (a specific type of serious reaction used to judge whether a dose level is too high), and no participants died or stopped taking the study drugs because of an adverse event. For the second part of the trial (Part 2), which was intended to measure how many participants' tumours shrank or disappeared in response to treatment, no results data was reported on ClinicalTrials.gov — this information was not available. It is worth noting that because only five people were enrolled and none completed the study, the data from this trial is very limited. The reported figures simply describe what was observed in those five individuals during their time in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05546476 · results posted 29 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05546476) looked at a drug called ponsegromab in people with cancer-related cachexia — a condition where serious illness causes significant weight loss and muscle wasting. The trial was run in two parts (Part A and Part B). In Part A, 187 people were divided into four groups: one group received a placebo (a dummy treatment with no active ingredient), and the other three groups received different doses of ponsegromab (100 mg, 200 mg, or 400 mg). The main thing being measured was how much participants' body weight changed over 12 weeks. A number of secondary measures were also tracked, including physical activity levels, walking speed, and how participants felt about their appetite and weight using a standard questionnaire. The reported data shows that for the primary outcome — change in body weight at 12 weeks — the results were listed as "not available" (NA) for all four groups. This means the specific weight-change figures were not reported in the data submitted to ClinicalTrials.gov. For the secondary measures, the reported data shows mixed results across the groups. On the physical activity questionnaire, the 100 mg group showed a reported change of about +52 minutes per day of non-sedentary activity, while other groups showed smaller or negative changes. For overall physical activity counts, the 400 mg group showed a positive change of about +284 units per day, while the placebo and other dose groups showed negative changes. For walking speed, changes across all groups were very small (less than 0.02 metres per second in either direction). On the appetite and cachexia questionnaire (scored out of 48, where higher is better), the reported changes were: placebo +0.52 points, 100 mg +4.76 points, 200 mg +1.15 points, and 400 mg +4.63 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04659603 · results posted 25 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04659603) enrolled 50 people across three groups: 6 people with metastatic breast cancer (Cohort A), 28 people with metastatic pancreatic cancer on one treatment regimen (Cohort B), and 16 people with metastatic pancreatic cancer on a different regimen (Cohort C). The trial was measuring how tumours responded to a treatment called tusamitamab ravtansine, as well as tracking how long participants went without their disease getting worse, and recording any medical events that occurred during treatment. The reported data shows that when looking at the proportion of participants whose tumours shrank meaningfully (called the objective response rate), the figures varied considerably across groups. In Cohort A (breast cancer), 0% of participants met this measure. In Cohort B (pancreatic cancer, regimen one), 3.6% did. In Cohort C (pancreatic cancer, regimen two), 31.3% did. The reported data also shows that the proportion of participants whose disease either shrank or stayed stable (called disease control rate) was 66.7% in Cohort A, 28.6% in Cohort B, and 75.0% in Cohort C. The median time before disease worsened or death occurred was reported as approximately 3.7 months for Cohort A, 1.9 months for Cohort B, and 4.7 months for Cohort C. Regarding medical events during treatment, all 6 Cohort A participants, all 28 Cohort B participants, and all 16 Cohort C participants experienced at least one treatment-emergent adverse event (an unexpected medical occurrence during or shortly after treatment). Serious adverse events were reported in 0 participants in Cohort A, 16 in Cohort B, and 9 in Cohort C. No dose-limiting toxicities (severe early reactions that would require changing the dose) were reported in Cohort C. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04907851 · results posted 17 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04907851) tested a drug called RXC004 across three groups of people with advanced cancers that could not be surgically removed or had spread to other parts of the body. The first group (Module 1) included 6 people with a specific type of advanced pancreatic cancer carrying a genetic change called RNF43 mutation. The second group (Module 2) included 20 people with advanced biliary tract cancer (cancers of the bile ducts and gallbladder) who received RXC004 on its own. The third group (Module 3) included 19 people with advanced biliary tract cancer who received RXC004 combined with another treatment. The trial was measuring things like how many people's cancer did not grow or spread over time, and whether tumours shrank. The reported data shows the following numbers for the main outcomes being tracked. For Module 1 (pancreatic cancer), the figure for how many people remained free of disease progression at six months was listed as "NA" — meaning this result was not reported. For Module 2 (biliary tract cancer, single drug), that same six-month figure was reported as 6.1%. For Module 3 (biliary tract cancer, combination), the percentage of people whose tumours shrank or disappeared (called the objective response rate) was reported as 0%. As secondary — that is, additional — measurements, the proportion of people in each group whose disease was at least kept stable for six or more weeks (called disease control rate) was reported as 16.7% for Module 1, 25.0% for Module 2, and 31.6% for Module 3. The reported data also shows that the median time before disease progressed or death occurred (called progression-free survival) was approximately 1.4 months across all three groups. For tumour size changes, the reported best average percentage change was an increase of around 41.7% in Module 1, an increase of around 20.1% in Module 2, and an increase of around 30.6% in Module 3 — meaning that on average, tumours were measured as larger rather than smaller over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03948763 · results posted 28 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03948763) enrolled 70 people in total across five groups. Three participants received an experimental treatment called V941 on its own, 15 received V941 combined with another medicine called pembrolizumab as part of an initial dose-testing phase, and a further 52 people were enrolled across three expansion groups focusing on specific cancer types — non-small cell lung cancer (20 people), colorectal cancer (16 people), and pancreatic adenocarcinoma (16 people). The trial was primarily looking at unwanted medical events (called adverse events) that participants experienced, and at a specific type of serious side effect called a dose-limiting toxicity — meaning a side effect severe enough to prevent continuing with the planned dose. The reported data shows that, for dose-limiting toxicities, zero participants in both the V941 alone group and the V941 plus pembrolizumab group experienced this type of serious reaction — results for the expansion cohorts were not reported for this measure. For adverse events overall, all participants across every group experienced at least one adverse event — that is 3 out of 3, 15 out of 15, 20 out of 20, 16 out of 16, and 16 out of 16 in each respective group. The reported data also shows that the number of participants who stopped treatment because of an adverse event was: 0 in the monotherapy group, 1 in the Part 1 combination group, 1 in the lung cancer group, 2 in the colorectal cancer group, and 3 in the pancreatic cancer group. As a secondary measure, the trial also tracked what proportion of participants had their tumours shrink by a meaningful amount (called objective response rate). The reported data shows the following figures: 0% for the V941 alone group, 6.7% for the Part 1 combination group, 5.0% for the lung cancer expansion group, 12.5% for the colorectal cancer expansion group, and 0% for the pancreatic cancer expansion group. The trial also measured changes in a type of immune cell (called KRAS-specific T cells) in participants' blood across treatment cycles; the reported data shows varying numerical readings across groups and time points, but a straightforward summary across all groups was not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00630552 · results posted 17 October 2024
According to the results reported on ClinicalTrials.gov, this trial involved 138 participants in total across five groups. The first, smaller part of the trial (called Phase 1b) tested two different doses of a drug called AMG 655 in 13 people, to look at whether certain serious side effects — known as "dose-limiting toxicities" — occurred. The larger second part (Phase 2) enrolled 125 people across three groups: one receiving AMG 655 (41 people), one receiving a different drug called AMG 479 (42 people), and one receiving a placebo — an inactive substitute (42 people). The main things being measured in Phase 2 were how many participants were still alive at six months, and in Phase 1b, whether serious side effects occurred at each dose level. The reported data shows that in Phase 1b, zero participants in either dose group experienced a dose-limiting toxicity (a pre-defined serious side effect). In Phase 2, the reported six-month survival rates were approximately 59% for the AMG 655 group, 57% for the AMG 479 group, and 50% for the placebo group. For secondary measures, the reported data shows that the median time before the disease progressed (got worse) was 3.9 months for AMG 655, 5.1 months for AMG 479, and 2.1 months for the placebo group. Median overall survival — the midpoint time from the start of the study until death from any cause — was reported as 7.5 months for AMG 655, 8.7 months for AMG 479, and 5.9 months for placebo. The proportion of participants whose tumours showed a measurable reduction (called the objective response rate) was reported as approximately 2.6% for AMG 655, 10.3% for AMG 479, and 2.5% for placebo. Regarding adverse events (unwanted medical occurrences during the trial), the reported data shows these were recorded in all 6 Phase 1b participants on the lower dose, all 7 on the higher dose, and in 41, 39, and 40 participants respectively across the three Phase 2 groups — meaning nearly every participant experienced at least one adverse event, though the data does not break down their nature or severity here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02826486 · results posted 28 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people with advanced pancreatic cancer across two groups. Thirty-seven participants were in Cohort 1, receiving two drugs — BL-8040 and pembrolizumab (an immunotherapy). Forty-three participants were in Cohort 2, receiving those same two drugs plus chemotherapy. The trial was primarily measuring how many participants' tumours shrank or disappeared based on scans, using a standard imaging measurement system called RECIST 1.1. It also tracked how long participants lived overall, how long they lived without their cancer growing, and how many achieved any degree of disease control (meaning their cancer either shrank or stayed stable). The reported data shows that, for the main measure — tumours shrinking or disappearing — 1 out of 37 participants in Cohort 1 met that threshold, compared with 8 out of 43 participants in Cohort 2. For disease control (which includes people whose cancer shrank, disappeared, or stayed stable), the reported numbers were 10 out of 37 in Cohort 1 and 25 out of 43 in Cohort 2. Regarding how long participants lived without their cancer growing, the reported figures were 1.5 months for Cohort 1 and 3.8 months for Cohort 2. The reported overall survival — meaning the time from the start of treatment until death — was 3.3 months for Cohort 1 and 6.6 months for Cohort 2. It should be noted that the data shows zero participants were recorded as having "completed" the study in either group, though the reason for this was not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03586869 · results posted 27 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03586869) tested an experimental treatment called the NANT Pancreatic Cancer Vaccine in people with pancreatic cancer. Three participants were enrolled in the study. None of the three participants completed the trial — all three withdrew or left before it finished, though the reasons for not completing are not detailed in the reported data. The trial was primarily looking at side effects (called adverse events), and also tracking whether tumours shrank and how long participants lived without their disease getting worse. The reported data shows that all three participants experienced treatment-emergent adverse events (that is, unwanted health effects that appeared after starting treatment), and two of the three experienced serious adverse events. For the secondary measures, the reported data shows that zero out of three participants had their tumour shrink or disappear, whether measured by either of the two assessment methods used (RECIST 1.1 and irRC). The reported figure for how long participants went without their disease getting worse (known as progression-free survival) was 1.7 months under both measurement methods. The reported overall survival figure — the time from starting treatment until death from any cause — was 4.6 months. It is important to note that these figures come from only three participants, so they represent a very small group. The reported data does not include a breakdown of the types or severity levels of the individual adverse events in the structured results submitted to ClinicalTrials.gov, so further detail on side effects was not available from this data source. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04704154 · results posted 23 July 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people across six groups, each with a different type of cancer: head and neck squamous cell cancer who had not previously received immunotherapy (30 people), head and neck squamous cell cancer who had previously received immunotherapy (20 people), oesophageal squamous cell cancer (30 people), pancreatic cancer (20 people), biliary tract cancer (45 people), and brain tumours (glioblastoma/anaplastic astrocytoma, 30 people). The trial was measuring how tumours responded to the study treatment across these different cancer types, using standard medical imaging criteria to assess whether tumours shrank, stayed stable, or grew. The reported data shows that the number of participants whose tumours shrank meaningfully (either a complete or partial response) varied across groups: 6 out of 30 in the immunotherapy-naive head and neck group, 1 out of 20 in the previously immunotherapy-treated head and neck group, 15 out of 30 in the oesophageal cancer group, 0 out of 20 in the pancreatic cancer group, 2 out of 45 in the biliary tract cancer group, and 1 out of 30 in the brain tumour group. When looking at disease control — meaning tumours that shrank or simply did not grow — the reported numbers were higher across all groups, ranging from 7 (pancreatic cancer) to 24 (biliary tract cancer) participants. Notably, the reported data shows that zero participants were recorded as having "completed" the study across all groups, though the data does not explain the reason for this. The reported data also shows figures for how long responses and survival lasted, measured in days. Among those whose tumours did respond, the time that response lasted was not reported for the head and neck groups, but was reported as 420 days for oesophageal cancer, 432 days for biliary tract cancer, and 140 days for the brain tumour group. The time from the start of treatment until the disease progressed or death occurred (progression-free survival) ranged from a median of 53 days in the pancreatic cancer group to 259 days in the oesophageal cancer group. Overall survival figures ranged from a median of 245 days in the brain tumour group to 627 days in the oesophageal cancer group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01231347 · results posted 16 July 2024
According to the results reported on ClinicalTrials.gov, this trial involved 800 people with advanced (metastatic) pancreatic cancer. Participants were divided into three groups: one group received a placebo (an inactive substance) plus the chemotherapy drug gemcitabine (322 people), a second group received a medicine called AMG 479 at a lower dose (12 mg/kg) plus gemcitabine (318 people), and a third group received AMG 479 at a higher dose (20 mg/kg) plus gemcitabine (160 people). The trial was measuring overall survival — that is, how long participants lived from the time they joined the study. The reported data shows that the median overall survival — meaning the point at which half of the participants in each group had passed away and half were still alive — was very similar across all three groups. The lower-dose AMG 479 group had a median survival of 7.0 months, the higher-dose AMG 479 group had 7.1 months, and the placebo group had 7.2 months. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures cannot be reported here. It is also worth noting that a large proportion of participants did not complete the study in each group — this is not unusual in trials involving people with advanced cancer, but the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03077685 · results posted 24 June 2024
According to the results reported on ClinicalTrials.gov, this trial tested a drug called NanoPac® (a form of the chemotherapy medicine paclitaxel) injected directly into or around a pancreatic tumour. A total of 54 people took part across three phases. The first phase tested three different concentrations of the drug (6 mg/mL, 10 mg/mL, and 15 mg/mL) in small groups of 3–4 people to assess how the body responded. The second and third phases each used the highest concentration (15 mg/mL) in larger groups of 25 and 19 people respectively. The main thing the trial was set up to measure was how many participants experienced unexpected or unwanted health changes after receiving the treatment — including changes picked up through blood tests, physical checks, and vital signs. The reported data shows that across all five groups, nearly all participants experienced at least one such unwanted health change after treatment — 3 out of 3, 3 out of 3, 4 out of 4, 23 out of 25, and 19 out of 19 people respectively. Serious unwanted events were recorded in 2 participants in the second phase group and none in the other groups. For the secondary measures, the reported data shows that when tumour size was assessed using a standard measurement system (called RECIST 1.1), no participants in any group had a complete disappearance of their tumour. A partial shrinkage of the tumour was recorded in 1 person in the 10 mg/mL group, 2 in the second phase group, and 3 in the third phase group. Blood levels of the drug (paclitaxel) varied across groups and time points as reported. Two blood markers associated with pancreatic cancer — CA19-9 and CEA — were also tracked over time; the reported figures varied between groups and between early and later time points, though some data for certain groups was not reported in the submitted results. Pain scores (on a 0–10 scale, where 0 means no pain) were also recorded at various points, with most groups reporting average scores between 0 and 5.5 at different time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03387098 · results posted 22 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03387098) enrolled 4 participants, all of whom received a treatment called the NANT Pancreatic Cancer Vaccine. The trial was in its early phase (Phase 1b), and its main goal was to track and record any unwanted health events — called adverse events (unexpected or harmful experiences) and serious adverse events (more severe harmful experiences) — that occurred during treatment. These were rated using a standard medical grading system to describe how severe they were. The reported data shows that the primary outcome measure — the number of participants who experienced adverse events or serious adverse events — recorded a count of 4 out of the 4 participants enrolled. No further breakdown of the types, severity levels, or details of those events appears to have been submitted in the structured results data on ClinicalTrials.gov. It is also worth noting that none of the 4 participants were recorded as having completed the study, though the reasons for this were not reported in the structured data provided. No secondary outcome measures were included in the submitted results data, so no additional findings can be described here. The trial was very small, and the reported results are limited in their detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06164691 · results posted 21 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT06164691) set out to study whether different types of lighting — blue light, amber light, or standard ambient white light — had any effect on people undergoing chemotherapy and radiation treatment before surgery (known as neoadjuvant chemoradiation). The trial planned to look at several things, including how well the cancer responded to treatment, sleep quality, pain levels, quality of life, physical functioning, and changes in body weight. Only two participants were enrolled, both assigned to the blue light group, and neither completed the study. No participants were enrolled in the amber light or ambient white light groups. The reported data shows that because so few participants started the trial and none completed it, no outcome measurements were recorded for any of the groups across any of the measures — not for cancer response, sleep, pain, quality of life, functional status, or weight change. All outcome data fields were left empty in the submission to ClinicalTrials.gov, meaning there are simply no numbers to report for any of these measures. It is not possible to draw any conclusions from