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Reported trial results for Stomach Cancer

Every Stomach 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.

112 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

  • NCT04879368 · results posted 10 June 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04879368) enrolled 462 people with advanced gastric or other related cancers, split into two groups: 309 people received a combination treatment called "RegoNivo" and 153 received standard of care. The trial was primarily measuring how long participants lived overall (called overall survival), and also tracked a number of secondary measures including how long before the disease got worse, how many people's tumours shrank, and how participants' physical wellbeing and quality of life held up over time. The reported data shows that for overall survival — the main outcome — the RegoNivo group had a median (the midpoint value, where half lived longer and half shorter) of 5.91 months, compared with 6.28 months in the standard of care group. For progression-free survival (how long before the disease worsened or death occurred), the reported median was 1.91 months for RegoNivo and 1.87 months for standard of care. Regarding tumour response, 23 participants in the RegoNivo group and 4 in the standard of care group were reported to have had their tumour shrink or disappear. For quality-of-life measures tracking physical function and general health status, the reported data shows that at 6 months roughly 6.9% of RegoNivo participants and 5.6–6.3% of standard of care participants had not experienced a meaningful decline; at 12 months those figures were approximately 3.9% and 0.7% respectively. Biomarker identification was listed as an additional pre-specified goal, but no numerical results for that measure were 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04736485 · results posted 14 April 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04736485) enrolled 67 participants, all of whom were placed in a single experimental treatment group. All 67 participants completed the study with none dropping out. The trial was measuring how well a pre-operative (before surgery) treatment could shrink or eliminate tumour tissue in people with stomach or related cancers, as judged by a pathologist examining tissue removed during surgery. The reported data shows that out of the 67 participants, 20 were recorded as having a pathologic complete response — meaning no remaining tumour cells were found in their surgically removed tissue. Separately, 61 out of 67 participants were reported to have had a "margin-free" surgical removal, meaning the surgeon was able to remove the tumour without leaving any visible or microscopic tumour behind at the edges of the removed tissue. The reported data also shows that all 67 participants experienced at least one treatment-related adverse event (an unwanted or unexpected health occurrence noted during the study). For two other outcomes that were planned to be measured — how long participants went without their disease progressing, and how long participants survived overall — the data was 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05525286 · results posted 17 November 2025

    According to the results reported on ClinicalTrials.gov, this trial tested an experimental drug called SOT102 in people with cancer. The trial had two main parts: Part A tested SOT102 on its own at four increasing dose levels (ranging from 0.032 mg/kg up to 0.214 mg/kg), and Part B tested SOT102 alongside standard-of-care treatment at the lowest dose level. In total, 31 participants were enrolled across these groups — 4 at the lowest monotherapy dose, 11 at the second dose, 9 at the third dose, 3 at the highest dose, and 4 in the combination group. The trial was designed to find the highest dose that could be given without too many serious side effects (called the Maximum Tolerated Dose) and to identify a recommended dose for future studies. The trial was terminated early after a safety signal — an unexpected pattern of concerns — appeared repeatedly across different dose levels and was reviewed by an independent safety committee. The reported data shows that, for the primary goal of identifying a recommended dose, no result was able to be determined — the data submitted simply records "not available" for both the monotherapy and combination groups, because the trial was stopped before that could be established. A planned later stage of the trial (Parts C and D), which would have looked at how well the treatment affected tumours, was never reached and has no data reported. Regarding the secondary measurements, the reported data shows that across all groups, 30 out of 31 participants experienced at least one treatment-emergent adverse event (an unwanted health change that appeared or worsened during treatment). Events that met the formal definition of a dose-limiting toxicity — meaning a side effect serious enough to signal the dose may be too high — were reported in 1 participant in the second dose group and 1 participant in the third dose group, and none in the other groups. The number of participants whose adverse events were considered possibly linked to SOT102 ranged from 2 to 6 across the different dose groups, while all 4 participants in the combination group also had adverse events considered possibly linked to the standard-of-care 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 ↗

  • NCT03797326 · results posted 17 November 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03797326) enrolled a total of 611 participants across eight groups, each covering a different cancer type: triple negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer (two separate groups — one receiving a combination treatment and one receiving a single treatment), glioblastoma (a type of brain tumour), biliary tract cancer, and pancreatic cancer. The trial was measuring how tumours responded to treatment combinations involving lenvatinib (referred to as "Lenva") and pembrolizumab (referred to as "Pembro"), or lenvatinib alone in one colorectal group. No participants were recorded as having formally "completed" the study, and all participants were listed as "not completed," which the data does not explain further. The reported data shows several outcomes were tracked. One measure — called "Disease Control Rate" — recorded the percentage of participants whose disease showed a complete disappearance, partial shrinkage, or stabilisation of tumours. For the breast cancer group this figure was reported as 51.6%, and for the ovarian cancer group it was 77.4%. For the remaining cancer groups (assessed by an independent central review rather than the treating doctor), the reported figures ranged from 37.9% in the pancreatic cancer group up to 64.7% in the biliary tract cancer group. Another measure tracked how long a response lasted (in months) among those who did show a response. The reported data shows this ranged from 4.6 months (glioblastoma group) to 22.9 months (breast cancer group); the colorectal cancer single-treatment group's duration of response was not reported. The trial also measured "progression-free survival" — the length of time participants went without their disease worsening — which ranged from 2.1 months (pancreatic cancer) to 6.1 months (ovarian cancer) across all 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 ↗

  • NCT04189445 · results posted 8 October 2025

    According to the results reported on ClinicalTrials.gov, this trial investigated a drug called futibatinib in people with certain cancers. Participants were divided into groups — Cohort A (87 people) and Cohort B (28 people). A third group, Cohort C, was listed but had no participants enrolled. The trial was measuring how many participants experienced a meaningful shrinkage of their tumours, how long any such response lasted, and how long participants went without their disease getting worse. The reported data shows that the main outcome measured — the proportion of participants whose tumours shrank significantly (either partially or completely), as assessed by an independent review team — was 6.9% in Cohort A and 17.9% in Cohort B. When the treating doctors made the same assessment themselves, the figures were 9.2% in Cohort A and 10.7% in Cohort B. For those participants whose tumours did shrink, the reported data shows the response lasted a median (middle value) of 5.6 months in Cohort A and between 3.9 and 5.6 months in Cohort B, depending on whether the independent reviewers or the doctors did the assessment. No data was reported for Cohort C on any of these measures. The trial also tracked how long participants went without their disease progressing: the reported median was 1.9 months in Cohort A and 2.9 months in Cohort B. No participant was recorded as having completed 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT04164979 · results posted 11 August 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 27 adults with advanced stomach or gastro-oesophageal cancer (a cancer affecting the stomach and the junction where the oesophagus meets the stomach). All 27 participants completed the study. Everyone received a combination of two medicines — cabozantinib and pembrolizumab — and the trial was primarily measuring how many people were still free from their cancer getting worse at the 6-month mark. Several additional outcomes were also tracked, including how many people experienced serious side effects, how many showed a measurable reduction in tumour size, and how long participants lived overall. The reported data shows that, of the 27 participants, 6 were free from disease progression (meaning their cancer had not visibly worsened, and they had not died or clinically deteriorated due to their disease) at 6 months. Regarding serious side effects, 3 participants experienced what are classified as Grade 3–5 adverse events — these are unwanted health effects considered severe to life-threatening in severity. For tumour response, only 1 participant had a confirmed measurable reduction in tumour size meeting the study's definition (either the tumour disappearing completely or shrinking by at least 30%). The reported median overall survival — meaning the point at which half the group had passed away and half had not — was 5.5 months. No data was reported for individual complete or partial response numbers beyond the combined figure of 1 participant. 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 ↗