this trial about the lighting conditions being studied, as the trial did not gather enough data to produce any results. The reasons the trial stopped early or why so few people were enrolled were not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04808362 · results posted 25 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04808362) involved 22 participants, all of whom received the experimental treatment called OMO-103. All 22 participants who started the trial also completed it. The trial was primarily looking at the safety and tolerability of OMO-103 — in other words, it was tracking whether participants experienced certain types of side effects or adverse reactions. It also measured how long the treatment took to be processed and cleared by the body. The reported data shows that, out of the 22 participants: 1 person experienced what is called a dose-limiting toxicity (a side effect serious enough to affect how much of the treatment can safely be given); 18 people experienced infusion-related reactions (reactions that happen during or shortly after the treatment is delivered through a drip); 9 people experienced adverse events (any unwanted health events that occurred during the trial); and 10 people experienced serious adverse events (unwanted health events considered more severe). For the secondary outcome, the reported data shows that the average time for OMO-103 to be reduced to half its concentration in the body — known as the "elimination half-life" — was 38 hours. It is worth noting that the data as submitted lists four separate measurements for the primary outcome but does not clearly label which number corresponds to which specific category of side effect beyond what is described above, so the figures should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03535727 · results posted 8 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03535727) involved 48 people in total across two phases. Participants were divided into smaller groups and given different combinations and doses of up to five chemotherapy drugs — gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan. The first part of the trial (Phase 1) was designed to find the highest dose of each drug that could be given in combination, tested across two different dosing schedules (Cohort 1 and Cohort 2). The second part (Phase 2) then enrolled participants at those identified doses to gather further information. The reported data shows that, for the Phase 1 dose-finding portion, the highest doses reached in the trial were: gemcitabine at 500 mg/m², nab-paclitaxel at 125 mg/m², capecitabine at 500 mg twice daily, cisplatin at 20 mg/m², and irinotecan at 20 mg/m². These figures represent what the trial identified as the "maximum tolerated dose" — meaning the highest dose level tested within this study. For the combined Phase 1 and Phase 2 group, the reported data shows a progression-free survival of approximately 5.92 months. Progression-free survival is a measure of how long, on average, participants went without their disease worsening or death occurring from the time they received their first dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03340974 · results posted 15 December 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people in total across four groups. Participants received either a drug called GC4419 or a placebo (an inactive substance), combined with one of two doses of a targeted radiation treatment called SBRT (stereotactic body radiotherapy — a precise form of radiation therapy). The trial was looking at two main things: how often serious digestive-system side effects (or death) occurred within 90 days of starting treatment, and how well the tumour responded to treatment based on scans. The reported data shows that when it came to serious digestive-system side effects graded as severe or life-threatening, very few events were recorded across all groups. In the GC4419 plus lower-dose radiation group (18 people), 1 such event was reported; in the GC4419 plus higher-dose radiation group (6 people), 1 event was reported; in the placebo plus lower-dose radiation group (6 people), no events were reported; and in the placebo plus higher-dose radiation group (12 people), 1 event was reported. For tumour response based on scans, the reported data shows that in the GC4419 plus lower-dose radiation group, 12 participants had stable disease or better, 4 had a partial response (tumour shrank), and none had complete disappearance of the tumour. In the GC4419 plus higher-dose radiation group, 3 had stable disease or better and 3 had a partial response. In the placebo plus lower-dose radiation group, 5 had stable disease or better and 1 had a partial response. In the placebo plus higher-dose radiation group, 8 had stable disease or better, 1 had a partial response, and 1 had progressive disease (tumour grew). It is also worth noting that while all 42 participants completed the active treatment period, none were recorded as having completed the longer-term follow-up phase of the study, though the data does not explain why. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02264665 · results posted 13 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02264665) enrolled 144 people in total across several treatment groups. Participants were already receiving one of a number of treatments for their condition at the time they joined the study — including everolimus (35 people), sunitinib (23 people), chemotherapy (52 people), somatostatin analogues (30 people), metabolic radiotherapy (1 person), or treatments that were not fully documented (3 people). The trial was observational, meaning it tracked what was already happening rather than assigning people to a new treatment. The main things being measured were how many participants went two years without their disease getting worse (called progression-free survival), how many were still alive at two years (overall survival), reasons for stopping treatment, and unwanted medical events (called adverse events) that occurred during the study. The reported data shows that when looking at progression-free survival at two years — meaning the percentage of people whose disease had not progressed and who had not died by that point — the figures varied by treatment group: approximately 26.5% for those on everolimus, 19.3% for sunitinib, 36.5% for chemotherapy, and 38.6% for somatostatin analogues. When the groups were combined into just two broad categories, roughly 19.9% of those on targeted therapies (everolimus or sunitinib) and 29.0% of those on other treatments reached the two-year mark without disease progression. For overall survival at two years, the reported figures were approximately 60.2% (everolimus), 68.4% (sunitinib), 69.6% (chemotherapy), and 79.7% (somatostatin analogues). Across the two broad categories, around 63.9% of the targeted therapy group and 71.7% of the other treatments group were reported to be alive at two years. Data for the metabolic radiotherapy group was not reported for these measures, likely due to the very small number of participants (one person) in that group. The reported data also shows that adverse events — unwanted medical occurrences during the study — were recorded across all treatment groups, with serious adverse events (those considered life-threatening, requiring hospitalisation, or leading to death) reported in 31 of 43 people who received everolimus at any point during the study, 24 of 32 for sunitinib, 48 of 63 for chemotherapy, 13 of 48 for somatostatin analogues, 2 of 6 for metabolic radiotherapy, and none of 8 for other treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04565327 · results posted 13 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04565327) was set up to study a specialised type of medical imaging that uses a substance called hyperpolarised carbon-13 pyruvate to look at how tumours process energy. The trial was divided into two groups: Cohort A, which involved a single imaging dose, and Cohort B, which involved multiple doses taken before and after treatment began. The goal was to see whether this imaging approach could detect changes in tumour activity and whether the images were consistent and repeatable. The reported data shows that zero participants were enrolled or completed the study in Cohort A, while seven participants started and all seven completed the study in Cohort B. For the primary outcomes — which included measuring the signal quality of the imaging in Cohort A and comparing tumour metabolism before and after treatment in Cohort B — no numerical results were reported in the data submitted to ClinicalTrials.gov. Similarly, for the secondary outcomes, which looked at the repeatability of the imaging (Cohort A) and at how tumours responded on standard CT scans (Cohort B), no numerical measurements were provided in the submitted data. Because no outcome measurement figures were included in the submitted results, it is not possible to describe what the imaging or response data actually showed beyond the participant numbers. The reported data shows only that seven people took part through Cohort B and that all seven completed the study, but the detailed findings for every outcome measure were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03611556 · results posted 3 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03611556) enrolled a total of 195 people across seven treatment groups. The trial tested different combinations of two investigational medicines — oleclumab and durvalumab — alongside existing chemotherapy regimens (gemcitabine plus nab-paclitaxel, or mFOLFOX) in people with cancer. The study ran in two phases: a dose-escalation phase (25 participants across four groups, testing whether increasing doses were tolerable) and a dose-expansion phase (170 participants across three groups, examining how many people's tumours responded to treatment). No participants were recorded as having "completed" the study in the formal sense — all were listed as "not completed," which the reported data does not explain further. The reported data shows that in the dose-escalation phase, unwanted medical events that emerged during treatment (called treatment-emergent adverse events) were recorded in all participants across the four groups — 7 out of 7, 7 out of 7, 3 out of 3, and 8 out of 8 respectively. Serious versions of these events were reported in 4, 6, 0, and 4 participants in those same groups. A "dose-limiting toxicity" — meaning a side effect severe enough to potentially cap the dose — was reported in 1 out of 8 participants in the highest-dose mFOLFOX group, and in none of the other three groups. Abnormal vital signs, ECG (heart tracing) readings, and laboratory test results that were flagged as treatment-emergent events were also counted and varied across groups, with the reported numbers generally small given the group sizes. For the dose-expansion phase, the primary measure reported was the percentage of participants whose tumours shrank enough to be counted as an "objective response" (either complete disappearance or a meaningful reduction in tumour size, confirmed on a follow-up scan). The reported data shows that 29.0% of participants in the chemotherapy-only group, 21.1% in the oleclumab plus chemotherapy group, and 32.9% in the oleclumab plus durvalumab plus chemotherapy group met this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02775695 · results posted 3 July 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom completed the study with no drop-outs. The trial was looking at whether doxycycline — an antibiotic — had any effect on a specific type of cell called a "metakaryotic cell" found in pancreatic tumours. These cells were examined in tumour tissue that was surgically removed, and researchers counted how many of these cells appeared dead or dying per gram of tissue. The reported data shows that the primary outcome measured was the number of dead or dying metakaryotic cells per gram of resected (surgically removed) pancreatic tissue. The single figure reported for the one group in the trial was 8.9 cells per gram. No secondary outcome measures were included in the submitted results data, so no further numbers are available to describe. It is worth noting that this was a small study with only 12 participants and no comparison group — meaning there was no separate group of people who did not receive doxycycline — so the reported number of 8.9 cells per gram is a single observation without a direct point of comparison provided in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03989115 · results posted 26 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03989115) enrolled 113 people across eight different treatment groups. Each group received a different combination and dose of two or three investigational medicines: RMC-4630 (paired either with cobimetinib or with osimertinib). The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) while on treatment, and how many experienced particularly serious unwanted events during the first treatment cycle (called dose-limiting toxicities). Secondary measures looked at how the drugs moved through the body — specifically how high drug levels peaked in the blood, how quickly that peak was reached, and how much drug was present over time. The reported data shows that across all eight groups, virtually every participant experienced at least one adverse event: the numbers ranged from 4 out of 4 participants in the smaller groups up to 64 out of 65 in the largest group. Regarding dose-limiting toxicities in the first cycle, the reported data shows: 1 participant in the combined "RMC-4630 daily cobimetinib" grouping; 0 in the intermittent cobimetinib grouping; 3 in the 140mg RMC-4630 plus cobimetinib 20mg daily group; 1 in another cobimetinib 20mg daily group; 0 in the cobimetinib 40mg intermittent group; 2 in the cobimetinib 60mg intermittent group; 1 in the 100mg RMC-4630 plus osimertinib group; and 2 in the 140mg RMC-4630 plus osimertinib group. For the blood-level measurements, peak drug concentrations (the highest level reached in the blood) ranged from 207 to 504 nanograms per millilitre across groups and drugs, and were typically reached within roughly 1 to 3 hours of dosing. The overall drug exposure over time and the degree to which the drug built up with repeat dosing were also reported, with accumulation ratios close to 1.0–1.4 across groups, meaning drug levels did not increase greatly with repeated doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01774019 · results posted 10 April 2023
According to the results reported on ClinicalTrials.gov, this trial involved 284 people in total — 144 were assigned to receive a metal bile duct stent (the WallFlex™ Biliary RX system) before surgery, and 140 received no drainage procedure before surgery. The trial was designed to compare what happened to people in each group across a range of serious health events occurring in the lead-up to surgery, during surgery, and in the weeks after — tracked for up to about five months from when each person joined the trial. The reported data shows that when it came to the main thing being measured — the number of participants who experienced serious adverse events (unexpected or harmful health events considered significant enough to flag) — 40 out of 144 people in the stent group had at least one such event, compared with 36 out of 140 in the no-drainage group. For the additional measures, the reported data shows that stent placement was recorded as successful in 140 out of 144 participants in the stent group. The number of people who needed further procedures on their bile duct after the start of the trial was 8 in the stent group and 12 in the no-drainage group. Successful surgical removal of the affected tissue was recorded for 103 participants in the stent group and 115 in the no-drainage group. Deaths from any cause within the follow-up period were reported for 11 participants in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02210559 · results posted 2 March 2023
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of three medicines — gemcitabine, nab-paclitaxel, and pamrevlumab — compared to just the first two medicines, in people with a form of pancreatic cancer that had not yet spread but could not be removed by surgery at the time they enrolled. A total of 37 people took part: 24 were in the group receiving all three medicines (Arm A), and 13 were in the group receiving just the two chemotherapy medicines (Arm B). The trial was primarily measuring how many participants experienced medical side effects or serious medical events during treatment, and whether surgery caused complications for those who went on to have an operation. The reported data shows that all 24 participants in Arm A and 12 of the 13 participants in Arm B experienced at least one treatment-emergent adverse event (that is, a new or worsening medical problem that occurred during the treatment period). Serious adverse events — meaning more severe medical events such as hospitalisation or life-threatening situations — were reported in 9 participants in Arm A and 6 in Arm B. No surgical complications were reported in either group among those who went on to have surgery. For the secondary outcomes (additional things the trial was tracking), 17 participants in Arm A and 2 in Arm B were reported to have become eligible for surgery after treatment. Of those who had surgery, 4 participants in Arm A and 1 in Arm B achieved what is called an "R0 resection" (meaning no cancer cells were detected at the edges of the removed tissue). When looking at tumour response on scans — meaning the tumour either disappeared completely or shrank by at least 30% — this was reported in 5 participants in Arm A and 3 in Arm B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02551991 · results posted 10 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02551991) enrolled 56 people in total across five groups, which were each testing different doses of the study treatment. The first part of the trial (involving 31 participants across four dose-exploring groups) was looking at how many people experienced what are called "dose-limiting toxicities" — that is, serious side effects severe enough within the first treatment cycle that they may set an upper limit on how much of the treatment can be given. A further 25 participants joined an expansion group at one of the doses. No participants were recorded as having formally "completed" the study; all were listed as "not completed," though the data does not explain the reasons for this in detail. The reported data shows that in the four dose-exploring groups, the number of people who experienced dose-limiting toxicities was: 2 out of 7 in the highest-dose group, 1 out of 7 in the next group, 2 out of 10 in another group, and 0 out of 7 in the lowest-dose group. For the secondary measures, the reported median time before disease progression or death (progression-free survival) ranged from 3.8 months in the lowest-dose group up to 32.3 months in one of the mid-dose groups, with most groups sitting around 9.2 months. The reported median overall survival — the midpoint of how long participants lived from the start of treatment — ranged from 5.8 months to 16.6 months across groups. The proportion of participants whose tumours showed at least some shrinkage (overall response rate) ranged from 0% to 42.9% across the dose-exploring groups, and was reported as 32.0% in the expansion group. The proportion of participants whose disease did not worsen (disease control rate) ranged from 28.6% to 72.0% across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01523808 · results posted 15 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01523808) tested a treatment called GRASPA — a form of an enzyme called L-asparaginase enclosed in red blood cells — in people with a type of blood cancer called acute lymphoblastic leukaemia. Twelve people took part in total, split into four groups of three, each receiving a different dose of GRASPA (labelled 25, 50, 100, and 150). The trial was primarily looking at whether certain serious unwanted reactions — called dose-limiting toxicities — occurred within the first four weeks after treatment. The reported data shows that none of the 12 participants across any of the four dose groups experienced these pre-defined serious unwanted reactions in the first four weeks. The same result was reported for a similar measure tracked from week four through to week eight — again, zero participants in any group were recorded as having these reactions. The trial also measured how the treatment moved through the body (called pharmacokinetics). For the lowest and highest dose groups, the reported data shows the treatment appeared to remain in the body for roughly 19 to 23 days on average. Additionally, the trial tracked levels of a substance called asparagine in the blood — the treatment is designed to reduce these levels. The reported figures show asparagine levels dropped by around 72% to 98% from the starting point across the different dose groups at various time points, though it should be noted that pharmacokinetic data was only reported for two of the four groups, and no data was reported for the other two groups for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02562716 · results posted 23 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in one treatment group (receiving a chemotherapy regimen called mFOLFIRINOX, then surgery, then more mFOLFIRINOX) and 47 people in a second group (receiving a different chemotherapy regimen called Gem/Nab-P, then surgery, then more Gem/Nab-P). The trial was measuring how long people lived overall, how many went on to have surgery, how many had their tumour fully removed during surgery, and how the tumour responded to chemotherapy both before and after surgery. The reported data shows that the median overall survival — that is, the midpoint length of time from joining the trial until death — was 23.2 months in the mFOLFIRINOX group and 23.6 months in the Gem/Nab-P group. Of those who started treatment, 40 out of 55 people in the mFOLFIRINOX group and 33 out of 47 in the Gem/Nab-P group went on to have surgery. Of those who had surgery, 34 (mFOLFIRINOX group) and 28 (Gem/Nab-P group) had what is called an R0 resection, meaning surgeons reported removing all visible tumour with no cancer cells detected at the edges of the removed tissue under a microscope. Looking at tumour shrinkage before surgery based on scans, 5 people in the