  • NCT05011058 · results posted 28 July 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05011058) enrolled a total of 102 participants across eight different types of lymphoma (a cancer of the lymphatic system). The groups included people with Diffuse Large B-Cell Lymphoma (9 people), Extranodal Natural Killer/T-Cell Lymphoma (11), Peripheral T-Cell Lymphoma receiving combination therapy (38), Peripheral T-Cell Lymphoma receiving a single treatment (10), Hodgkin Lymphoma (8), Post-Transplant Lymphoproliferative Disorders (3), HIV-Associated Lymphomas (3), and other Epstein-Barr virus (EBV)-positive lymphomas (20). The trial's main goal was to measure what proportion of participants had their tumours shrink or disappear — this is called the "objective response rate." The reported data shows that, for the primary measure of tumour shrinkage or disappearance, responses were recorded in only a small number of participants across all groups. Specifically, 11 out of 38 participants responded in the Peripheral T-Cell Lymphoma combination therapy group, 1 out of 10 in the Peripheral T-Cell Lymphoma monotherapy group, and 2 out of 20 in the other EBV-positive lymphoma group. No responses were recorded in the remaining five groups. For participants who did respond, the reported data shows how long that response lasted (called "duration of response"): a median of 98 days in the combination therapy group, 43 days in the monotherapy group, and 163.5 days in the other EBV-positive lymphoma group. Note that data for time to next treatment was not reported in the submitted results. The reported data also shows figures for how long participants went without their disease worsening (called "progression-free survival"), ranging from a median of 79 days in the Post-Transplant group to 124 days in the Peripheral T-Cell Lymphoma combination therapy group across all eight groups. For overall survival — meaning the time from starting treatment until death from any cause — the reported median figures ranged from 108 days in the HIV-Associated Lymphomas group up to 570.5 days in the Hodgkin Lymphoma group, with the remaining groups falling in between. These figures are medians, meaning half of participants in each group reached that point sooner, and half later. 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 ↗

  • NCT05104567 · results posted 1 July 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05104567) enrolled 138 adults in total across seven groups, each made up of people with one of several different advanced gastrointestinal cancers — including oesophageal, stomach, liver, and bowel cancers. Participants had already received prior treatments. Each group received a combination of the investigational drug pegenzileukin with either pembrolizumab or cetuximab (both existing cancer medicines). The main thing the trial was measuring was the **objective response rate (ORR)** — that is, the proportion of participants whose tumours shrank by a meaningful amount or disappeared entirely according to standardised imaging criteria. The reported data shows the following ORR figures for each group: in the oesophageal cancer group (Cohort A, 5 participants), 20% of participants met the response criteria. In the stomach/gastro-oesophageal junction cancer groups, the figures were 13.6% (Cohort B1, 22 participants), 5.3% (Cohort B2, 19 participants), and 11.1% (Cohort B3, 18 participants). In the liver cancer group (Cohort C, 20 participants), the figure was 5%. For the bowel cancer groups, 0% of participants in Cohort D1 (30 participants) and 8.3% in Cohort D2 (24 participants) met the response criteria. The reported data also shows that the time from starting treatment until a response was first recorded ranged from approximately 1.9 to 6 months across the groups that had any responses; no time-to-response figure was reported for Cohort D1, which recorded no responses. The number of participants who experienced treatment-emergent adverse events (unwanted medical occurrences that arose or worsened during the treatment period) was reported for most groups, with the data showing this occurred across all groups, though the full breakdown of serious adverse events was not completely reported in the submitted data for all cohorts. 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 ↗

  • NCT03008278 · results posted 4 June 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — olaparib and ramucirumab — in people with cancer. The study ran in two parts: a Phase 1 portion to find a safe starting dose, and a Phase 2 portion to look at how many patients' tumours responded to the treatment. A total of 51 people were enrolled across three groups (3 in an early Phase 1 level, 8 in a later Phase 1 level, and 40 in Phase 2). Of those, only a small number completed the study as planned — 3, 6, and 1 respectively — with most participants in Phase 2 not completing the study. The reported data shows that in Phase 1, when looking at serious side effects that would limit the dose (called "dose-limiting toxicities"), 0 were recorded at one dose level and 1 at another. For the main Phase 2 measure — how many patients' tumours shrank or disappeared (called "objective response") — 5 out of the 40 participants in that phase were reported to have responded. For the secondary measures, the reported data shows that the time participants went without their disease getting worse (progression-free survival) was 4.1 months for the first Phase 1 group, 2.3 months for the second Phase 1 group, and 4.0 months for the Phase 2 group. The time participants remained on the study overall (overall survival) was reported as 5.5, 6.9, and 7.3 months for those same three groups respectively. The reported data also includes results broken down by a genetic marker called HRD (homologous recombination deficiency), which relates to how cancer cells repair their DNA. Among participants who tested positive for this marker, progression-free survival was reported as 5.3 months, compared with 2.7 months for those who tested negative. Overall survival figures for the HRD-positive group were reported as 13.5 months, compared with 7.3 months for the HRD-negative 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 ↗

  • NCT04383938 · results posted 13 May 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — APR-246 and pembrolizumab — in people with solid tumours (cancers that form lumps or masses). A total of 40 people took part across four groups: a "Safety Lead In" group (6 people), and three "Expansion" groups (8, 5, and 21 people respectively). The trial had two main goals: to track how often participants experienced treatment-related side effects or serious medical events, and to find a recommended dose of APR-246 to use in later research. The reported data shows that, when counting how many participants experienced treatment-related adverse events (unwanted medical events that occurred during the trial) or serious adverse events, all participants in each group were counted — that is, 6 people in the Safety Lead In group, 6 in Expansion 1, 5 in Expansion 2, and 20 in Expansion 3. It is worth noting that the data as submitted records the number of participants evaluated for these events, but a detailed breakdown of how many actually experienced specific side effects was not included in the structured results data provided. Regarding the recommended dose, the reported data shows that 4.5 grams per day was the dose of APR-246 identified from the Safety Lead In group for use in the expansion phase. Most participants completed the trial — 37 out of 40 — with 3 people not completing it (2 from Expansion 1 and 1 from Expansion 3), though the reasons 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05311176 · results posted 11 May 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — IMU-131 and pembrolizumab — given together to cancer patients. Seven people started the trial and all seven received at least one dose of the study drugs. None of the seven participants were recorded as having completed the trial. The study was measuring how often participants experienced unwanted medical events (called adverse events), including a specific category of immune-related side effects, as well as whether any participants' tumours shrank or disappeared in response to the treatment. The reported data shows that 6 out of 7 participants experienced at least one treatment-emergent adverse event — that is, an unwanted medical occurrence that happened after receiving the study drugs. One out of 7 participants experienced what the trial defined as an immune-related adverse event, which in this study meant a Grade 3 or higher reaction (a more serious level of reaction) involving a major organ that lasted longer than defined thresholds. When it came to tumour response, the reported data shows that 0 out of 7 participants had their tumours shrink or disappear to the degree required to count as an objective response. For the secondary outcomes — which looked at how long participants lived overall (overall survival), how long before their disease got worse (progression-free survival), and how long any response lasted (duration of response) — the reported data shows that no figures were provided for any of these measures, meaning those results were not reported 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT04288661 · results posted 27 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04288661) involved 60 people who had undergone a total gastrectomy (surgical removal of the stomach). Participants were split into two groups: 40 people who had a drain (a small tube placed near the surgical join to remove fluid) inserted after their operation, and 20 people who did not have a drain placed. The trial was measuring several immediate post-operative experiences, including pain levels, nausea and vomiting, when feeding and movement began, bowel activity, and how long people stayed in hospital. The reported data shows the following numbers across the two groups. For pain, 31 out of 40 people in the drain group reported high pain scores (above 5 on a 0–10 scale), compared with 3 out of 20 in the no-drain group. For nausea and vomiting in the first 5 days, 24 out of 40 in the drain group experienced this, compared with 5 out of 20 in the no-drain group. Delayed feeding (starting after day 3) was recorded in 15 out of 40 drain participants versus 2 out of 20 in the no-drain group. Delayed physical mobilisation was reported in 20 out of 40 drain participants compared with 2 out of 20 in the no-drain group. The reported average length of hospital stay was 7 days for the drain group and 5 days for the no-drain group. Bowel activity (such as passing wind or a bowel motion) was reported to begin on average at day 4 for the drain group and day 3 for the no-drain 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 ↗

  • NCT04082364 · results posted 22 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04082364) enrolled a total of 82 participants across five treatment groups. The largest group, called "Part A" or the "chemotherapy-free arm," included 48 participants who received a combination of two drugs — margetuximab and retifanlimab — without chemotherapy. The remaining 34 participants were spread across four "Part B" groups, which tested various combinations of margetuximab, chemotherapy, and other drugs, including a comparison group that received the standard drug trastuzumab with chemotherapy. The trial was measuring how often tumours shrank or disappeared (called the "objective response rate"), how long participants went without their disease getting worse, how long any response lasted, and how many participants experienced unwanted side effects. The reported data shows that in the chemotherapy-free Part A group, 52.1% of eligible participants had their tumour shrink or disappear. The median time before the disease got worse or participants passed away was reported as 9.8 months, and among those who did respond, the response lasted a median of 16.1 months. Regarding side effects in Part A, the reported data shows that out of 47 participants assessed, 47 experienced some form of adverse event (unwanted health change), 38 experienced a serious adverse event, 25 had an event that led to stopping treatment, 12 had a life-threatening event, and 8 deaths were recorded as adverse events — though the data does not break down the causes further. For side effects in the Part B groups, the data was not reported in the structured results provided. The reported data for the Part B groups shows that the proportion of participants whose tumours shrank or disappeared ranged from 62.5% in the trastuzumab-plus-chemotherapy comparison group up to 90.0% in the margetuximab-plus-chemotherapy group. The "disease control rate" — meaning the percentage of participants whose disease either shrank or stayed stable for at least three months — was reported as 83.3% in Part A, 87.5% in the trastuzumab comparison group, and 100% in each of the three other Part B groups. Median survival and response duration figures for the Part B groups 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02795988 · results posted 16 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02795988) tested an experimental treatment called IMU-131 in people with a specific type of cancer. The trial ran in stages: a Phase 1b safety-focused stage (14 participants across three dose levels of IMU-131 combined with chemotherapy), a Phase 2 stage that compared IMU-131 plus chemotherapy against chemotherapy alone (19 participants in the combination group and 17 in the chemotherapy-only group), and a Phase 2 Extension stage testing two higher doses of IMU-131 on its own (7 participants per dose group). The trial was measuring things like how long participants lived, how long their disease took to worsen, and how many participants experienced any medical events during the study. The reported data shows that in Phase 1b, all 14 participants across the three dose groups experienced at least one adverse event (an "adverse event" simply means any unwanted medical occurrence recorded during the study). In Phase 2, the reported median overall survival — that is, the midpoint survival time across participants — was 13.90 months for those in the IMU-131 plus chemotherapy group, compared with 8.31 months for those in the chemotherapy-only group. For how long it took for the disease to show signs of progressing (getting worse), the reported figures were 6.93 months for the IMU-131 plus chemotherapy group and 6.01 months for the chemotherapy-only group. The proportion of participants whose disease was recorded as being under control (either shrinking or stable) was reported as 77.8% in the combination group versus 71.4% in the chemotherapy-only group. In the Phase 2 Extension, the reported data shows that 7 out of 7 participants in the 100 μg IMU-131 group and 5 out of 7 in the 200 μg group experienced at least one adverse event. The disease control rate in the Extension was reported as 71.4% for the 100 μg group and 85.7% for the 200 μg group, while the time to disease progression was reported as 5.0 months and 5.5 months respectively. 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 ↗