mFOLFIRINOX group and 10 in the Gem/Nab-P group showed a measurable response. When the removed tumour tissue was examined after surgery, 1 person in the mFOLFIRINOX group and 3 in the Gem/Nab-P group showed a complete response (no remaining tumour cells found); moderate responses were seen in 9 and 10 people respectively; minimal responses in 12 and 10; and poor or no response in 18 and 10. The reported data also recorded serious side effects (Grade 3 to 5) that were considered possibly, probably, or definitely linked to the chemotherapy — the individual numbers for different types of side effects were reported across both groups, with small numbers of participants affected in each category. The full breakdown of those side effect categories was not provided with clear labels in the submitted data, so a detailed description of each cannot be given here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03098550 · results posted 23 July 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — nivolumab and daratumumab — across three groups of cancer patients: those with triple-negative breast cancer (TNBC, 41 people), non-small cell lung cancer (NSCLC, 21 people), and pancreatic cancer (PAC, 43 people). That is 105 participants in total. The main things the trial was set up to measure were unwanted medical events (called adverse events) that participants experienced while on the treatment combination, including serious ones and specific changes in liver and thyroid blood test results. The reported data shows that adverse events of any kind were recorded in all 41 TNBC participants, all 21 NSCLC participants, and 42 of the 43 pancreatic cancer participants. Serious adverse events were reported in 29 of the TNBC group, 14 of the NSCLC group, and 29 of the pancreatic cancer group. Regarding liver blood tests, abnormal results at the most commonly monitored level were seen in 6, 2, and 10 participants across the three groups respectively, with smaller numbers showing more pronounced abnormalities. For thyroid blood tests, a smaller number of participants in each group — ranging from 2 to 4 people depending on the specific measure and group — showed abnormal results. The trial also measured how many participants' tumours shrank (called objective response rate). The reported data shows this was 4.9% in the TNBC group, 9.5% in the NSCLC group, and 0% in the pancreatic cancer group. For those who did have a response, the reported data shows the response lasted a median (middle value) of about 4.2 months in the TNBC group and 9.4 months in the NSCLC group; no duration figure was reported for the pancreatic cancer group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02955069 · results posted 12 April 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 116 people in total across two groups: 95 participants who had a type of tumour called a well-differentiated neuroendocrine tumour (NET), and 21 participants who had a related but more aggressive tumour type called a poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC). The trial was measuring how tumours responded to the study treatment, using standardised imaging-based criteria to track any shrinkage, stabilisation, or growth of tumours over time. The reported data shows that the primary measure — the proportion of participants whose tumours shrank by a meaningful amount (called the overall response rate) — was 7.4% in the NET group and 4.8% in the GEP-NEC group. For secondary measures, the proportion of participants whose disease either shrank or remained stable (called disease control rate) was 64.2% in the NET group and 19.0% in the GEP-NEC group. Among those who did show a tumour response, the reported data shows that responses lasted a median of 250 days in the NET group and 270 days in the GEP-NEC group. The time from starting treatment until a response was first recorded was reported as 110 days for the NET group and 53 days for the GEP-NEC group. The median time before the disease progressed or participants died from any cause (progression-free survival) was reported as 3.8 months for the NET group and 1.8 months for the GEP-NEC group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02704156 · results posted 16 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people in total — 85 in each of two groups. One group received a targeted radiation treatment called SBRT combined with a chemotherapy drug called gemcitabine, while the other group received the same radiation treatment combined with two other medicines, pembrolizumab and trametinib. All 170 participants were recorded as having completed the study. The trial was primarily measuring how long participants lived from the start of treatment, and also tracked a range of other things including how long it was before the disease got worse, how many people were still alive at one and two years, side effects, and quality of life. The reported data shows that the median time from the start of treatment until death — meaning the point at which half the participants had died and half were still alive — was 12.8 months in the gemcitabine group and 14.9 months in the pembrolizumab and trametinib group. For the secondary outcomes, the reported data shows that at the one-year mark, 48 participants in the gemcitabine group and 53 in the pembrolizumab and trametinib group were still alive; at two years, the numbers were 0 and 2 respectively. Regarding how long it was before the disease progressed, the reported median was 5.4 months for the gemcitabine group and 8.2 months for the other group. At one year, 7 participants in the gemcitabine group and 18 in the pembrolizumab and trametinib group were recorded as having no disease progression; at two years, neither group had any participants in that category. Quality of life was measured using a standardised questionnaire scored from 0 to 100, and the reported scores across the measured areas were broadly similar between the two groups, ranging roughly from the low 70s to the mid-80s. The reported data also includes information on treatment-related side effects, which were recorded using a standard medical grading system, though the specific categories for those numbers were not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02921737 · results posted 4 February 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02921737) enrolled 7 participants, all of whom completed the study — none dropped out. There was a single treatment group, and the trial was measuring how long participants went without their disease getting worse (called progression-free survival), as well as several other measures including whether tumours shrank, how long until the disease progressed, and how long participants lived overall. The reported data shows that the average progression-free survival — the time from joining the study until the disease worsened, death, or last contact — was approximately 13.64 weeks. The reported average time specifically until the disease progressed (time to progression) was around 15.43 weeks, and the reported average overall survival — time from joining the study until death — was approximately 23.45 weeks. For the measure called objective response rate, which tracked how many participants had their tumours shrink by at least 30% or disappear entirely, the reported number was zero out of the 7 participants. For clinical benefit rate — which also counted participants whose disease stayed stable (neither growing enough to count as worse nor shrinking enough to count as a response) — the reported data shows 1 out of 7 participants met that definition. It is worth noting that with only 7 participants, this was a very small trial, and the reported figures represent a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02651987 · results posted 30 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people across two groups: 48 with pancreatic neuroendocrine tumours (panNET) and 51 with midgut neuroendocrine tumours (midgut NET). The trial was measuring how long participants went without their disease progressing (getting worse) while receiving a medicine called lanreotide Autogel® 120 mg, given by injection every 14 days. Tumour changes were checked every 12 weeks using CT or MRI scans. Of those who started, 43 in the panNET group and 46 in the midgut NET group completed the study. The reported data shows that the median time without disease progression (meaning half of participants reached this point or beyond before progression or death) was 5.6 months for the panNET group and 8.3 months for the midgut NET group. For the secondary measure of time specifically to progression (not counting deaths), the figures were 5.6 months and 8.7 months respectively. Looking at the proportion of participants still alive and progression-free over time, the reported data shows this declined gradually in both groups across the follow-up period. For overall survival, the median could not be calculated for either group, meaning the data was not mature enough at the time of reporting to produce that figure. No participant in either group showed a complete or partial tumour shrinkage response (objective response rate of 0%) at most time points, though small percentages in the midgut NET group were reported at later time points. The reported data shows that the proportion of participants whose disease was controlled (tumours shrinking or staying stable) was 43.8% in the panNET group and 58.8% in the midgut NET group at week 24, dropping to 22.9% and 33.3% respectively by week 48. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01525082 · results posted 30 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people with pancreatic neuroendocrine tumours that had either spread to other parts of the body or could not be surgically removed. All participants received a combination of three medicines: bevacizumab, capecitabine, and temozolomide. Nineteen of the 20 participants completed the study. The trial was primarily measuring how tumours responded to this treatment combination by looking at changes in tumour size on scans, using a standard set of rules called RECIST. It also tracked how long participants went without their disease getting worse, how long they survived overall, and what treatment-related side-effect events were recorded. The reported data shows that, of the 20 participants, 9 had a partial response — meaning their tumours shrank by at least 30% on scans — and none had a complete disappearance of their tumours. This means 9 participants in total were counted as having an overall tumour response. One participant was recorded as having progressive disease, where tumours grew or new ones appeared. For how long participants went without their disease worsening, the reported average (mean) was 25.2 months. The reported middle value (median) for overall survival — the time from joining the trial to death from any cause or the last known time alive — was 49.8 months. Regarding treatment-related side-effect events, the data reported shows small numbers across different body systems, though the breakdown across individual medicines and organ categories is limited in detail within the submitted results. The reported data also shows that tumour samples from some participants were tested for a particular genetic marker (called MGMT) that researchers thought might be linked to how well temozolomide works. Results were available for a subset of participants across two different testing methods, with varying numbers showing the marker present or absent across different response categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00003531 · results posted 17 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT00003531) enrolled 15 participants, all of whom received a treatment called Antineoplaston Therapy. The trial was measuring how participants' tumours responded to the treatment — specifically, whether tumours disappeared completely, shrank significantly, or remained stable in size over time. Of the 15 people who started the trial, 5 completed it, while 10 did not complete it (the reasons were not reported in the data provided). The reported data shows that the primary outcome looked at two things: "objective response" (meaning the tumour either disappeared completely or shrank by more than half) and "stable disease" (meaning the tumour did not grow or shrink significantly for at least 12 months). According to the results reported on ClinicalTrials.gov, 1 participant was recorded as having an objective response, and 4 participants were recorded as having stable disease. No further breakdown — such as how many had a complete versus partial response — was reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02332863 · results posted 9 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in total — 22 in each group. All 44 participants completed the study with no drop-outs. The trial was comparing two different needle types used to place small marker clips (called fiducial markers) inside a pancreatic tumour: a "back-loaded needle," where the markers are prepared by the medical team before the procedure, and a "preloaded needle," which comes ready to use. The markers are placed using an internal camera procedure (endoscopic ultrasound, or EUS) and are used to help guide radiation treatment. The main thing being measured was how long it took to place the markers. The reported data shows that the time taken just for placing the fiducial markers was 16 minutes on average for the back-loaded needle group and 9 minutes for the preloaded needle group. When looking at the total procedure time from start to finish, the reported figures were 27 minutes for the back-loaded group and 25 minutes for the preloaded group. For a secondary measure of "technical success" — defined as correctly placing three markers in two different positions within the tumour — the reported data shows this was achieved in 22 out of 22 participants in the back-loaded group and 20 out of 22 in the preloaded group. The needle could be clearly seen on the internal camera in 16 of 22 participants (back-loaded) and 14 of 22 (preloaded). The markers could be seen on a CT scan at follow-up radiation appointments in 20 of 22 (back-loaded) and 19 of 22 (preloaded) participants. Accidental early release of a marker was recorded for 1 participant in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02031536 · results posted 2 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02031536) compared two groups: one receiving a drug called everolimus (Arm A) and one receiving a placebo — an inactive dummy treatment (Arm B). The trial was measuring two things: how long participants went without their disease coming back (called "disease-free survival"), and how long participants lived overall ("overall survival"). However, the reported data shows that only 2 people were enrolled in the everolimus arm and no one was enrolled in the placebo arm, meaning the trial was extremely small and appears to have closed well short of its intended size. The reported data shows that, for the everolimus arm, the reported disease-free survival figure was 1.3 years — meaning the time from the start of the study until disease recurrence or death was recorded as 1.3 years for that group. The reported overall survival figure for the same arm was 2.05 years. No figures were reported for the placebo arm, as no participants were enrolled in that group. Because only 2 people participated in the active treatment arm and 1 did not complete the study, these numbers are based on an extremely small number of people and no comparison between the two arms was possible. It is also worth noting that with only 2 participants in total, the reported numbers cannot be used to draw any meaningful conclusions about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02923921 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02923921) enrolled 567 people in total — 283 in the group receiving pegilodecakin combined with a chemotherapy regimen called FOLFOX, and 284 in the group receiving FOLFOX alone. The trial was measuring how long participants lived overall, how long it took for their disease to worsen, and whether their tumours shrank or stabilised. The reported data shows that for overall survival — the time from joining the trial until death from any cause — the median figure (the midpoint where half the participants had died and half had not) was 5.78 months in the combination group and 6.28 months in the FOLFOX-only group. For progression-free survival — the time until the disease was recorded as getting worse or until death — the reported median was 2.14 months in the combination group and 2.10 months in the FOLFOX-only group. When it came to tumour response, 4.6% of participants in the combination group and 5.6% in the FOLFOX-only group showed a measurable shrinkage in their tumours. The percentage of participants whose disease either shrank or remained stable (called the disease control rate) was reported as 42.8% in the combination group and 36.6% in the FOLFOX-only group. Among those who did respond, the response lasted a reported median of 4.99 months in the combination group and 5.17 months in the FOLFOX-only group. Finally, 14.7% of participants in the combination group and 19.1% in the FOLFOX-only group were reported to be alive at 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02324543 · results posted 14 September 2020
According to the results reported on ClinicalTrials.gov, this trial involved 47 people in total and was carried out in two stages. The first stage (Phase 1) included 23 participants spread across five different dosing groups, and was designed to find the highest doses of four chemotherapy medicines — gemcitabine, docetaxel, capecitabine, cisplatin, and irinotecan — that could be given together without causing unacceptable side effects. This upper dose limit is called the "maximum tolerated dose." The second stage (Phase 2) enrolled 24 participants and looked at how many people were still alive nine months after starting treatment. The reported data shows that, for the Phase 1 portion, the maximum tolerated doses identified were: gemcitabine at 500 mg/m² (milligrams per square metre of body surface area), docetaxel at 20 mg/m², cisplatin at 20 mg/m², irinotecan at 20 mg/m², and capecitabine at 500 mg taken twice daily. For the Phase 2 portion, the reported data shows that 57% of participants in that group were recorded as still alive at the nine-month mark, based on a standard statistical method used to track survival over time. It is worth noting that all participants across every group were recorded as having completed the study, with none listed as having dropped out. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so further details — such as tumour response rates or longer-term survival figures — were not reported there and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03681951 · results posted 31 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03681951) was studying an investigational medicine called GSK3145095, given either on its own or in combination with other cancer medicines, including pembrolizumab. The trial was designed in multiple parts, with Part 1 testing GSK3145095 alone at five different dose levels (50 mg, 100 mg, 200 mg, 400 mg, and 800 mg, taken twice daily). Parts 2, 3, and 4 were intended to test GSK3145095 in combination with other treatments. The trial was primarily measuring unwanted medical events (called adverse events) that participants experienced, as well as specific severe reactions known as dose-limiting toxicities — meaning side effects serious enough that they might limit how much of the medicine could be given. The reported data shows that only 8 participants were enrolled, all in Part 1 at the lowest dose level of 50 mg twice daily. No participants were recorded as starting in any of the other dose groups or in Parts 2, 3, or 4. Of the 8 participants in Part 1, all 8 experienced at least one adverse event (an unwanted medical occurrence during the study), and 4 experienced a serious adverse event. When those adverse events were grouped by how severe they were, the reported data shows 0 participants had the mildest level (Grade 1), 3 had Grade 2 (moderate), 4 had Grade 3 (severe), 1 had Grade 4 (life-threatening), and 0 had Grade 5 (death-related). The reported data also shows that 0 participants experienced a dose-limiting toxicity in Part 1. No outcome data was reported for Parts 2, 3, or 4. It is worth noting that the very small number of participants — and the fact that data appears to have been collected only at the lowest dose — suggests this trial closed well before it reached its intended size. The reasons for this were not included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02402062 · results posted 27 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 17 participants, and all 17 completed the study. Every participant received a combination of two drugs: TH-302 and sunitinib. The trial was measuring how tumours responded to this combination, how long it took for tumours to grow or spread, how long any response lasted, and how long participants lived overall. The reported data shows that, when looking at tumour response (the primary goal of the trial), 3 out of 17 participants had a measurable shrinkage in their tumour that met the criteria for a confirmed response, while 14 out of 17 did not meet that threshold. For the secondary measurements: the reported median time before tumours showed signs of growing or before a participant died — whichever came first — was around 10.4 months; the median time specifically until tumours showed radiological signs of growing (separate from death) was around 5.3 months; and among those whose tumours did respond, the median length of time that response lasted was reported as approximately 18.5 months. The reported median overall survival — that is, the midpoint time from starting treatment until death from any cause — was approximately 32.3 months. The reported data also includes figures related to adverse events (unwanted side effects or medical occurrences during the trial), with several numerical counts listed, though the breakdown of what each specific number refers to was not fully detailed in the submitted results data. No further interpretation of those safety figures can be provided beyond what was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02704143 · results posted 17 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 participants, all of whom received a combination of CyberKnife (a type of targeted radiation treatment) and S-1 (an oral chemotherapy medicine). Of the 63 who started, 53 completed the trial and 10 did not. The trial was primarily looking at how many participants were still alive one year after starting treatment, and also tracked a number of other measures including how long it took for the disease to progress, how long participants survived overall, side effects from the radiation, and participants' quality of life. The reported data shows that 46 out of 63 participants were alive at the one-year mark. For the secondary measures, the reported median time before the disease progressed (meaning the point by which half the participants had experienced worsening) was 10.1 months, and the reported median overall survival time was 14.4 months. Regarding side effects from the radiation, 9 participants were reported to have experienced short-term (acute) side effects, and 5 participants were reported to have experienced longer-term (late) side effects, both measured using standard rating criteria. Quality of life was measured using a standard questionnaire scored from 0 to 100; the reported data shows a range of scores across different areas of wellbeing (from around 9.5 to 74.6), though the specific details of which score matched which area of life were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02715804 · results posted 14 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02715804) enrolled 492 people with the aim of comparing two treatment approaches for pancreatic cancer. Participants were divided into two groups: 327 people received a combination called PAG (an experimental drug, PEGPH20, plus two chemotherapy medicines, nab-paclitaxel and gemcitabine), and 165 people received AG (a placebo — an inactive substitute — plus the same two chemotherapy medicines). The trial's main goal was to measure overall survival, meaning how long participants lived after being randomly assigned to their group. The reported data shows that the median overall survival — that is, the point in time by which half of each group had died — was 11.2 months in the PAG group and 11.5 months in the AG group. For progression-free survival (the length of time before the disease was recorded as worsening or participants died), both groups recorded the same median figure of 7.1 months. The percentage of participants whose tumours shrank by a defined amount (called the objective response rate) was reported as 47.1% in the PAG group and 36.4% in the AG group. Among those whose tumours did respond, the reported median duration of that response was 6.1 months in the PAG group and 7.4 months in the AG group. Regarding treatment-emergent adverse events (untoward medical occurrences that arose or worsened during treatment), the reported data shows these were recorded in 325 of 325 participants in the PAG group and 156 of 156 participants in the AG group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01803282 · results posted 4 May 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01803282) enrolled a total of 236 participants across two parts. Part A tested a drug referred to as ADX at three different dose levels (200 mg, 600 mg, and 1800 mg) in small groups of 4, 3, and 6 people respectively. Part B was larger and tested ADX — sometimes combined with another drug called BEV — across a range of cancer types and doses, with group sizes ranging from 8 to 46 people. The trial was measuring, as its main focus, how often participants experienced unwanted medical events (called adverse events) and abnormal blood or other laboratory test results during treatment. The reported data shows that in almost every group, 100% of participants experienced at least one treatment-emergent adverse event — meaning an unwanted medical event that occurred during the treatment period. The one exception was the Part A group receiving the 1800 mg dose of ADX, where 83.3% of participants (5 out of 6) experienced such an event. Regarding laboratory abnormalities — that is, test results that worsened by at least one level compared to the participant's starting point — the reported figures varied more widely. The Part A group on the lowest dose (200 mg) had 0% with laboratory abnormalities, while the 600 mg and 1800 mg Part A groups each showed 33.3%. Across the Part B groups, the reported percentages ranged from 80% to 100%. The data as submitted shows that zero participants in any group were recorded as having "completed" the study, though no further explanation for this was reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02184195 · results posted 27 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02184195) enrolled 154 people in total — 92 received olaparib (300 mg twice daily) and 62 received a placebo (an inactive tablet). The trial was looking at olaparib as a "maintenance" treatment, meaning it was given after initial cancer treatment to see whether it delayed the cancer from growing back or spreading. The main thing being measured was "progression-free survival" — that is, how long participants went before their cancer showed signs of growing again or they passed away. A number of secondary measures were also tracked, including how long people lived overall and how long it was before they needed further treatment. The reported data shows that, for the main measure, the olaparib group went a median of 7.4 months before disease progression or death, compared with 3.8 months in the placebo group. (Median means half the participants in each group reached that point sooner, and half took longer.) For overall survival — how long people lived from the start of the trial — the reported figures were 19.0 months for the olaparib group and 19.2 months for the placebo group. The reported data also shows that the time before needing a first new treatment or dying was 9.0 months (olaparib) versus 5.4 months (placebo), and the time before a second new treatment or death was 14.9 months (olaparib) versus 9.6 months (placebo). The time to a second episode of disease progression or death was reported as 16.9 months (olaparib) versus 9.3 months (placebo). It is worth noting that relatively few participants completed the study as planned — 19 out of 92 in the olaparib group and 7 out of 62 in the placebo group — with the majority in both groups not completing the study for various reasons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01964430 · results posted 6 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01964430) enrolled 866 adults in total — 432 in the nab-paclitaxel plus gemcitabine group and 434 in the gemcitabine-alone group. The trial was looking at two cancer treatments given after surgery, comparing a two-drug combination against a single drug. The main thing being measured was how long people remained free of returning cancer (called "disease-free survival"), and secondary measures included how long people lived overall and how many people experienced unwanted side effects during treatment. The reported data shows that, on average, people in the two-drug group went approximately 19.4 months before their cancer returned or they died, compared with 18.8 months in the single-drug group. For overall survival — how long people lived from the start of the trial — the reported figures show a median (the midpoint where half of participants had longer and half shorter survival) of 41.8 months in the two-drug group and 37.7 months in the single-drug group. Regarding side effects, the reported data shows that nearly all participants in both groups experienced at least one treatment-emergent adverse event (an unwanted health change during or shortly after treatment). Serious or life-threatening side effects (graded 3 or 4 on a standard scale) were reported in 176 people in the two-drug group and 96 people in the single-drug group. Some laboratory blood-chemistry abnormalities at the severe or life-threatening level were also reported in small numbers of participants across both groups, though the data for individual measurements was not fully labelled in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02487277 · results posted 2 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02487277) was set up to study two approaches to combination therapy in people with pancreatic cancer. One group was planned to receive combination therapy with a one-week "run-in" period before starting, and a second group was planned to receive combination therapy alone. The trial aimed to measure things like the rate of a complete disappearance of cancer cells in removed tissue (called a pathologic complete response), the occurrence of a specific type of post-surgical complication involving the pancreas, tumour marker levels in the blood, surgical outcomes, and survival over time. The reported data shows that only three participants were enrolled in total — all three in the "combination therapy with a one-week run-in" group — and zero participants were enrolled in the "combination therapy alone" group. All three participants who started the study also completed it. However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the primary or secondary outcome measures. This means that figures for pancreatic complications, complete response rates, tumour marker changes, surgical margins, overall response, or survival were not reported in the data available on the registry. Because the trial enrolled only three participants and no outcome data was submitted, the reported data shows that no conclusions about the study's measures can be drawn from the numbers on record. The reasons for the very low enrolment and the absence of results data were not explained in the submitted information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02517268 · results posted 19 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 77 people in total who had undergone surgery (likely a major abdominal procedure, based on the complications tracked). Participants were split into two groups: 40 people followed a standard 7-day recovery pathway and 37 followed a shorter, accelerated 5-day pathway. The trial's main question was whether more patients in the accelerated group would be discharged from hospital by the fifth day after their operation. Nearly all participants finished the study — 39 out of 40 in the standard group and all 37 in the accelerated group. The reported data shows that, for the main outcome, 28 out of 37 participants in the accelerated 5-day pathway were discharged by day five after surgery, compared with 5 out of 40 in the standard 7-day pathway. For the secondary outcomes, the reported median length of stay (that is, the middle value when all stay lengths are lined up in order) was 6 days for the standard group and 5 days for the accelerated group. Reported inpatient hospital charges averaged approximately US$155,542 for the standard pathway and US$139,735 for the accelerated pathway. The number of participants who were readmitted to hospital after discharge was 4 in the standard group and 3 in the accelerated group. Regarding post-operative complications, the reported data shows 13 participants in the standard group and 5 in the accelerated group experienced at least one complication overall; figures for specific individual complication types were also reported, though some categories recorded zero events in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00089024 · results posted 21 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00089024) enrolled 29 participants, all of whom received the study treatment. The trial was looking at two main things: how many participants went on to have surgical exploration (an operation to assess whether a tumour could be removed) after completing chemotherapy and a combined chemotherapy-and-radiation treatment, and how many participants experienced serious side effects — recorded as "Grade 3–4 toxicity," meaning side effects rated as severe or life-threatening — at different points during the treatment programme. Of the 29 who started, 24 completed the study and 5 did not. The reported data shows that, for surgical exploration, the numbers of participants at various assessment points were 4, 6, and 9 respectively (the data as submitted does not specify which number corresponds to which exact stage, so these figures are listed as reported). Regarding serious side effects, the reported data shows the following participant counts across the different time points measured: 4, 5, 11, 0, 12, 1, 9, and 0. Again, the submission does not provide clear labels matching each number to a specific time point or side-effect category beyond what is described in the general timeframe, so these figures are presented as reported without further interpretation. It is worth noting that because this was a single-group study with no comparison group, all results reflect only the one group of participants who received the treatment. The reported figures describe what was observed and counted during the trial, but do not on their own indicate whether outcomes were better or worse than any alternative. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01821729 · results posted 17 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people with locally advanced pancreatic cancer. All participants received a combination treatment involving a chemotherapy regimen called FOLFIRINOX, a blood pressure medication called losartan, and radiation therapy. The trial was primarily looking at how many participants who had surgery achieved what is called an "R0 resection" — meaning that when the removed tissue was examined under a microscope, no cancer cells could be seen at the edges of the removed tissue. Secondary measures included how long participants went without their disease getting worse, how long they survived overall, how many experienced serious side effects before surgery, and how many had their disease reduce enough to become eligible for surgery. The reported data shows that of the 50 people who started the trial, 45 went on to receive the combined chemotherapy and radiation phase, and 42 then proceeded to attempted surgery. Of those 42 who had surgery, 30 participants achieved the R0 resection outcome that the trial was primarily measuring. For the secondary outcomes, the reported data shows that the median time before the disease progressed (got worse) was 17.5 months, and the median overall survival — meaning the midpoint time from starting treatment to death from any cause — was also reported as 17.5 months. The reported data also shows that 34 participants had their disease reduce to the point where surgery became possible, and 23 treatment-related serious side effects (graded as moderate-to-severe or worse) were recorded before surgery. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02080260 · results posted 19 July 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, all of whom received the study drug regorafenib. There was only one treatment group — everyone received the same drug, so there was no comparison group. The trial was measuring how many participants were still alive and had not seen their disease grow or spread after 16 weeks of treatment. Only 1 of the 20 participants was recorded as having completed the study; the remaining 19 did not complete it, though the reasons were not broken down further in the reported data. The reported data shows that 2 out of 20 participants were alive and free from disease progression (meaning their disease had not grown or spread) at the 16-week mark, which was the trial's main question. For the additional measures: the middle point for how long participants went without their disease progressing was reported as 6.1 weeks (this is called "progression-free survival" — the time from joining the trial until the disease worsened or the person died). The middle point for overall survival — the time from joining the trial until death from any cause — was reported as 9.4 weeks. In terms of tumour response, 1 out of 20 participants showed a measurable reduction in their tumour size meeting the trial's definition of a response. Six out of 20 participants were recorded as achieving "disease control," meaning their disease either shrank or remained stable rather than growing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02981342 · results posted 25 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 participants across four treatment groups. The groups were: a small safety check group of 7 people receiving abemaciclib (150mg) combined with galunisertib (150mg); 33 people receiving abemaciclib alone (200mg); 33 people receiving abemaciclib (150mg) combined with another medicine called LY3023414 (150mg); and 33 people receiving standard chemotherapy (gemcitabine or capecitabine). The trial was measuring how well each treatment controlled the disease, how long it took before the disease progressed, and how the medicines moved through the body. The reported data shows that for the primary measure of "disease control rate" — meaning the percentage of participants whose cancer did not grow or actually shrank — 15.2% of participants in the abemaciclib-alone group, 12.1% in the abemaciclib-plus-LY3023414 group, and 36.4% in the chemotherapy group met that standard. For "progression-free survival" — meaning the median length of time (in months) before the disease worsened or a participant died — the reported figures were 1.68 months for abemaciclib alone, 1.81 months for abemaciclib plus LY3023414, and 3.25 months for the chemotherapy group. On the secondary measure of objective response rate (participants whose tumours shrank meaningfully), 3% responded in the abemaciclib-alone group, 0% in the abemaciclib-plus-LY3023414 group, and 3% in the chemotherapy group. The reported data also includes some measures of how the medicines were absorbed into the bloodstream (pharmacokinetics), with blood concentration figures provided for the small galunisertib combination group, but the corresponding figures for LY3023414 were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01893801 · results posted 29 May 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 adults who had been diagnosed with a type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma that had not previously been treated. All 25 participants completed the study. The trial tested a combination of three medicines — nab-paclitaxel, cisplatin, and gemcitabine — and was primarily looking at whether any participants achieved a "complete response," meaning their scans and certain blood markers returned to normal levels. It also tracked side effects, changes in a blood marker called CA 19-9, and how long participants lived overall and without their cancer getting worse. The reported data shows that out of the 25 participants, 2 achieved a complete response (where scans and blood markers normalised), 15 had a partial response (some reduction in cancer), 4 had stable disease (no significant change), and 3 had progressive disease (cancer continued to grow). The remaining outcome figures were not broken down further in the submitted data. For the secondary outcomes, the reported data shows an average (median) overall survival — the time from enrolment until death from any cause — of 16.4 months, and an average (median) progression-free survival — the time until the cancer grew or death occurred — of 10.1 months. The CA 19-9 blood marker showed an average change of −47.7% from baseline (starting level). Regarding side effects, the reported data shows 12 participants experienced one category of treatment-related toxicities, 9 experienced another, 1 experienced another, and 3 experienced a further category; however, the specific labels for each toxicity category were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01978184 · results posted 27 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01978184) enrolled 104 people with pancreatic cancer — 43 in one group and 61 in the other. Both groups received a combination of two chemotherapy medicines (gemcitabine and nab-paclitaxel, also known as Abraxane) before surgery, but one group also received an additional medicine called hydroxychloroquine. The main thing the trial was measuring was how much the tumour tissue was destroyed by the time of surgery, scored using a grading system (called Evans grading) that ranges from very little destruction to complete destruction of tumour cells. The reported data shows the following breakdown of tumour destruction scores for participants who went to surgery. In the chemotherapy-only group: 10 people had Grade I (less than 10% of tumour cells destroyed), 17 had Grade II (10–90% destroyed), 3 had Grade III (more than 90% destroyed), and none had Grade IV (no surviving tumour cells found). In the group that also received hydroxychloroquine: 7 people had Grade I, 12 had Grade II, 13 had Grade III, and 9 had Grade IV. The reported data also shows that the average age at diagnosis was about 63.6 years in the chemotherapy-only group and 66.1 years in the combination group, and average tumour size on CT scan was similar in both groups (roughly 2.56 cm and 2.54 cm respectively). The most common surgical procedure in both groups was the Whipple operation (24 and 36 participants respectively). It is worth noting that not all participants who started the trial completed it — 13 people in the first group and 20 in the second did not complete the study, though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00438256 · results posted 23 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total across four groups, each receiving a different dose level of a chemotherapy medicine called capecitabine combined with a type of radiation treatment called proton beam radiation. The trial was looking at treatment for pancreatic cancer. The main goals were to find out how many participants experienced serious side effects (called "dose-limiting toxicities") at the various dose levels, and then to see how the treatment performed in a larger group at the chosen dose. Of the 50 participants, 39 went on to have surgery, and 37 completed the study overall. The reported data shows that in the main safety phase (the largest group of 41 people receiving radiation across five sessions in one week), none of the participants experienced what the trial defined as a serious dose-limiting side effect during the monitoring period. In the follow-on phase involving this same group, 2 out of the participants experienced a grade 3 or higher side effect — a level the researchers described