  • NCT03615326 · results posted 17 March 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 738 participants in total. The global part of the trial included 350 people who received pembrolizumab (an immunotherapy medicine) added to standard chemotherapy, and 348 people who received standard chemotherapy alone. A separate smaller group based in Japan included 20 people in each of two similar treatment arms. The trial was measuring how long participants lived without their cancer growing (called progression-free survival), how long they lived overall (overall survival), how many had their tumours shrink or disappear (objective response rate), and how long those responses lasted. The reported data shows that, in the global group, participants receiving pembrolizumab plus standard chemotherapy had a median progression-free survival — meaning half of participants reached this point without their disease worsening — of 10.0 months, compared with 8.1 months in the standard chemotherapy group. Median overall survival was reported as 20.0 months for the pembrolizumab group and 16.8 months for the standard chemotherapy group. For the secondary outcomes, the reported data shows that 72.6% of participants in the pembrolizumab group had their tumours shrink or disappear, compared with 60.1% in the standard chemotherapy group. Among those who responded, the response lasted a median of 11.13 months in the pembrolizumab group and 9.5 months in the standard chemotherapy group. The Japan-specific group was not included in these outcome calculations, as specified in the trial's analysis plan. Regarding reported adverse events (unwanted medical occurrences during the study), 348 out of 350 participants in the global pembrolizumab group and 346 out of 346 treated participants in the global standard chemotherapy group experienced at least one adverse event. All 20 participants in each of the Japan groups also experienced at least one adverse event. Treatment was stopped due to an adverse event in 150 participants in the global pembrolizumab group, 136 in the global standard chemotherapy group, and 11 in each of the Japan 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03894618 · results posted 14 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03894618) tested an investigational drug called SL-279252 in 50 people in total across 15 different dose groups. Participants were given the drug at doses ranging from very low (0.0001 mg per kilogram of body weight) up to much higher levels (24.0 mg per kilogram), across two different dosing schedules (referred to as S1 and S2). All 50 participants who started the trial completed it. The trial was primarily measuring how many participants experienced certain unwanted side effects — called "treatment-emergent adverse events" — and whether any participants experienced what are known as "dose-limiting toxicities" (serious side effects severe enough to prevent further dose increases). It also looked at secondary measures including tumour response, the body's immune reaction to the drug (immunogenicity), and how much of the drug was detected in the blood. The reported data shows that across the 12 dose groups for which figures were provided, at least some participants in most groups experienced treatment-emergent adverse events — ranging from 1 participant in the lowest dose groups up to all 6 participants in the 3.0 mg/kg S1 group. Notably, the reported data shows that zero participants across all reported dose groups experienced a dose-limiting toxicity. Regarding tumour response, the data shows that only 1 participant (in the 1.0 mg/kg S1 group) met the criteria for an objective response; all other reported groups showed zero responses. Data for the three Schedule 2 dose groups and the 24.0 mg/kg S1 group were not reported for some of these measures. The recommended Phase 2 dose was listed as "not applicable" in the submitted data, meaning no figure was provided. For the immunogenicity measure — tracking how many participants developed antibodies against the drug — small numbers of participants across several dose groups tested positive, ranging from 0 to 3 per group. Blood concentration of the drug increased with higher doses, rising from 3.75 ng/mL at 0.001 mg/kg up to 320,000 ng/mL at 24.0 mg/kg; no blood level was reported for the lowest dose 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 ↗

  • NCT05883345 · results posted 11 March 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 1,490 participants, split into two groups: 1,346 people who did not have gastric (stomach) growths, and 144 people who did. The trial was measuring whether certain blood test results — specifically a protein ratio called the pepsinogen I/II ratio, and a hormone called Gastrin-17 — were different between the two groups. Not everyone who started the study completed it: 979 people in the no-growth group and 122 in the growth group finished. The reported data shows that the pepsinogen I/II ratio (a measure where a lower number is described as a worse result, on a scale from 0.2 to 19.1) averaged 9.9 in the group without stomach growths and 6.5 in the group with stomach growths. For the secondary measure, Gastrin-17 levels — a hormone measured in the blood in units called pmol/L — the reported data shows an average of 2.9 pmol/L in the group without stomach growths, compared to 11.8 pmol/L in the group with stomach growths. These numbers reflect what was observed and recorded across 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 ↗

  • NCT04032704 · results posted 10 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04032704) was split into two parts — Part A and Part B — and tested a drug (referred to as "LV") at different doses across a range of cancer types, grouped into separate cohorts. In Part A, 49 people took part across six cohorts, all receiving a dose of 2.5 mg/kg. In Part B, 156 people took part across twelve cohorts, receiving either 1.25 mg/kg or 1.0 mg/kg. The main thing the trial was measuring was the proportion of participants whose tumours shrank by a meaningful amount — called the "objective response rate" (ORR) — based on scans assessed using a standard set of rules known as RECIST v1.1. For one cohort in Part B that included people with prostate cancer, the trial also measured how many participants had a significant drop in a blood marker called PSA (a protein that can be elevated in prostate cancer). The reported data shows that in Part A, the percentage of participants whose tumours shrank enough to count as a response varied by cohort: 10% in Cohort 1, 0% in Cohort 2, 8% in Cohort 3, 14% in Cohort 4, 20% in Cohort 5, and 8% in Cohort 6. In Part B, the reported response rates also varied across cohorts: 6%, 13%, 11%, 0%, 18%, 14%, 0%, and 20% for the eight cohorts receiving 1.25 mg/kg, and 0%, 0%, 0%, and 50% for the four cohorts receiving 1.0 mg/kg (noting the 50% figure comes from a cohort of only 2 participants). For the prostate cancer cohort in Part B, 23% of participants were reported to have had a meaningful reduction in their PSA level. The reported data also shows that across all groups in both parts, every participant who started the trial was recorded as "not completed" — no additional detail about the reasons for this was provided 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 ↗

  • NCT03504397 · results posted 26 February 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03504397) enrolled 565 people in total — 283 in the group receiving zolbetuximab combined with a chemotherapy regimen called mFOLFOX6, and 282 in the group receiving a placebo combined with the same chemotherapy. The trial was measuring how long participants lived without their cancer getting worse (called progression-free survival), how long they survived overall, how their quality of life changed over time, and how many experienced a measurable shrinkage or disappearance of their tumour. The reported data shows that, for the main measure — the time until cancer worsened or death — the zolbetuximab group had a median (middle value) of 11.04 months, compared with 8.94 months in the placebo group. For overall survival, the reported median was 18.23 months in the zolbetuximab group and 15.57 months in the placebo group. Regarding tumour response, 48.1% of participants in the zolbetuximab group and 47.5% in the placebo group were reported to have had their tumour shrink or disappear. For quality-of-life measures, the time until a meaningful drop in physical functioning was reported as 9.89 months (zolbetuximab) versus 12.32 months (placebo), and the time until a meaningful drop in overall health status was 15.44 months versus 11.83 months respectively. The data for one quality-of-life measure related to abdominal pain and discomfort was not reported. It is also worth noting that relatively few participants were recorded as having completed the study — 26 in the zolbetuximab group and 17 in the placebo group — with the large majority not completing it, which is common in trials involving serious illnesses where participants may leave for various reasons including disease progression. 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 ↗