as meaning the treatment was within the threshold they had set for tolerability (they had defined "tolerated" as fewer than 20% of participants reaching that level). For the secondary measures, the reported data shows that none of the participants who had surgery had a complete disappearance of tumour cells in their surgical specimen. The reported median time before disease progressed or death occurred was 10.4 months. None of the participants who underwent surgery experienced a surgical leak complication within 30 days, and none died within 30 days of their operation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01632306 · results posted 19 November 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called LY2090314 given in combination with different chemotherapy regimens to people with cancer. Three treatment groups were planned: LY2090314 combined with gemcitabine (3 participants), LY2090314 combined with FOLFOX (10 participants), and LY2090314 combined with gemcitabine plus nab-paclitaxel (0 participants — this group did not enrol anyone). In total, 13 people started and received at least one dose of the study drugs. The trial's main measurement was a biological marker in tumour tissue and blood that was intended to show whether the drug was having an effect at a cellular level, however no results for this primary measure were reported in the submitted data. The reported data shows the following for the secondary measures. For overall survival — meaning how long participants lived from the time they enrolled — the gemcitabine group had a reported median of 1.8 months, while the FOLFOX group had a reported median of 7.7 months (a "median" simply means the middle value when all results are lined up). For survival at the 6-month mark, 0% of the gemcitabine group were reported as still alive compared with 50% of the FOLFOX group. For progression-free survival — the time before the disease worsened or a participant died — the reported median was 1.8 months in the gemcitabine group and 3.4 months in the FOLFOX group. Finally, when looking at how many participants had their tumours shrink or disappear (called the overall response rate), the reported figure was 0% in the gemcitabine group and 10% in the FOLFOX group. It is worth noting that both groups were very small (3 and 10 people respectively), and the third planned group enrolled nobody at all, which means these numbers should be understood with that context in mind. The primary outcome data — the biological marker measurement — was not reported in the submitted results, so nothing can be drawn from that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02669914 · results posted 10 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02669914) enrolled a total of 4 participants, all of whom were placed in Cohort A (people with a type of lung cancer called non-small cell lung cancer who were not taking corticosteroids). Cohorts B and C — which were intended for people with other solid tumours, or those taking corticosteroids — had no participants enrolled. The trial was studying a treatment called MEDI4736 in people whose cancer had spread to the brain (known as brain metastases), and was looking at how the tumours in the brain and elsewhere in the body responded to the treatment. The reported data shows that, for the primary outcome — how many participants showed a meaningful shrinkage or disappearance of brain tumours — the number reported was 0 out of the 4 participants in Cohort A. For the secondary outcomes: when looking at a broader measure called "disease control" in the brain (which includes tumours that shrank, disappeared, or stayed stable), 2 out of 4 participants met that definition. For tumours outside the brain, 0 out of 4 participants showed a meaningful shrinkage or disappearance, while 1 out of 4 participants achieved disease control outside the brain. When both brain and other body tumours were considered together, 0 out of 4 participants showed a meaningful response. Regarding side effects, the reported data shows that 1 participant experienced each of the listed categories of treatment-related adverse events (unwanted health changes); however, the specific details behind these individual figures are not broken down further in the submitted data. It is worth noting that because only 4 people were enrolled — far fewer than the trial originally planned for — the reported data shows results from a very small number of participants, and no results were reported for Cohorts B or C. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02289898 · results posted 8 August 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02289898) enrolled 204 people across three groups: 68 received placebo followed by placebo, 71 received the experimental drug demcizumab followed by placebo, and 65 received demcizumab followed by demcizumab. The trial was measuring how long participants went without their condition getting worse — a period known as "progression-free survival." Only a relatively small number of participants in each group finished the full study: 16, 18, and 9 respectively, with the majority not completing it (reasons were not detailed in the data provided here). The reported data shows that for the primary outcome, the trial grouped the two demcizumab arms together and compared them to the placebo-only group. In the placebo group, 38 participants were assessed, and the reported figures show smaller numbers at various time points — 5, then 3, with 22 recorded at another measurement point. In the pooled demcizumab group, 70 participants were assessed, with 12, then 7, and 47 recorded at the corresponding points. The data submitted does not include labels clearly explaining what each of these individual numbers represents at each time point, so a full plain-English breakdown of every figure cannot be provided without risk of misrepresentation. It is worth noting that the data as submitted to ClinicalTrials.gov is limited in the detail available here, and no secondary outcome measure results were included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02282722 · results posted 7 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02282722) enrolled 186 patients in total — 94 in the "usual care" group and 92 in the "investigational care" group. The trial was looking at whether a particular approach to care changed how well patients understood their chemotherapy, how involved they felt in decisions about their treatment, and how satisfied they were with communication. By the end of the study, 71 patients in the usual care group and 73 in the investigational care group completed all assessments. The reported data shows the following for the main (primary) outcome — whether patients accurately understood that chemotherapy was unlikely to cure their cancer: 39 participants in each group gave what was defined as an accurate response. For secondary outcomes, when it came to accurately understanding the risks (side effects) of chemotherapy, 47 participants in the usual care group and 33 in the investigational care group were recorded as accurate. Regarding understanding the overall goals of palliative chemotherapy (for example, controlling cancer growth or relieving symptoms rather than curing), 68 in the usual care group and 65 in the investigational care group were recorded as having an accurate understanding. On a scale measuring how conflicted patients felt about their treatment decision (0 = most conflict, 6 = no conflict), the reported averages were 5.2 for the usual care group and 5.5 for the investigational care group. For satisfaction with communication during decision-making (scored 1–4, with 4 being most satisfied), both groups scored similarly, at 3.6 and 3.7 respectively. The number of participants who felt they achieved their preferred role in decision-making was reported as 48 in the usual care group and 39 in the investigational care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01688336 · results posted 21 August 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01688336) enrolled 9 participants, all of whom completed the study. All 9 received a chemotherapy regimen called FOLFIRINOX — a combination of several chemotherapy medicines given together. The trial was designed to look at how long patients with a type of pancreatic cancer that could not be surgically removed (either "unresectable locally advanced" or "borderline resectable") lived after starting treatment, as well as several other measures related to how the cancer responded. The reported data shows that the median overall survival — that is, the midpoint survival time, meaning half of patients lived longer than this and half lived shorter — was 28.5 months for the group with unresectable locally advanced disease. For the smaller group of "borderline resectable" patients, the reported median overall survival was 9.0 months. The trial also measured "progression-free survival" (the time before the cancer grew or patients passed away), which was reported as 10.7 months across the group. When looking at tumour responses, the reported data shows that 11% of patients had their tumours shrink by a meaningful amount (called an "objective response"), while 89% of patients had their disease either shrink or remain stable (called "disease control"). Finally, 22% of patients who started out with cancer considered inoperable were later assessed as being able to undergo surgery. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00634751 · results posted 8 August 2017
According to the results reported on ClinicalTrials.gov, this trial involved 48 people across two phases. In the first (Phase I) part, 9 people received a lower dose of a drug called sorafenib combined with another drug called docetaxel, and 7 people received a higher dose of the same combination — the goal was to assess dosing. In the second (Phase II) part, 24 people with pancreatic cancer and 8 people with biliary tract cancer (cancers of the bile ducts and gallbladder) received the treatment combination. The trial was measuring how many participants' tumours responded to treatment, as well as how long participants went without their disease getting worse (progression-free survival) and how long participants lived overall (overall survival). The reported data shows the following response numbers — noting that the data appears to cover three categories of response (likely complete response, stable disease, and partial response or similar groupings), though the category labels were not included in the available data. For the lower-dose Phase I group (9 people), the numbers across the three categories were 1, 5, and 1. For the higher-dose Phase I group (7 people), the numbers were 1, 2, and 0. For the Phase II pancreatic cancer group (24 people), the numbers were 3, 11, and 6. For the Phase II biliary tract cancer group (8 people), the numbers were 1, 5, and 1. For the two secondary measures — progression-free survival and overall survival — figures were only reported for the pancreatic cancer group. The reported data shows a median progression-free survival of 6.0 months and a median overall survival of 8.1 months for that group. No figures for these two measures were reported for the other groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00920023 · results posted 25 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study. The trial looked at a type of MRI scan that uses tiny magnetic particles (called superparamagnetic iron oxide nanoparticles, or SPIO) injected into the body to help make lymph nodes more visible on the scan. The goal was to measure how well this special MRI could detect cancer that had spread to lymph nodes — including small deposits that might otherwise be missed. The reported data shows two main measurements, both compared against tissue samples examined in a laboratory (used as the benchmark for what was truly positive or negative). The first measurement, called **sensitivity** — meaning how often the scan correctly identified lymph nodes that did contain cancer — was reported as 83.3%. The second measurement, called **specificity** — meaning how often the scan correctly identified lymph nodes that did *not* contain cancer — was reported as 80%. No other outcome figures were included in the submitted data. It is worth noting that this was a small study of only 15 people, and the reported data does not include information on any other outcomes beyond these two figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02117479 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02117479) enrolled 321 people with cancer — 161 who received ruxolitinib combined with capecitabine (a chemotherapy tablet), and 160 who received a placebo (a dummy pill) combined with capecitabine. The main thing the trial was measuring was overall survival — that is, how many participants had died by a set cut-off date. Secondary measures included how long it took for the disease to get worse (progression-free survival), how many participants showed a measurable reduction in their cancer (objective response rate), how long those responses lasted, and how many participants experienced unwanted side effects during treatment. The reported data shows that, by the data cut-off, 113 deaths had occurred in the ruxolitinib group and 124 in the placebo group. For progression-free survival, the median time before the disease worsened or death occurred was reported as 43 days in the ruxolitinib group and 44 days in the placebo group. The percentage of participants whose cancer showed a measurable response (either completely disappearing or shrinking by at least 30%) was 3.7% in the ruxolitinib group and 1.9% in the placebo group. The duration of those responses was not reported in the submitted data. Regarding side effects, 152 participants in each group experienced at least one treatment-emergent adverse event (an unwanted health event that occurred after starting the study drug). Serious adverse events were recorded in 89 participants in the ruxolitinib group and 75 in the placebo group. It is also worth noting that very few participants — only 5 in the ruxolitinib group and 4 in the placebo group — were recorded as having completed the study, with the large majority not completing it, though the reasons for this are not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01128296 · results posted 6 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total across six groups, each receiving a different daily dose of a drug called hydroxychloroquine (HCQ) combined with a fixed dose of a chemotherapy drug called gemcitabine, before surgery. The trial was testing this combination in people with pancreatic cancer that could potentially be removed by surgery. The main thing the trial was set up to measure was whether any dose of HCQ caused what researchers call a "dose-limiting toxicity" — meaning a side effect serious enough to prevent the dose from being used going forward. The trial also tracked how long participants lived overall and how long they lived without their cancer returning. The reported data shows that across all six dose levels of HCQ, zero out of 31 participants experienced a dose-limiting toxicity. For the secondary measures, the reported data shows that among participants in the highest dose group (1,200 mg/day), the middle point — or median — for how long people lived without their disease returning was about 12 months. Looking across all dose groups combined, the median overall survival (how long participants lived in total) was reported as approximately 35 months. The trial also looked at whether a biological marker called LC3-II (a measure of a cell process called autophagy) changed with treatment. Participants whose marker increased by more than 51% had a reported median disease-free survival of about 15 months, compared to about 7 months for those whose marker did not increase by that amount; their median overall survival figures were approximately 35 months versus 11 months respectively. Additionally, the reported data shows that 77% of participants who completed treatment went on to have surgery where surgeons reported no remaining tumour at the margins (known as an R0 resection). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02109445 · results posted 12 June 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02109445) enrolled 3 participants, all of whom received a combination of three medicines: PF-03084014, nab-paclitaxel, and gemcitabine. The trial was designed in two phases — a first phase focused on finding a safe starting dose by looking at serious side effects in the first treatment cycle, and a second phase intended to measure how long participants lived overall. None of the 3 participants completed the study. The reported data shows that in the first phase, 2 out of the 3 participants experienced what the trial defined as a "dose-limiting toxicity" during their first cycle of treatment — meaning they had a significant side effect or a treatment delay of more than two weeks that was considered at least possibly linked to the study medicines. For adverse events (unwanted health changes noticed after starting treatment) in the first phase, all 3 participants were counted across the reported categories. All 3 participants also had at least one laboratory test result flagged as abnormal during the first phase. Because the trial stopped before reaching its second phase, the reported data shows no results for overall survival, Phase 2 adverse events, or Phase 2 laboratory abnormalities — those figures were not reported. The reported data reflects a very small number of participants, and the trial did not progress to its planned second phase, meaning many of its intended measurements were never completed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01303159 · results posted 23 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 29 people who had either cholangiocarcinoma or pancreatic cancer that could not be removed by surgery. All participants received a procedure using a device called the EndoHPB — a small probe inserted via a tube into the body to deliver radiofrequency energy (a type of heat) to a narrowed bile duct (a tube that carries digestive fluid from the liver). The trial was measuring two things: whether the width of the narrowed bile duct changed after the procedure, and how many participants experienced unwanted health events (called adverse events) during the study period. The reported data shows that the average change in bile duct width from the start of the trial to the end was recorded as zero — meaning no measurable change in duct diameter was reported for this group as a whole. Out of the 29 people who started the trial, only 6 were recorded as completing it, while 23 did not complete it; the reasons for this were not detailed in the data provided. The reported data also shows that 16 out of 29 participants experienced at least one adverse event during the study, though the specific nature or severity of those events was not broken down in the data submitted. It is worth noting that these numbers come from a small group of participants and that several data points — such as the reasons participants did not complete the trial — were not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01525550 · results posted 19 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people with cancer who were treated with a medicine called sunitinib. Participants were split into two groups: 61 people who had not previously received treatment for their condition (the "treatment naive" group), and 45 people who had already tried other treatments (the "later-line" group). The trial was primarily measuring how long participants went without their cancer growing or spreading — a period called "progression-free survival" (PFS). The reported data shows that for the primary outcome, the median PFS (meaning the point at which half the participants had experienced tumour progression or death) was 13.2 months in the treatment-naive group and 13.0 months in the later-line group, based on assessments by the treating doctors. When an independent panel of reviewers looked at the same scans, they reported slightly lower figures: 11.1 months and 9.5 months respectively. The reported data also shows that the median time until the tumour first showed signs of growing (without counting deaths) was 14.8 months in the treatment-naive group and 14.5 months in the later-line group. For overall survival (how long participants lived), a median figure was reported for the later-line group at 37.9 months, while the data was not reported for the treatment-naive group. In terms of tumour response, approximately 21.3% of the treatment-naive group and 28.9% of the later-line group were reported to have had their tumours shrink or disappear. Among those who did respond, the reported duration of that response was 19.1 months in the treatment-naive group and 14.7 months in the later-line group. It should be noted that none of the 106 participants were recorded as having formally "completed" the study, which the trial record attributes to all participants falling under the "not completed" category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01844817 · results posted 16 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01844817) enrolled 132 people in total — 66 in each group. Participants were randomly assigned to receive either a drug called OGX-427 or a placebo (an inactive treatment used for comparison). The trial was primarily measuring how long people lived overall, and also tracked how long it took for the disease to get worse, as well as whether tumours shrank during treatment. The reported data shows that, for overall survival — the time from joining the trial until death — the OGX-427 group had a reported median of 5.3 months, compared with 6.9 months in the placebo group. (Median means half the participants lived longer than this time and half did not.) For progression-free survival — the time until the disease was recorded as getting worse or until death — the reported median was 2.7 months in the OGX-427 group and 3.8 months in the placebo group. For the objective response rate — the percentage of participants whose tumours completely disappeared or shrank by at least 30% — the reported data shows 18% in both the OGX-427 group and the placebo group, with 0% recorded for complete disappearance of tumours in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02202785 · results posted 15 May 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called MLN0264 in 43 people with cancer. Participants were divided into three groups based on how much of a particular protein (called GCC) was present in their tumour — low (11 people), intermediate (15 people), and high (17 people). All participants received the same dose of MLN0264. The trial was primarily measuring how many people's tumours shrank or disappeared (known as the "overall response rate"), and none of the participants completed the study as planned — all were recorded as having not completed it. The reported data shows that, for the primary measure of tumour shrinkage or disappearance, the figure was 0% in the low-GCC group, 8% in the intermediate-GCC group, and 0% in the high-GCC group. For a broader measure called "disease control rate" — which also counted people whose tumours stayed stable for at least 12 weeks — the reported figures were 0% (low), 23% (intermediate), and 20% (high). The reported data shows that the median time before the disease got worse (called progression-free survival) was around 39 days for the low-GCC group, 42 days for the intermediate group, and 41 days for the high group. For those who did show a response, the duration of that response was reported as 103 days across the combined group. Regarding lab test findings, the reported data shows that 20 participants had at least one severe or higher abnormal result in blood chemistry, 16 in blood counts, and 23 in a category described as coagulation (blood clotting tests); no participants had notable changes in vital signs such as blood pressure or heart rate. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00733746 · results posted 8 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 119 people, all of whom received the same treatment sequence: chemotherapy before surgery (called "neoadjuvant" therapy), followed by surgery, and then further chemotherapy after surgery ("adjuvant" therapy). The trial was looking at patients with a type of pancreatic cancer that was considered potentially operable. The main thing being measured was how many participants were still alive two years after joining the trial. A number of secondary measurements were also tracked, including how many went on to have surgery, how long it was before the disease came back or got worse, how many participants responded to the pre-surgery chemotherapy, and how many experienced significant side effects. The reported data shows that 54 out of every 100 participants (a proportion of 0.54) were alive at the two-year mark. For the secondary measures, the reported data shows that 76 out of every 100 participants (a proportion of 0.76) went on to have surgery to remove their tumour after the initial chemotherapy. The reported median time before disease came back or got worse was 11.9 months (meaning half of participants reached that point before 11.9 months, and half after). When it came to the tumour visibly shrinking in response to the pre-surgery chemotherapy, the reported data shows a response rate of 0.06, or about 6 in every 100 participants. Regarding significant side effects, the reported data shows that 27 participants experienced side effects graded as level 3 or higher (meaning serious or severe) during the treatment period, with a further 2 participants also recorded in that category — though the data as submitted does not make fully clear what these two separate figures represent. A complete breakdown of all side effects was noted as being available in a separate section of the trial report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01822756 · results posted 13 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people in total, spread across five groups (called cohorts): Cohort A0 (16 people), Cohort B(-1) (4 people), Cohort B0+GCSF (10 people), Cohort B0-GCSF (4 people), and Cohort B1 (8 people). The trial was testing a drug called ruxolitinib (RUX) given alongside chemotherapy (gemcitabine, with or without nab-paclitaxel) in different dose combinations. The main thing being measured was how many participants in each group experienced serious side effects severe enough to be classed as "dose-limiting toxicities" — that is, side effects bad enough during the first treatment cycle to affect how much of the treatment could be given. Almost all participants left the study before completing it; only one person (in Cohort B1) was recorded as completing the trial. The reported data shows that for the primary measure — the percentage of participants who experienced these serious dose-limiting side effects — the figure was 0% in Cohort A0, 0% in Cohort B(-1), 20% in Cohort B0+GCSF, 50% in Cohort B0-GCSF, and 0% in Cohort B1. For a secondary measure looking at how tumours responded (using standard imaging criteria known as RECIST), the percentage of participants recorded as having any response was reported as 12.5% in Cohort A0, 25% in Cohort B(-1), 50% in Cohort B0+GCSF, 25% in Cohort B0-GCSF, and 37.5% in Cohort B1. Several other secondary measures — including drug levels in the blood and changes in biological markers — were listed but no numerical data was reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00947167 · results posted 3 March 2017
According to the results reported on ClinicalTrials.gov, this trial involved a single group of participants who received a combination of two medicines — pertuzumab and erlotinib — for a type of cancer treatment. The trial ran in two stages: first, four people received pertuzumab on its own, and then three of those participants moved on to also receive erlotinib alongside the pertuzumab. All seven participants who started each stage completed it. The trial was primarily looking at how many participants showed a measurable reduction in their cancer (called "response rate"), and it also tracked side effects experienced by participants. The reported data shows that, for the primary outcome — the number of participants whose cancer showed a measurable response to the treatment — the result was zero out of the participants assessed. For the secondary outcome, which looked at side effects (graded using a standard medical scale called CTCAE), the reported data shows that four participants had side effects recorded and assessed. It is worth noting that this was a very small trial with only a handful of participants, so the numbers reported here are limited in scope. Some details, such as the specific types or severity of side effects experienced, were not included in the data reported to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01374451 · results posted 20 December 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people with a type of tumour known as a neuroendocrine tumour. Participants were randomly assigned to one of two groups: 79 people received a combination of two medicines — pasireotide LAR and everolimus — while 81 people received everolimus on its own. The trial's main goal was to measure how long participants went without their disease getting worse (called "progression-free survival"), and it also tracked a number of other outcomes including how many participants' tumours shrank, how long those responses lasted, and how many participants were still alive at various points during the study. The reported data shows that for the primary outcome — time without disease progression — the combination group had a reported median of 16.82 months, compared with 16.59 months for the everolimus-alone group. For the secondary outcome looking at tumour shrinkage (called "objective response rate"), the reported data shows that 20.3% of participants in the combination group had their tumours shrink to a meaningful degree, compared with 6.2% in the everolimus-alone group. Regarding overall survival, the reported data shows the percentage of participants still alive at various time points was broadly similar between the two groups across the follow-up period. The duration of response figures were not reported in a way that could be summarised numerically, and the data for one other secondary outcome (predictive probability of success in a larger trial) was also not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00093782 · results posted 12 December 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 participants, all of whom received the study drug temsirolimus. All 36 participants completed the study. The trial was measuring how tumours responded to the treatment, using a standard set of rules called RECIST criteria, which looks at whether tumours shrink, stay the same, or grow. It also tracked how long participants survived and how stable their disease remained over time. The reported data shows that out of 36 participants, 2 had their tumours shrink enough to count as a measurable response (either a partial or complete response) under the RECIST rules. A further 20 participants were reported to have stable disease — meaning their tumours did not grow significantly — for at least 2 months. For survival, the reported median survival time (the point at which half the participants had passed away and half had not) was 13.9 months. The reported survival rate — described as a percentage of participants still alive at a set point in time — was 71.5%. Additionally, the reported data shows that 213 treatment cycles across all participants were analysed to assess the drug's tolerability, though specific details from that analysis were not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00383760 · results posted 9 December 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study. The trial was testing a drug called eribulin mesylate (also referred to as E7389) and was primarily looking at whether participants' tumours shrank — either completely disappearing or reducing in size by at least 30% — using a standard imaging-based measurement system called RECIST. The reported data shows that for the primary goal — tumour shrinkage meeting those criteria — none of the 15 participants (0 out of 15) recorded a response. For the secondary measures, the reported data shows that 33% of participants had what is called "stable disease," meaning their tumours neither shrank enough to count as a response nor grew enough to count as progression. The reported median time to disease progression — that is, the midpoint time before the disease was recorded as worsening — was 1.5 months. The reported median survival time was 6 months, meaning half of participants in the study survived longer than 6 months and half did not. A separate overall survival figure of 58% was also reported, though the time point this percentage refers to was not specified in the submitted data. It is worth noting that this was a small study of only 15 people, so the numbers reflect a very limited group. The data was not reported broken down in any further detail in the submission reviewed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00996333 · results posted 22 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people with pancreatic cancer, all of whom received a combination of three medicines known as GTX — Gemzar (gemcitabine), Taxotere (docetaxel), and Xeloda (capecitabine). The trial set out to measure how often tumours responded to this drug combination, how long participants survived (including how many were alive at one year), and what side effects occurred. The reported data shows that no analysed results are available for any of the outcomes — not for tumour response, survival, or side effects. According to the information submitted to ClinicalTrials.gov, the reason given is that the lead researcher (the principal investigator) left their institution before the data analysis was completed. Of the 46 people who started the trial, 33 completed it and 13 did not, but beyond those participation numbers, no further findings were reported. This means that, based on what has been submitted, it is not possible to draw any conclusions about what the GTX regimen did or did not do in this group of patients — the numbers that would ordinarily tell us that simply were not analysed or published in this record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01661114 · results posted 4 February 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01661114) enrolled 39 participants, all of whom completed the study. The trial looked at a combination chemotherapy regimen made up of three drugs — gemcitabine, 5-FU (fluorouracil), and cisplatin — given to people with advanced pancreatic or biliary (bile duct or gallbladder) cancer. The study included two groups within those 39 participants: people who had not previously received treatment, and people who had already been treated before. The reported data shows that the main thing being measured was the proportion of patients whose tumours shrank by at least 30% (called a "partial response"). According to the results reported on ClinicalTrials.gov, 40% of previously untreated patients had this level of tumour shrinkage, while 7.1% of previously treated patients did. For a secondary measure — how long patients lived overall after starting treatment (called "overall survival") — the reported data shows a median (meaning half of patients fell above this point and half below) of 10.3 months for previously untreated patients, and 4.9 months for previously treated patients. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02158039 · results posted 29 January 2016
According to the results reported on ClinicalTrials.gov, this trial involved 33 people who had cysts on their pancreas. All participants received an injection of ethanol (a type of alcohol) directly into the cyst, with the aim of shrinking or eliminating it. Of the 33 who started, 23 completed the trial and 10 did not finish. The trial was measuring two main things: whether the cysts shrank or disappeared after treatment, and whether participants experienced any unwanted health events (called adverse events) during the process. The reported data shows that when it came to adverse events — which the trial defined as things like pancreatitis (inflammation of the pancreas), bleeding, perforation, hospitalisation, surgery, or other serious occurrences — 7 participants experienced these in one reported group, and 16 in another reported grouping. Regarding the cyst size outcomes, the reported data shows measurements of 2, 10, 10, and 1 participants across different categories of response (such as complete shrinkage, partial shrinkage, or no change), though the labels identifying exactly which number corresponds to which category were not clearly reported in the submitted data, so a more detailed breakdown cannot be provided here. It is worth noting that some figures in the submitted results data appear to have incomplete labelling, which limits how precisely the numbers can be described. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00100815 · results posted 24 December 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom received a combination of three medicines: gemcitabine, capecitabine, and bevacizumab (Avastin). The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as overall survival, side effects, tumour response, and quality of life. The reported data shows that only 1 of the 50 participants was recorded as having completed the study, with 49 not completing it; however, the reason for this is not explained in the submitted data. The reported data shows that, on average, participants went approximately 5.7 months before their disease progressed, and the average overall survival was reported as 9.8 months. When looking at tumour response, 22% of participants were reported to have had their tumours shrink by a meaningful amount (defined as at least a 30% reduction in tumour size, or complete disappearance). Regarding quality of life, 56% of participants were reported to have shown an improvement based on a standard questionnaire. The reported data also shows that 70% of participants experienced side effects rated as grade 3, 4, or 5 — which, in plain terms, means moderate-to-severe or serious side effects considered to be related to the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00320749 · results posted 19 October 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people across three groups, each receiving a different dose level of a combination of three cancer medicines: capecitabine, docetaxel, and gemcitabine. Three people were in the lowest dose group, eight in the middle dose group, and ten in the highest dose group. The trial was primarily trying to find the highest dose of this drug combination that patients could tolerate without experiencing too many serious side effects — this is called the Maximum Tolerated Dose (MTD). It also looked at side effects and whether tumours showed any response to treatment. The reported data shows that the MTD identified was: docetaxel at 36 mg/m² (a measure of dose relative to body size), gemcitabine at 750 mg/m², and capecitabine at 625 mg/m². For side effects (measured using a standard grading system), the reported data shows that 29% of patients experienced one type of common toxicity, another 29% experienced a second type, and 25% experienced a third type — though the specific nature of each toxicity was not detailed in the structured data provided. Regarding tumour response, the reported data shows that 11% of patients had a partial response (meaning their tumours shrank by 30% or more), 0% had a complete response (full disappearance of tumours), and 72% had stable disease (tumours neither grew significantly nor shrank enough to count as a response). It is worth noting that a number of participants did not complete the study — particularly in the highest dose group, where nine out of ten people did not finish, though the reasons were not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01195415 · results posted 7 October 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people who all received a combination of two drugs — vismodegib and gemcitabine hydrochloride. Twenty-three participants completed the study, and two did not. The trial was primarily measuring changes in a specific type of cell (called CD44+/CD24+/ESA+ cells, a type of cell found in tumour tissue) before treatment and again after three weeks, using a laboratory technique to count those cells from needle biopsy samples. Several secondary measures were also tracked, including how many participants' tumours shrank, how long participants went without their disease getting worse, and how many experienced significant side effects. The reported data shows that the median percentage of the targeted cells in biopsy samples was 4.79% at the start of the study and 3.09% at the three-week mark. For the secondary measures, the reported data shows that 5 out of 25 participants had their tumours either disappear completely or shrink by at least 30%. The median progression-free survival — meaning the midpoint time before the disease got worse across all participants — was reported as 2.8 months. The reported data also shows that 56% of treated participants experienced side effects rated as grade 3 or higher, meaning side effects considered serious in severity according to a standard medical rating scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01239056 · results posted 21 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom had a condition called a pancreatic pseudocyst — a fluid-filled sac that can form near the pancreas. All 20 participants completed the study. The trial was measuring whether doctors could successfully place a specialised expandable metal tube (called a fully covered self-expanding metal stent) through an internal camera procedure to drain these fluid-filled sacs, and what happened to the sacs afterwards. The reported data shows that for the main measure — whether the stent could be successfully placed and drainage achieved — all 20 out of 20 participants had a technically successful procedure, with 0 reported as unsuccessful. For the follow-up measure looking at what happened to the pseudocysts afterwards, the reported data shows that 17 out of 20 participants had their pseudocyst resolve (go away), while 3 out of 20 did not. Regarding recorded adverse events (unexpected medical problems noted during the study), the data lists three separate events across the group: 2 participants experienced one type of adverse event, 1 participant experienced another, and 1 participant experienced a third — though the specific nature of these events was not described in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00201838 · results posted 14 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people in total — 30 in the experimental group and 8 in the control group. All 38 participants completed the study with none dropping out. The trial was measuring the anti-tumour effect of a treatment by looking at how many patients showed no sign of their cancer getting worse at six months, as well as other measures such as tumour response, overall wellbeing, and survival time. The reported data shows that at the six-month mark, 28% of patients in the experimental group had not experienced disease progression (meaning their cancer had not grown or spread), compared with 14% in the control group. For tumour response (whether tumours shrank or disappeared), the reported data shows a complete response — meaning all measurable signs of tumour disappeared — in 12% of the experimental group and 17% of the control group, while a partial response (tumours shrinking by at least 30%) was seen in 32% of the experimental group and 50% of the control group. Regarding overall wellbeing, 33% of the experimental group showed a clinical benefit (an improvement in at least one measure such as weight, physical function, or quality of life, sustained for at least four weeks) compared with 0% in the control group. The reported median survival time — the point by which half the patients in each group had passed away — was 5.43 months in the experimental group and 8.1 months in the control group. Measurements of certain inflammatory proteins in the blood (such as TNF) were also taken and reported as technical laboratory values, though a plain-language interpretation of those specific figures was not provided in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00925769 · results posted 7 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total across six dose groups. Six participants were in each of the first four groups, and three participants were in each of the final two groups. The trial was testing a combination of three medicines — bevacizumab, erlotinib, and capecitabine — given together at different dose levels. The main goal of Part 1 of the trial was to find the highest dose of each medicine that could be given without causing too many serious side effects (called the "maximum tolerated dose"). No participants completed the study as defined by the trial protocol, with all 30 recorded as not having completed it, though the data does not explain the reasons for each individual case. The reported data shows that, for capecitabine, the maximum tolerated dose was identified as 900 milligrams per square metre of body surface area, taken twice daily. The dose recommended to carry forward into the next part of the trial was set at 800 milligrams per square metre twice daily — the dose level just below the maximum tolerated dose, as per the trial's pre-set rules. For the other two medicines, erlotinib and bevacizumab, the reported data shows "NA" (not available) for the maximum tolerated dose, meaning a maximum tolerated dose was not determined for those two medicines within this trial; in such cases, the trial's rules specified that the highest planned dose would be used going forward. The reported data also shows that blood levels of erlotinib and capecitabine (and their breakdown products) were measured across the dose groups, with peak blood concentrations of erlotinib ranging from roughly 0.58 to 1.69 micrograms per millilitre depending on the dose group, and the time to reach those peak levels ranging from 2 to 5 hours across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01395017 · results posted 17 March 2015