  • NCT04499924 · results posted 22 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04499924) enrolled 17 people in total — 8 in a group receiving a lower dose of paclitaxel (60 mg/m²) and 9 in a group receiving a higher dose (80 mg/m²). The trial was testing a combination of four medicines — tucatinib, trastuzumab, ramucirumab, and paclitaxel — and was focused on finding a suitable paclitaxel dose. The main things being tracked were serious side-effect events during the first treatment cycle (called dose-limiting toxicities), any medical events that appeared or worsened during treatment (called treatment-emergent adverse events), abnormal laboratory test results, changes in vital signs such as blood pressure and heart rate, changes in body weight, and whether doses needed to be adjusted. The reported data shows that in the lower-dose group, none of the 8 participants experienced a dose-limiting toxicity during the first cycle, while in the higher-dose group, 2 out of 9 participants did. All 8 participants in the lower-dose group and all 9 in the higher-dose group were reported to have experienced at least one treatment-emergent adverse event. Laboratory abnormalities and clinically significant vital sign changes were also recorded across both groups, with the higher-dose group generally showing these in a greater number of participants. The maximum average percentage decrease in body weight was reported as 0.34% in the lower-dose group and 6.21% in the higher-dose group. Dose modifications (such as holds or reductions) were common in both groups — reported in 7 out of 8 participants in the lower-dose group and 8 or 9 out of 9 in the higher-dose group, depending on which medicine was involved. Of the 17 who started the trial, only 3 (all in the lower-dose group) completed it; the remaining 14 did not complete the study, though the reasons 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 ↗

  • NCT04535414 · results posted 17 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04535414) enrolled people who carry a change in a gene called CDH1, which is linked to a hereditary risk of stomach cancer. Participants were randomly placed into one of two groups: 98 people followed the "Bethesda Protocol" (the investigational approach) and 97 followed the "Cambridge Method" (the standard comparison approach). Both groups also had a procedure called confocal endomicroscopy — a specialised camera technique used during a stomach examination. The trial was measuring how well each approach could detect early-stage stomach cancer cells, specifically a type called signet ring cell carcinoma, during an endoscopy (a camera examination of the stomach). The reported data shows that for the main (primary) measure — how often the cancer cells spotted during endoscopy matched what was later found when the stomach was surgically removed — a result of 1.0 (meaning 100%) was reported for the Bethesda Protocol group. No separate figure was reported for the Cambridge Method group for this measure. For one of the secondary measures, which looked at how often the endoscopy missed cancer cells that were later found in the removed stomach (sometimes called a "false negative" rate), the reported figure for the Bethesda Protocol group was 0.5 (or 50%); again, no figure was reported for the Cambridge Method group. For another secondary measure looking at the overall rate of cancer detected during endoscopy, the reported figures were 0.31 (31%) for the Bethesda Protocol group and 0.20 (20%) for the Cambridge Method group. The reported data also shows that 4 participants in the Bethesda Protocol group and 0 participants in the Cambridge Method group experienced non-serious adverse events (unexpected medical occurrences) during the trial. It is worth noting that several outcome measures only reported a figure for one of the two groups, meaning a full comparison between groups was not available 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 ↗

  • NCT04171141 · results posted 16 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04171141) tested an investigational drug called PF-07062119, either on its own at different dose levels or combined with one of two other drugs (PF-06801591 or bevacizumab). A total of 79 people took part across 16 different dose groups. The trial was an early-phase study, so its main focus was on closely monitoring participants for certain pre-defined serious medical events (called "dose-limiting toxicities," or DLTs — meaning significant harmful reactions that could signal a dose is too high) and tracking all medical events that occurred during the study period. The reported data shows that, when looking at DLTs during the first treatment cycle, most dose groups recorded zero participants with these events. Two groups — those receiving 800 µg and 1,600 µg of PF-07062119 alone — each had 2 participants with a DLT recorded, and two other groups had 1 participant each. For the groups receiving the drug in combination, the data for several sub-groups was not reported in the submitted results. When researchers tracked all medical events that arose during treatment (regardless of whether they were thought to be related to the study drug), the reported data shows that every participant who started the trial experienced at least one such event. Serious abnormalities in blood or chemistry test results (graded as severe or life-threatening on a standard medical scale) were reported in small numbers across various dose groups — ranging from 0 to 3 participants per group for blood-related abnormalities, and 0 to 1 participant per group for chemistry-related abnormalities. Results for the secondary outcome measures (such as how the drug moved through the body) were only partially included 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 ↗

  • NCT03980925 · results posted 13 January 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 37 participants, all of whom received a combination of nivolumab (an immunotherapy drug) and platinum-based chemotherapy. The trial had two phases: an induction phase (an initial, more intensive treatment period), in which all 37 participants started and completed, and a maintenance phase (an ongoing, follow-up treatment period), in which 24 participants started and completed. The main thing the trial was measuring was how many participants were still alive 12 months after starting treatment. The reported data shows that 54.1% of participants were alive at the 12-month mark. For the secondary measurements — things the trial also tracked but were not the main focus — the reported data shows that 56.8% of participants had their tumour shrink or disappear (what researchers call an "overall response"). The reported figures for the percentage of participants whose disease had not progressed (worsened) were 21.6% and 8.1% (these appear to correspond to two different time points, though the specific time points were not clearly labelled in the reported data). The median overall survival — meaning the point at which half of participants had passed away and half were still alive — was reported as 13.9 months. Among participants who had an elevated level of a particular protein called enolase at the start of the trial, 52.4% were reported to have had a biochemical response to treatment. The trial also recorded side effects; the most commonly reported figures ranged from 60.5% down to 15.8% of participants experiencing various individual side effects, though the specific nature of each side effect was 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 ↗

  • NCT03150810 · results posted 20 December 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03150810) enrolled a total of 139 people across multiple groups. Participants were tested with two drugs given together — pamiparib and temozolomide (TMZ) — across a range of doses and dosing schedules. The trial had two main phases: a "dose escalation" phase (where researchers tested different dose levels and schedules to find an appropriate dose) and a "dose expansion" phase (where specific cancer types were studied further, including gastric cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, and other cancers with a particular genetic feature called HRD+). The reported data shows that no participants were recorded as having completed the trial across any group, with all participants recorded under "not completed." The reported data shows that for the primary outcome of dose-limiting toxicities (serious side effects observed during the initial dosing period), 0 out of the relevant participants experienced these events across most dose groups, while 2 out of 3 participants in the 100 mg (days 1–7) group and 2 out of 3 in the 120 mg (days 1–7) group were reported to have experienced them. For adverse events (unwanted medical occurrences) more broadly, the reported numbers suggest that virtually all participants across every group experienced at least one adverse event. Regarding the objective response rate — that is, the percentage of participants whose tumours shrank or disappeared by a meaningful amount — the reported figures varied widely by group: 0% in several groups, around 17–25% in some dose escalation groups, 0% in the gastric cancer expansion group, 50% in the ovarian cancer group (4 participants), 15% in the small cell lung cancer group, and 100% in the triple-negative breast cancer group (only 1 participant). The data for the "Other HRD+ Cancers" expansion group's response rate was not reported in the submitted results. For the secondary outcomes, blood concentration levels of pamiparib were also measured and reported at various timepoints, but a detailed breakdown by individual dose group was not provided 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 ↗