According to the results reported on ClinicalTrials.gov, this trial involved 202 participants who were randomly assigned to one of two groups: 100 people received dasatinib (an additional medicine) combined with gemcitabine (a chemotherapy medicine, often abbreviated as GEM), and 102 people received a placebo (a dummy pill with no active ingredient) combined with gemcitabine. The trial was measuring how long participants lived overall, and how long they went without their disease getting worse. The reported data shows that for overall survival — meaning the number of days from the start of the trial until death from any cause — the dasatinib plus gemcitabine group had a reported median (middle value) of 375 days, while the placebo plus gemcitabine group had a reported median of 393 days. For progression-free survival — meaning the number of days until the disease was recorded as getting worse, the participant died, or they left the trial — the reported figures were 167 days for the dasatinib plus gemcitabine group and 166 days for the placebo plus gemcitabine group. It is also worth noting that the data shows zero participants were recorded as having "completed" the study in either group, which the reported data does not explain further. Any additional detail on this point was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00322712 · results posted 4 March 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00322712) enrolled 12 participants, all of whom were placed in a single treatment group. The trial was measuring how long patients survived after receiving a combination of three medicines — oxaliplatin, irinotecan, and cetuximab — given together every two weeks. Eleven of the 12 participants completed the study, and one did not complete it (the reason was not reported in the data provided). The reported data shows that the primary outcome being tracked was "time to death," meaning researchers recorded how long participants lived after starting treatment. According to the results submitted, the reported figure for survival time was 7 months. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov, so no further numbers are available to describe. It is worth noting that this was a very small trial with only 12 participants, and the results reflect only what was observed in that specific group. The reported data shows a single survival figure of 7 months, but no additional breakdown or context was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00652366 · results posted 11 February 2015
According to the results reported on ClinicalTrials.gov, this trial involved 467 people in total across five groups. All participants received a combination of two cancer medicines — gemcitabine and erlotinib. The trial was looking at whether gradually increasing the dose of erlotinib (for patients who had not developed a certain skin rash) would make a difference compared to keeping the dose the same. The two groups being directly compared in the main analysis were: 75 people on the standard dose who had not developed a significant rash, and 71 people whose dose was gradually increased and who also had not developed a significant rash. The reported data shows that, for the main outcome — how long participants survived after joining the trial — the median time was 8.4 months for the standard-dose group and 7.0 months for the escalating-dose group. By the time the data was collected, 81.3% of the standard-dose group and 85.7% of the escalating-dose group had died. For the secondary outcomes, the reported data shows that around 90.7% of the standard-dose group and 88.6% of the escalating-dose group had either experienced their cancer getting worse or had died during the study. The median time before the cancer progressed or death occurred was 19.4 weeks in the standard-dose group and 15.3 weeks in the escalating-dose group. In terms of tumour response, 14.7% of the standard-dose group and 8.6% of the escalating-dose group had their tumours shrink meaningfully and stay that way for at least four weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01470417 · results posted 9 February 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01470417) enrolled a total of 10 people with what appears to be a form of cancer (likely pancreatic, given the markers measured). Participants were split into two groups: 3 people received chemotherapy alone, and 7 received a combination of chemotherapy and chemoradiotherapy (radiation given alongside chemotherapy). All 3 people in the chemotherapy-only group completed the study, while 5 of the 7 in the combination group completed it, with 2 not finishing. The reported data shows the following across three primary measurements. For a blood marker called CA 19-9 (a substance sometimes elevated in certain cancers), the chemotherapy-only group had average levels of 383 U/mL at the start and 43 U/mL before surgery; the combination group had 550 U/mL at the start and 53 U/mL before surgery. For tumour size changes on scans — assessed using a standard system called RECIST — in the chemotherapy-only group, 1 person showed a complete response (tumour disappeared), 2 had stable disease (no significant change), and none had the disease grow; in the combination group, no one had a complete response, 5 had stable disease, and 2 had the disease grow. For surgical outcomes, the reported data shows that in the chemotherapy-only group all 3 who underwent surgery had clear margins (no tumour left at the edges), while in the combination group 3 had clear margins and 2 did not. For the secondary measure of death within 90 days after surgery, the reported data shows 0 deaths in both groups among those who had surgery (3 and 5 people respectively). It is worth noting that this was a very small trial — just 10 participants in total — so the numbers above represent individual people rather than broad trends. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00114244 · results posted 14 January 2015
According to the results reported on ClinicalTrials.gov, this trial involved 52 people in total — 15 in a group receiving sorafenib tosylate on its own (Arm I), and 37 in a group receiving sorafenib tosylate combined with gemcitabine hydrochloride (Arm II). The trial was measuring how tumours responded to these treatments, how long participants lived overall, and how long they went without their disease getting worse. The reported data shows that for the main measure — whether tumours shrank significantly (defined as a complete disappearance of tumours, or a reduction of at least 30% in tumour size) — 0 out of 15 participants in Arm I and 1 out of 37 participants in Arm II met that threshold. For overall survival (how long participants lived from the start of the trial), the reported figures were 4.3 months for Arm I and 6.5 months for Arm II. For progression-free survival (how long participants went before their disease got worse), the reported figures were 2.3 months for Arm I and 2.9 months for Arm II. It is worth noting that these survival figures are estimates based on a statistical method called Kaplan-Meier, which uses available data to calculate a middle-point estimate across the group. The reported data also shows that of those who started the trial, 13 out of 15 in Arm I and 30 out of 37 in Arm II completed the study, with 2 and 7 participants respectively not completing it; however, the reasons for not completing were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01232829 · results posted 26 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people, all of whom completed the study — none dropped out. Every participant received the study treatment, a drug called RO4929097. The trial was set up to measure how many participants were still alive at six months, as well as how long participants survived overall and how long it took before their disease got worse. The reported data shows that out of the 18 participants, 5 were alive at the six-month mark — this was the main thing the trial was designed to measure. For overall survival, the reported middle-point figure (meaning half of participants lived longer than this and half did not) was 4.1 months. For the time until the disease got worse, the reported middle-point figure was 1.5 months. These figures are based on a standard statistical method used to estimate survival over time in a group of patients. The reported data shows only the numbers described above; no other outcome figures were included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01419769 · results posted 19 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people, all of whom received a device called the AXIOS Stent and Delivery System. The trial was looking at a small stent (a tiny tube placed inside the body to keep a passage open) used to drain a pancreatic pseudocyst — a fluid-filled sac that can form near the pancreas. Of the 33 people who started, 29 completed the study. The trial was measuring two main safety outcomes related to complications at the treatment site, as well as several secondary outcomes around how well the stent functioned and whether the cyst reduced in size. The reported data shows that for the two primary (main) safety outcomes, 100% of participants were reported as free from bleeding at the access site that required a blood transfusion, and 96.6% were reported as free from infection at the access site that required antibiotics given by injection or drip, or a longer hospital stay. For the secondary outcomes, the stent was reported to be open and unblocked (patent) at 30 and/or 60 days in 93.1% of participants, and successfully removable at 30 and/or 60 days in 96.7% of participants. Technical success — meaning the stent was placed and later removed as planned — was reported for 30 participants at placement and 29 at removal. Clinical success, defined as the pseudocyst shrinking by at least 50% in size by 30 and/or 60 days, was reported in 86.2% of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00965718 · results posted 16 September 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00965718) enrolled 20 people who received a treatment called Immuncell-LC. There was only one group — no comparison group. Of the 20 who started, 16 completed the trial and 4 did not. The trial was measuring how often the disease was kept under control (meaning it shrank, partially shrank, or stayed stable rather than getting worse), how long participants lived overall, how long it took for the disease to get worse, and how participants rated their quality of life. The reported data shows that, looking at the main result — called the "disease control rate" — 25% of participants had their disease classified as either completely gone, partially reduced, or stable. Breaking that down further, 4 out of the 16 participants who completed the trial were recorded as having stable disease; the data does not separately report how many, if any, had a complete or partial response. For overall survival — meaning the time from joining the trial until death from any cause — the reported median figure was 26.6 weeks. The reported median time until the disease got worse was 11 weeks. Quality of life was measured using two standard questionnaires (the QLQ-C30 and a pancreatic-cancer-specific add-on called the QLQ-PAN26), and multiple scores across different areas of wellbeing were reported; however, because the data as submitted does not label which score belongs to which specific area, a detailed breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00593866 · results posted 27 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people, all of whom completed the study. Participants had pancreatic cancer (specifically, a type called adenocarcinoma) that could not be surgically removed. The trial was testing how high a radiation dose could be delivered alongside a chemotherapy drug called gemcitabine, using a precise form of radiation therapy, before side effects became too severe. It also looked at how many participants showed no sign of the cancer growing in the treated area after two years. The reported data shows that the highest radiation dose that could be delivered under the trial's conditions was 55 Gray (Gray, or Gy, is simply the unit used to measure radiation dose). This figure represents what the researchers identified as the maximum tolerated dose — that is, the highest level tested before side effects were considered unacceptable. For the secondary measure, the reported data shows that 59% of participants had no local progression (meaning the cancer had not grown in the treated area) at the two-year mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01214720 · results posted 13 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 607 people with cancer across two groups. One group of 306 participants received a combination of three medicines — bevacizumab, gemcitabine, and erlotinib — while the other group of 301 participants received gemcitabine and erlotinib plus a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how long participants lived overall, and also tracked how long the disease took to worsen, as well as how tumours responded to treatment at early check-ups. The reported data shows that, for overall survival, the median time from enrolment until death was 7.1 months in the three-medicine group and 6.0 months in the placebo group. ("Median" simply means the midpoint — half of participants in each group lived longer than this, and half did not reach it.) By the end of the study period, 72.2% of people in the three-medicine group and 77.4% in the placebo group had died. For disease progression — meaning the point at which the cancer was recorded as getting worse — the median time was 4.6 months in the three-medicine group and 3.6 months in the placebo group, with 84.0% and 92.4% of participants respectively having experienced a progression or death event by the study's end. At the first tumour check after starting treatment, 62.1% of the three-medicine group and 58.5% of the placebo group showed either no tumour growth or some degree of shrinkage. The Clinical Benefit Response secondary outcome was listed in the trial but no numbers were reported for it in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01124786 · results posted 17 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 367 people in total — 182 in the CO-1.01 group and 185 in the Gemcitabine group. The trial was comparing these two treatments in people with a specific characteristic related to a protein called hENT1 (a marker found in tumour cells that may influence how certain medicines work). The main thing the trial set out to measure was how long participants with low levels of this hENT1 protein lived overall, comparing the two groups. A number of secondary things were also planned to be measured, including survival in all participants, tumour response rates, a blood marker called CA19-9, pain levels, and how well participants tolerated the treatments. The reported data shows that, for the primary outcome — overall survival in people with low hENT1 expression — the CO-1.01 group had a reported median survival (meaning the point at which half of the participants in that group had passed away) of 5.7 months, while the Gemcitabine group had a reported median survival of 6.1 months. These are the only numerical results provided in the submitted data. For all of the secondary outcome measures — including overall survival across all participants, tumour response rates, CA19-9 response, pain changes, and tolerability — the data was not reported in the structured results submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00390182 · results posted 9 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people who received a combination treatment of the chemotherapy drug gemcitabine together with a technique called low dose fractionated radiation therapy (a method of delivering small amounts of radiation across multiple sessions). Of the 38 who started, 33 completed the study and 5 did not. The trial was primarily measuring how many participants' tumours responded to the treatment, using a standard set of measurement rules called RECIST, which looks at changes in tumour size on medical scans. The reported data shows that out of all participants, 3 people had what was classified as an "overall response" — meaning their tumours either disappeared completely or shrank by at least 30%. Two additional figures were also reported: around 63% of participants had cancer that had spread to the liver at some point during the study, and the reported data shows a figure of 7.5 months related to the time participants had locally advanced or returning disease without it having spread to distant parts of the body. It is worth noting that some outcome details, such as a breakdown of complete versus partial responses, were not separately reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01020006 · results posted 2 April 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01020006) involved 42 people in total. It was split into two parts: Part A included 8 participants who received a combination of PCI-27483 and gemcitabine (two medicines), while Part B included 18 participants who received that same combination and 16 participants who received gemcitabine alone. The trial was looking at unwanted or unexpected health events — called adverse events — that occurred during treatment. The reported data shows that none of the participants in any group were recorded as having "completed" the study — all 42 participants fell into the "not completed" category, though the data does not explain the reasons for this. For the primary outcome, which measured the number of participants who experienced treatment-related adverse events (that is, any health issues that arose during the study period), the reported figures show that 8 out of 8 participants in Part A, 18 out of 18 in the PCI-27483 plus gemcitabine group in Part B, and 16 out of 16 in the gemcitabine-only group in Part B recorded at least one such event. No further detail about the nature or severity of those events was included in the submitted results data. No secondary outcome data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00769652 · results posted 7 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 7 people — 6 in the "Medical Nutrition Therapy" group and 1 in the "Standard Care" group. All 7 participants completed the study with no drop-outs. The trial was measuring changes in three things over time: body weight, fat-free mass (the part of the body made up of muscle, bone, and other tissue rather than fat), and a nutrition assessment score called the PG-SGA (a tool used to rate a person's nutritional status based on symptoms and physical signs). The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the three primary outcome measures. In other words, the actual figures for changes in weight, fat-free mass, and PG-SGA scores were not reported in the structured results data, so it is not possible to describe what those measurements showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00844649 · results posted 11 December 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00844649) enrolled 861 adults with pancreatic cancer — 431 in the group receiving a combination of two medicines (albumin-bound paclitaxel, also called ABI-007, plus gemcitabine) and 430 in the group receiving gemcitabine alone. The trial's main goal was to measure how long participants lived overall, and it also tracked how long their disease stayed stable before it progressed, as well as how many participants' tumours shrank or disappeared according to scans reviewed by independent specialists. The reported data shows that the median overall survival — that is, the midpoint time at which half the participants in each group had died — was 8.5 months in the combination group and 6.7 months in the gemcitabine-only group. For progression-free survival (the midpoint time until the disease worsened or participants died), the reported figures were 5.5 months in the combination group and 3.7 months in the gemcitabine-only group. When it came to tumour response, 23% of participants in the combination group were reported to have had their tumour shrink or disappear based on independent scan review, compared with 7% in the gemcitabine-only group. The reported data also shows that dose reductions and interruptions occurred in both groups during the treatment period, though the specific breakdown figures for each sub-category were not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00735917 · results posted 5 December 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all of whom completed the study. Every participant received the study drug, saracatinib. The trial was set up to measure how many people were still alive at six months, as well as broader outcomes including how long people lived overall, whether tumours shrank, and how long it took for the disease to get worse. The reported data shows that 11% of participants (roughly 2 out of 19 people) were still alive at the six-month mark. The median overall survival — meaning the point in time by which half of participants had died — was reported as 2.5 months. No participants were recorded as having a confirmed tumour response, meaning no one's tumour completely disappeared or shrank by the threshold amount required to count as a response under the criteria used. Because no responses were observed, the "duration of response" figure was not reported. The time until the disease got worse or death occurred — known as progression-free survival — had a median of 1.6 months. The reported data shows only numbers from a single group of 19 people, with no comparison group, so the figures reflect only what was observed in this small group of participants receiving saracatinib. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00837031 · results posted 13 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants, all of whom were assigned to receive a combination of two medicines called lenalidomide and gemcitabine. All 72 participants were recorded as having completed the study. The trial was measuring how long participants lived after starting treatment, and specifically whether they were still alive at the six-month mark. The reported data shows that the main thing being measured — the percentage of participants estimated to be alive six months after starting treatment — was 37%. For the additional measures, the reported data shows that the middle point for "progression-free survival" (meaning the length of time before a participant's disease was recorded as getting worse) was 2.3 months. The middle point for overall survival (meaning the length of time from starting treatment until death) was reported as 4.7 months. These middle-point figures are known as "median" values, which simply means half the participants fell above that number and half fell below it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00959946 · results posted 22 February 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00959946) enrolled 32 people in total across eight different dose combination groups. It was testing two drugs together — bosutinib and capecitabine — at various dose levels in people with advanced breast cancer. The main goals of the first part of the trial were to find the highest dose combination that participants could tolerate without experiencing serious side effects (called the "maximum tolerated dose"), and to track how many participants experienced adverse events (unwanted medical occurrences) or serious adverse events during treatment. A second part of the trial was planned to test the chosen dose combination further, but the reported data shows no measurements were recorded for any of the Part 2 outcome measures. The reported data shows that, across all eight dose groups in Part 1, 100% of participants experienced at least one adverse event during treatment. Regarding serious adverse events, the data was only partially reported — figures were provided for four of the eight groups, ranging from 0% to 50% of participants in those groups. For the maximum tolerated dose finding, the reported results indicate that no recommended dose was identified for the bosutinib-plus-capecitabine-625 mg/m² or the bosutinib-plus-capecitabine-750 mg/m² combinations. For the highest capecitabine dose level (1000 mg/m²), a bosutinib dose of 300 mg was reported as the maximum tolerated dose. For the secondary measure looking at tumour response in Part 1, the reported data shows that no participants across any of the eight dose groups achieved a complete or partial response (meaning no recorded cases of tumours disappearing or shrinking by at least 30%). The reported data for Part 2 of the trial — which was intended to look at tumour response rates, progression-free survival (how long before the disease worsened), and clinical benefit — contains no measurements, suggesting Part 2 either did not proceed or results were not submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00574275 · results posted 25 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 546 people in total — 275 in the placebo-plus-gemcitabine group and 271 in the aflibercept-plus-gemcitabine group. The trial was measuring how long participants lived overall, how long their disease took to get worse, and how many experienced adverse events (unwanted health effects during the study). It is important to note that the trial was stopped early because an independent review concluded it was unlikely to show a meaningful difference between the two groups — a decision the researchers called "futility." The reported data shows that the median overall survival (that is, the midpoint time after which half the participants had died) was 7.75 months in the placebo-plus-gemcitabine group and 6.54 months in the aflibercept-plus-gemcitabine group. For progression-free survival — the time until the disease was recorded as getting worse or until death — the reported median was 3.71 months in both groups. Two other planned measurements (tumour response rate and clinical benefit/symptom scores) were not analysed because the trial was stopped early, so those figures were not reported. Regarding adverse events, the reported data shows that out of those who received treatment, 257 people in the placebo group and 266 in the aflibercept group experienced at least one treatment-related adverse event; serious adverse events were recorded in 122 and 148 people respectively; adverse events leading to death were recorded in 43 and 55 people respectively; and adverse events leading to stopping treatment permanently were recorded in 32 and 76 people respectively. A small number of participants in each group (5 in each) were reported to have developed antibodies against the study drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00219557 · results posted 24 August 2012
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — axitinib and gemcitabine — compared to gemcitabine alone, in people with pancreatic cancer. The trial ran in two stages: a small Phase 1 lead-in stage (8 participants) to check the dosing of the medicines, followed by a larger Phase 2 stage where 69 people received the combination and 34 received gemcitabine alone. The main thing the trial was measuring was overall survival — that is, how long participants lived after joining the trial. The reported data shows that, in the Phase 2 part, participants in the axitinib plus gemcitabine group had a reported median overall survival of 210 days, while those in the gemcitabine-only group had a reported median overall survival of 171 days. (Median means that half the participants in each group lived longer than that number of days, and half lived for a shorter time.) In the Phase 1 lead-in stage, the reported data shows that none of the 8 participants experienced what the trial defined as a dose-limiting side effect, which was used to confirm the doses to be carried forward. Some additional measurements of how axitinib moved through the body were also recorded for the Phase 1 participants, but these were technical pharmacology figures rather than patient outcome measures. The reported data also shows that in the Phase 2 stage, almost all participants in both groups did not complete the trial as initially planned — only 1 participant in the gemcitabine-alone group was recorded as having completed it. The reasons for non-completion were not broken down further in the data available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00471146 · results posted 16 July 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 314 people in the axitinib-plus-gemcitabine group and 316 people in the placebo-plus-gemcitabine group — a total of 630 participants. The trial was studying whether adding axitinib (a targeted medicine) to gemcitabine (a chemotherapy medicine) made a difference for people with pancreatic cancer. The main thing being measured was how long participants lived overall, and secondary measurements included how long it was before the cancer got worse, how many participants saw their tumours shrink, and how participants rated their quality of life. The reported data shows that for overall survival (how long participants lived from the start of the trial), the axitinib-plus-gemcitabine group had a median of 36.9 weeks, compared with 35.8 weeks in the placebo-plus-gemcitabine group. (Median means half the participants in each group lived longer than this figure and half lived a shorter time.) For progression-free survival (how long until the cancer got worse or a participant died), the reported figures were 19.1 weeks in the axitinib group and 18.9 weeks in the placebo group. The percentage of participants whose tumours shrank meaningfully was reported as 4.9% in the axitinib group and 1.6% in the placebo group. Among those whose tumours did shrink, the reported duration of that response was 33.1 weeks in the axitinib group; a figure was not reported for the placebo group. Quality-of-life scores, measured using two standard questionnaires, were broadly similar between the two groups at the time points assessed, with small changes from starting scores reported in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00666926 · results posted 14 June 2012
According to the results reported on ClinicalTrials.gov, this trial tested a drug called PF-00562271 in people with cancer. A total of 99 participants took part, spread across 16 different dose groups — some taking the drug twice a day (BID) at doses ranging from 5 mg to 150 mg, and others taking it once a day (QD) at doses ranging from 125 mg to 225 mg. The trial was an early-phase study primarily looking at two things: whether certain serious side-effect thresholds (called "dose limiting toxicities") were reached in the first treatment cycle, and — in one group — whether tumours showed a reduction in activity on a specialised scan (FDG-PET). The reported data shows that, for the dose limiting toxicity measure, only 2 participants across all groups recorded such an event — one person in the 105 mg twice-daily group, and one person in the 125 mg twice-daily group. All other dose groups recorded zero participants reaching those thresholds in the first cycle. For the tumour scan measure — which was only assessed in the 125 mg twice-daily group — the reported data shows that 50% of participants in that group had a reduction of 15% or more in tumour activity on the FDG-PET scan. The reported data also shows figures for how quickly and how high the drug concentration rose in the blood at various doses; in general, higher doses were associated with higher peak blood levels of the drug, though full data was not reported for every group across every time point. It is worth noting that the data shows zero participants recorded as having "completed" the study in any group, though the reason for this is not explained in the structured results and should not be interpreted without the full study context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00363051 · results posted 30 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people with neuroendocrine tumours across two groups. The first group of 115 participants received a drug called everolimus on its own, while the second group of 45 participants received everolimus combined with another medicine called octreotide depot. The trial's main goal was to measure how many participants' tumours shrank or disappeared — what researchers call an "objective response" — based on scans reviewed by an independent radiology team. The reported data shows that in the first group (everolimus alone), 9.6% of participants had their tumours shrink or disappear sufficiently to count as a response. Among those in this group who did respond, the reported data shows that response lasted a median of around 10.64 months (meaning half of responders had a response lasting longer than this, and half shorter). In the second group (everolimus plus octreotide depot), 4.4% of participants were recorded as having a response. The reported data for how long responses lasted in the second group was not reported in the submitted results. The reported data also shows that in the first group, all 115 participants experienced at least one adverse event (an unwanted health change recorded during the study), 63 experienced a serious adverse event (a more significant medical event such as one requiring hospitalisation), and 10 deaths were recorded during the study period. In the second group of 45 participants, all 45 experienced at least one adverse event, 27 experienced a serious adverse event, and 2 deaths were recorded. These figures cover events that occurred during the study and do not on their own indicate whether the events were caused by the treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00510068 · results posted 15 December 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00510068) enrolled 410 people with advanced pancreatic neuroendocrine tumours — 207 were assigned to receive everolimus (10 mg per day) and 203 received a placebo (an inactive tablet). The trial then moved into an open-label phase where 225 participants received everolimus. The main thing the trial was measuring was how long participants went without their disease getting worse — known as "progression-free survival." Researchers also tracked whether tumours shrank, and how long participants lived overall. The reported data shows that, on average, participants in the everolimus group went approximately 11 months before their disease progressed, compared with approximately 4.6 months in the placebo group. For overall survival — meaning the time from the start of the study until death from any cause — the reported figures were approximately 44 months for the everolimus group and approximately 37.7 months for the placebo group. Regarding tumour shrinkage, the reported data shows that about 4.8% of participants in the everolimus group showed a measurable reduction in tumour size (either partial or complete), compared with 2.0% in the placebo group. The trial also looked at these outcomes broken down by certain biological markers measured in participants' blood and tumour tissue, with varying figures reported across those subgroups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00042939 · results posted 19 July 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in one group (receiving irinotecan and docetaxel together) and 46 people in a second group (receiving those same two medicines plus a third medicine called cetuximab). The trial was measuring how often tumours responded to these treatment combinations, how long it took for the disease to get worse, how long participants lived overall, and some other factors including whether a particular protein marker was present on tumour cells and the rate of blood clot events. The reported data shows that when looking at tumour response — meaning the proportion of people whose tumours shrank meaningfully or disappeared — the figure was 0.045 (roughly 4–5 in every 100 people) in the irinotecan/docetaxel group, and 0.07 (roughly 7 in every 100 people) in the group that also received cetuximab. For how long it was before the disease progressed, the reported median (the midpoint figure in the group) was 3.9 months in the first group and 4.5 months in the second group. For overall survival, the reported median was 6.5 months in the first group and 5.3 months in the second group. Regarding blood clot events, the reported proportion was 0 in the first group and 0.023 (about 2 in every 100 people) in the cetuximab group. The reported data also shows that tumour tissue with sufficient information about the EGFR protein marker was available for 30 participants in the first group and 31 in the second group, though detailed breakdown of those results was only partially reported in the submitted data. Any figures not fully described here were not reported in a way that allowed a plain summary to be made. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00057876 · results posted 25 March 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00057876) enrolled 74 people in total — 38 in a group receiving gemcitabine (a chemotherapy medicine) alone, and 36 in a group receiving gemcitabine combined with radiation therapy. The trial was studying treatments for cancer, and its main goal was to measure how long participants lived overall. It also tracked how long participants went without their disease getting worse, and how many showed a measurable reduction in their cancer. The reported data shows that, for overall survival — measured from when a participant joined the trial until death from any cause — the median time (meaning the point by which half of participants had died) was 9.2 months in the gemcitabine-only group and 11.0 months in the gemcitabine-plus-radiation group. For progression-free survival — the time until the cancer grew or the participant died, whichever came first — the reported median was 6.7 months in the gemcitabine-only group and 6.0 months in the combined treatment group. Regarding overall response (participants whose cancer either disappeared completely or shrank by a meaningful amount), the reported data shows 2 participants out of 34 eligible treated participants responded in each group. It is worth noting that the data as submitted does not include further detail about side effects or other safety information in this structured results section. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00683085 · results posted 17 December 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled just 2 participants, both of whom completed the study. Participants received a peptide treatment (1 mg, given twice a week for 8 weeks) alongside the chemotherapy drug gemcitabine. The trial was looking at two things: first, how many participants avoided certain serious side effects (specifically, severe blood-related side effects or other serious side effects as defined by a standard medical grading system); and second, how many participants experienced a meaningful shrinkage in their tumour size as measured by CT scan. The reported data shows that 1 out of the 2 participants did not experience the serious side effects the trial was monitoring for. For the second measure — tumour shrinkage — the reported data shows that 0 out of the 2 participants had their tumours shrink by more than 30%, which was the threshold used to count as a response in this trial. It is important to note that with only 2 participants, these numbers are extremely limited and cannot be used to draw broad conclusions about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00383149 · results posted 19 October 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all of whom received a combination of two medicines called ixabepilone and cetuximab. The trial was measuring how many people were still alive six months after starting treatment, as well as a number of secondary measures related to how their tumours responded and how long certain outcomes lasted. The reported data shows that none of the 54 participants were recorded as having "completed" the study in the traditional sense — all 54 were listed under "not completed," which likely reflects the nature of the disease being studied rather than dropouts in the usual meaning. The reported data shows that 57.4% of participants were still alive at the six-month mark, which was the main thing the trial set out to measure. Looking at tumour responses — assessed using a standard set of measuring rules called RECIST — no participants had a complete disappearance of their tumour, 4 had a meaningful shrinkage (called a partial response), 24 had stable disease (meaning the tumour neither grew significantly nor shrank enough to count as a response), 2 had their disease progress (meaning the tumour grew), and 1 participant's response was not able to be assessed. Overall, about 12.9% of participants showed an objective tumour response (meaning at least a meaningful shrinkage). The reported median time before the disease progressed or death occurred was 3.9 months, the median overall survival time from the first dose was 7.6 months, and among those who did respond to treatment, the median duration of that response was reported as 5.7 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00428597 · results posted 11 October 2010
According to the results reported on ClinicalTrials.gov, this trial (NCT00428597) enrolled 171 people — 86 in the sunitinib group and 85 in the placebo group — though 83 and 82 respectively actually received their assigned treatment. The trial was measuring how long people went without their disease getting worse (called progression-free survival), as well as a number of secondary outcomes including how many people's tumours shrank, how long any shrinkage lasted, overall survival, and quality of life. The reported data shows that for the primary outcome — time until the disease progressed or the person died — the sunitinib group had a reported median (middle value) of 11.4 months, compared with 5.5 months in the placebo group. For the secondary outcomes, 8 participants in the sunitinib group had their tumours shrink to a measurable degree; among those 8 people, the reported duration of that response was a median of 8.1 months, and it took a median of 3.1 months from the start of the trial for that response to first appear. For overall survival, a median of 20.6 months was reported for the sunitinib group only — the reported data notes the study was terminated early and that the overall survival figures were not mature enough at the time of analysis to produce a reliable estimate for either group using standard statistical methods. No overall survival median figure for the placebo group was reported in the data provided. The reported data also includes quality-of-life scores measured using a standard questionnaire (scored from 0 to 100, where higher scores indicate better quality of life). Scores at various time points across the study hovered in a broadly similar range for both groups — generally between approximately 62 and 67 for the sunitinib group and 62 to 65 for most of the placebo group's time points, with the placebo group's final reported time point sitting at 56.7 compared with 66.9 for the sunitinib group. The data did not report how many participants contributed to each of these time-point scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.