  • NCT05071053 · results posted 5 December 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT05071053) enrolled 35 participants, all of whom received a combination of two drugs: tusamitamab ravtansine and ramucirumab. The trial was looking at two main things: whether certain serious side effects (called dose-limiting toxicities, or DLTs — meaning side effects severe enough to limit how much of the drug could be given) occurred in the first two cycles of treatment, and how many participants' tumours shrank or disappeared, known as the objective response rate (ORR). None of the 35 participants were recorded as having completed the study. The reported data shows that zero participants experienced a dose-limiting toxicity during the first two cycles of treatment. For the objective response rate, the reported figure was 14.3%, meaning roughly 1 in 7 participants had their tumour recorded as having shrunk or disappeared by a defined amount. The reported data also shows that 62.9% of participants achieved what is called "disease control" — meaning their tumour either shrank or remained stable rather than growing. The median time before the disease progressed or a participant died (called progression-free survival) was reported as approximately 3.78 months. For how long responses lasted in those who did respond (duration of response), the data was not reported. Regarding broader side effects, all 35 participants were reported to have experienced at least one treatment-emergent adverse event (an untoward medical event that occurred during the treatment period), and 15 participants experienced a serious adverse 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT04508140 · results posted 29 November 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04508140) enrolled 18 people across two groups — 11 participants in Cohort A and 7 in Cohort B. The trial was testing a combination of two treatments (BO-112, given directly into liver tumours, and pembrolizumab, given through a drip) in people with cancer that had spread to the liver. The trial measured how many participants' tumours shrank or responded to treatment, how long participants went without their disease getting worse, and how many experienced serious side effects. The reported data shows that across both Cohort A and Cohort B, zero participants were recorded as having a tumour response (meaning no shrinkage was recorded under either of the two measurement systems used). Similarly, zero participants were reported as achieving disease control — which includes tumours shrinking, disappearing, or staying stable. The reported data shows that the average time before disease progressed was approximately 1.35 months in Cohort A and 1.38 months in Cohort B. Regarding serious side effects, 4 participants in Cohort A and 4 participants in Cohort B were reported to have experienced treatment-related side effects rated as severe (Grade 3 or higher on a standard medical scale). It is also worth noting that the trial records show zero participants were recorded as having formally "completed" the study in either group, though the data does not explain the reasons further. 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 ↗

  • NCT04711135 · results posted 27 November 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 11 adolescent participants in total — 4 with a type of tumour called a gastroenteropancreatic neuroendocrine tumour (GEP-NET) and 7 with tumours called pheochromocytoma or paraganglioma (PPGL). The trial was looking at a treatment called Lutathera, which delivers radiation directly to tumour cells. The study measured how much radiation was absorbed by key organs (the kidneys and bone marrow), and tracked any unwanted side effects or abnormal lab results that occurred during and after treatment. The reported data shows that radiation doses absorbed by the kidneys were 0.71 Gy/GBq in the GEP-NET group and 0.82 Gy/GBq in the PPGL group (Gy/GBq is simply a unit expressing how much radiation energy each organ absorbed relative to the dose given). For bone marrow, the reported figures were 0.024 Gy/GBq (GEP-NET) and 0.028 Gy/GBq (PPGL). The reported data also shows that after the first dose of Lutathera, adverse events (unwanted health changes that were recorded and monitored) occurred in all 4 GEP-NET participants and in 6 of the 7 PPGL participants. Over the full treatment period and short-term follow-up, adverse events were recorded for all 4 GEP-NET participants and all 7 PPGL participants. Regarding the probability of the kidney radiation dose exceeding a pre-set safety threshold, a figure of 20% was reported; for bone marrow, that figure was 0%. Results for the long-term follow-up (up to five years after treatment) were not reported in the data submitted. The reported data shows that a measure of how the drug moved through the body (called AUClast — broadly, the total amount of drug the body was exposed to over time) was 41 ng·h/mL as observed in participants, compared with 32.34 ng·h/mL as predicted by a mathematical model. The trial was small, with only 11 participants across both tumour types, so the numbers reflect a limited group of adolescents in a specific study setting. 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 ↗

  • NCT04740164 · results posted 6 November 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in a group that used a device called the LMA Gastro (a specialised airway device placed in the throat) and 33 in a group that received standard care using a nasal cannula (a small tube that sits under the nose to deliver oxygen). The trial was measuring what happened to people's oxygen levels and airway management during a procedure called ERCP, which is a procedure that examines the digestive tract. Of those who started, 26 people in the LMA Gastro group and 30 in the standard care group completed the trial. The reported data shows that for the main thing being measured — how many people experienced a drop in blood oxygen below 90% (a level considered low) — 0 people in the LMA Gastro group had this occur, compared with 3 people in the standard care group. The reported data also shows that for one secondary measure, 5 people in the LMA Gastro group needed extra steps taken to manage their airway during the procedure, compared with 19 in the standard care group. For adverse events (unwanted occurrences during or shortly after the procedure), 24 events were recorded in the LMA Gastro group compared with 3 in the standard care group — though the data does not break down what those events were. Regarding time, the reported figures show that the overall anaesthesia time was around 75 minutes for the LMA Gastro group and about 63 minutes for the standard care group, while the procedure itself took roughly 33 minutes in the LMA Gastro group and about 46 minutes in the standard 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 ↗

  • NCT04852679 · results posted 1 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04852679) enrolled 43 participants, all of whom received a medicine called Lanreotide Autogel 120 mg. The trial had one main treatment period of 24 weeks, followed by a shorter independent injection period for a small subset of participants. The main thing the trial set out to measure was the "clinical benefit rate" — that is, the proportion of participants whose tumours either shrank, disappeared completely, or stayed stable (did not grow significantly) by the 24-week mark, as assessed by an independent review team looking at scan results. The reported data shows that at the 24-week mark, 62.79% of participants met the criteria for clinical benefit (meaning their tumours had either shrunk, disappeared, or remained stable). At the 48-week mark, the reported clinical benefit rate was 58.1%. When looking at the proportion of participants who were alive and whose disease had not progressed, the reported data shows 77.4% at 24 weeks and 59.0% at 48 weeks. For several other secondary measures — including overall survival, progression-free survival, and time to progression — the specific numerical results were not reported in the submitted data, 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT04078152 · results posted 4 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04078152) enrolled 163 people across three groups. One hundred participants were in Cohort 1 (continuing treatment with a medicine called durvalumab), 25 were in Cohort 2 (restarting durvalumab after a break), and 38 were in Cohort 3 (not restarting durvalumab). The trial was looking at unwanted medical events (called adverse events) that occurred during the study, as well as how many people were still alive and, for those who restarted durvalumab, whether their cancer showed any measurable shrinkage. The reported data shows that in Cohort 1, 85 out of 100 participants experienced some kind of unwanted medical event, and 23 of those 100 experienced a serious unwanted medical event — meaning one that was life-threatening, required hospitalisation, or caused significant harm. In Cohort 2, only 1 participant had an unwanted medical event and none had a serious one, while in Cohort 3 no unwanted medical events were recorded in the submitted data. Regarding tumour response in Cohort 2 (those who restarted durvalumab), the reported response rate was 0%, meaning none of the participants in that group had a recorded shrinkage of their cancer that met the study's criteria. The duration of response figure for Cohort 2 was listed as not applicable, which is consistent with no responses being recorded. The reported data also shows that at the time of analysis, 90 out of 100 participants in Cohort 1, 23 out of 25 in Cohort 2, and 26 out of 38 in Cohort 3 were recorded as still alive. It is worth noting that the data shows zero participants were recorded as having "completed" the study across all three groups, which the trial records attribute to all participants either withdrawing or the study ending — no further detail on this was provided 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 ↗

  • NCT02443324 · results posted 31 July 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people in total across seven groups (called cohorts A, A1, A2, B, C, D, and E). The trial was an early-phase study measuring, firstly, how often participants experienced serious side effects from the study drug combination severe enough to limit the dose (called "dose-limiting toxicities"), and secondly, how tumours responded over time — including whether they shrank, stayed stable, or grew. The reported data shows that in the dose-finding phase (Phase 1a), 1 out of the participants in Cohort A experienced a dose-limiting toxicity, while 0 out of the participants in Cohort C did. When looking at tumour responses across the broader study, the percentage of participants whose tumours shrank meaningfully (either completely or partially) ranged from about 4% in Cohort A1 up to about 42% in Cohort E, with the other cohorts falling in between. The percentage of participants whose tumours either shrank or remained stable (known as the disease control rate) ranged from about 39% in Cohort A1 to about 85% in both Cohort C and Cohort E. Among those whose tumours did respond, the reported time until that first response ranged from roughly 1.4 to 2.8 months depending on the cohort. The length of time participants went without their disease progressing (progression-free survival) ranged from about 1.6 months in Cohort A1 to about 9.7 months in Cohort C. Duration of response figures were only reported for some cohorts (6.7 months for Cohort A and B combined, 6.0 months for Cohort A1, and 8.3 months for Cohort D); for the remaining cohorts this figure was 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT06136897 · results posted 25 June 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT06136897) enrolled 35 people who received a combination of two medicines — pertuzumab and trastuzumab. These are targeted treatments given to people whose cancers carry a specific genetic change (HER2 mutation or amplification). The trial was measuring how often tumours shrank or disappeared (called the "objective response rate"), as well as how long people went without their cancer getting worse (called "progression-free survival"). Of the 35 who started, 32 were confirmed eligible and treated, and 25 had their mutation status confirmed during the study. The reported data shows that, among the participants assessed, 12% had their tumour shrink or disappear in response to the treatment. For the survival-related measures, the reported data shows that 25.3% of participants went six months without their disease getting worse or dying. The middle-point figure (median) for how long participants went without their disease progressing was reported as 3.3 months — meaning roughly half of participants reached that point before their disease progressed or they passed away, and half did so after. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study in the formal sense, which likely reflects how the trial's completion was defined rather than meaning all participants dropped out — but this detail was not further explained 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 ↗

  • NCT04604132 · results posted 4 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04604132) enrolled 47 people in total across five groups. The trial was testing a drug called derazantinib — alone in different doses and dosing schedules, and in combination with two other drugs (paclitaxel and ramucirumab) — in people with a type of stomach cancer called gastric adenocarcinoma that had certain changes (fusions, amplifications, or mutations) in genes known as FGFR1, FGFR2, or FGFR3. The trial was looking at whether tumours shrank (called objective response rate, or ORR — meaning the percentage of people whose tumour meaningfully reduced in size), whether disease stayed stable or didn't worsen for at least four months, and what dose of derazantinib to use alongside the other two drugs in future studies. The reported data shows that in the groups receiving derazantinib on its own (Substudy 1), the ORR — that is, the percentage of people whose tumour shrank by a meaningful amount — was reported as 0% across all three patient groups. For the group measured on whether they were alive and free of disease progression at four months (Cohort 1.3, taking derazantinib 200 mg twice daily), the reported figure was 7.7%, meaning roughly 1 in 13 participants met that measure. The median time without disease progression in that same group was reported as 1.7 months. When looking at disease control rate — which includes people whose disease shrank or stayed stable — the reported figures were 30.8%, 25.0%, and 15.4% for the three individual groups, and 23.5% when those groups were combined. For the combination treatment part of the trial (Substudy 2), the reported data shows that 200 mg once daily was determined as the recommended dose of derazantinib to take forward with the other two drugs in any future phase 2 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT02052778 · results posted 20 March 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02052778) enrolled participants across three stages: a dose-escalation phase (Phase 1), a dose-expansion phase (also Phase 1), and a Phase 2 portion. In the dose-escalation stage, 96 people took part across 14 different dose groups, testing a drug called TAS-120 (also known as futibatinib) at varying amounts given either every other day or once daily. The dose-expansion stage enrolled a further 201 people across six cohorts and two sub-cohorts, and the Phase 2 stage enrolled 120 people (of whom 103 received treatment). Across all stages, the trial was measuring things such as the highest dose that could be given without too many serious side effects, the best dose to carry forward into later testing, and how many participants' tumours shrank or disappeared according to standard imaging criteria. The reported data shows that, in the once-daily dosing arm of the dose-escalation phase, the highest tolerable dose (known as the Maximum Tolerated Dose, or MTD — meaning the highest amount where fewer than one in three participants experienced serious pre-defined reactions in the first treatment cycle) was reported as 20 mg. This 20 mg daily dose was also reported as the recommended dose to take forward into Phase 2 testing. For the every-other-day dosing arm, the reported data shows that an MTD figure was not determined (recorded as "NA" — not available). The reported data for the percentage of participants whose tumours shrank or disappeared (called "objective response") across the dose-expansion cohorts and the Phase 2 portion was not fully included in the data provided to summarise here, so those specific figures cannot be 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 ↗ · Linked publication on PubMed ↗

  • NCT04144140 · results posted 7 March 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04144140) tested a drug called E7766, given directly into the bladder, in people with a type of bladder cancer. The trial had two parts: a dose escalation part, where different amounts of the drug were tested to find a safe starting range, and a dose expansion part, where a chosen dose would be tested in a larger group. In the dose escalation part, 24 people took part across six dose levels (75, 150, 300, 600, 780, and 1,000 micrograms). No participants were enrolled in the dose expansion part during the period covered by these results. The reported data shows that across all dose levels in the escalation part, every participant who started the study experienced at least one treatment-emergent adverse event — that is, a health event that occurred after taking the drug. Regarding what the trial called "dose-limiting toxicities" (DLTs — pre-defined side effects serious enough to limit how much of the drug could be given), the reported data shows zero DLTs at the 75, 150, and 300 microgram dose levels. At the 600 microgram level, 2 out of 11 participants had a DLT, and at the 780 microgram level, 1 out of 6 participants had a DLT. No DLT data was reported for the 1,000 microgram group. The expansion part outcomes — including tumour response rates and how long any response lasted — were not reported, as no participants were enrolled in that part. 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 ↗

  • NCT03382600 · results posted 1 December 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03382600) enrolled 100 people across two groups. Fifty-four participants received a combination of pembrolizumab, oxaliplatin, and a drug called TS-1 (Cohort 1), while 46 participants received pembrolizumab, cisplatin, and TS-1 (Cohort 2). The trial was measuring how tumours responded to these treatment combinations, based on medical imaging assessed by an independent review team. No participants were recorded as having formally "completed" the study, meaning all 100 either stopped early or were still in follow-up at the time the data was submitted. The reported data shows that the main thing being measured — the proportion of participants whose tumours shrank to a meaningful degree (called the objective response rate, or ORR) — was 72.2% in Cohort 1 and 80.4% in Cohort 2. A broader measure called the disease control rate — which also counted participants whose tumours stayed stable and did not grow significantly — was reported as 96.3% in Cohort 1 and 97.8% in Cohort 2. For those participants whose tumours did respond, the reported data shows the response lasted a median (middle value in a range) of 10.6 months in Cohort 1 and 9.5 months in Cohort 2. These same figures were reported using two different measuring systems (RECIST 1.1 and iRECIST), and the numbers were identical under both. 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 ↗

  • NCT01522768 · results posted 1 November 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people with a form of stomach or oesophageal cancer that had spread (metastatic) and carried a specific protein marker called HER2. All 42 participants completed the study. The trial was looking at how participants responded to a combination of two medicines — afatinib and paclitaxel — by tracking whether their cancer showed signs of shrinking, staying stable, or continuing to grow over a four-month period. The reported data shows that out of the 42 participants, 4 had a complete response (meaning no detectable cancer was found on scans), 18 had a partial response (meaning the cancer shrank but did not disappear), 12 had stable disease (meaning the cancer did not grow significantly), and 8 did not fall into any of those categories. The trial defined its main measure of interest — called "overall clinical benefit" — as the combined count of people whose cancer either disappeared, shrank, or stayed stable at the four-month mark. The reported data also shows that all 42 participants were assessed for side effects and adverse events, though the specific details of those events were not included in the structured results 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03675737 · results posted 12 October 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03675737) enrolled 790 people in the pembrolizumab-plus-chemotherapy group and 789 people in the placebo-plus-chemotherapy group — a total of 1,579 participants. The trial was studying treatments for gastric (stomach) or gastro-oesophageal junction cancer. It measured two main things: how long participants lived overall (called "overall survival"), and how long they went before their cancer grew or they passed away (called "progression-free survival"). Results were also looked at separately for people whose tumours had higher levels of a protein marker called PD-L1 — a feature of tumour cells that researchers use to group patients. The reported data shows that, across all participants, the median overall survival — that is, the point at which half the participants in each group had passed away — was 12.9 months in the pembrolizumab-plus-chemotherapy group compared with 11.5 months in the placebo-plus-chemotherapy group. When looking only at participants whose tumours had a PD-L1 score of 1 or above, the reported median overall survival figures were 13.0 months versus 11.4 months. For those with a higher PD-L1 score of 10 or above, the reported figures were 15.7 months versus 11.8 months. For the secondary measure of progression-free survival (time before cancer grew or death), the reported median was 6.9 months in the pembrolizumab group versus 5.6 months in the placebo group across all participants, with the same figures reported for the PD-L1 score ≥1 subgroup. In the PD-L1 score ≥10 subgroup, the reported progression-free survival figures were 8.1 months versus 5.6 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03427814 · results posted 21 September 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03427814) enrolled 136 people in total — 71 received the study drug pamiparib and 65 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how long participants went without their disease getting worse, which researchers call "progression-free survival." A range of other outcomes were also tracked, including how long participants lived overall, how many showed a measurable reduction in their disease, and how long any such response lasted. The reported data shows that, on average, participants in the pamiparib group went 3.7 months before their disease progressed or they died, compared with 2.1 months in the placebo group. For overall survival — meaning how long participants lived from the start of the trial — the pamiparib group averaged 10.2 months and the placebo group averaged 12.0 months. Around 7.7% of people in the pamiparib group showed a measurable response to treatment (their disease shrank or disappeared), compared with 6.3% in the placebo group. Among those who did respond in the pamiparib group, the response lasted an average of 3.6 months; this figure was not reported for the placebo group. The time from the start of the trial until a second round of follow-up cancer treatment was nearly identical between the two groups — 9.8 months for pamiparib and 9.7 months for placebo. It is worth noting that the data shows zero participants were recorded as having "completed" the study in either group, which may reflect how trial completion was defined rather than meaning no one finished their assigned 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 ↗

  • NCT04724291 · results posted 11 September 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 43 participants, all of whom underwent both a Magnetically Controlled Capsule Endoscopy (MCCE — a swallowable camera pill guided by a magnet from outside the body) and a standard camera examination of the stomach called an EGD (where a flexible tube with a camera is passed down the throat). Forty participants completed the study, and three did not complete it. The trial was measuring whether the capsule camera could clearly photograph key areas of the stomach and oesophagus, and how its findings compared to those of the standard EGD procedure. The reported data shows that, of the 40 participants whose MCCE results were reviewed, the number of participants for whom each of the 12 pre-specified stomach and oesophageal landmarks was successfully photographed ranged from 31 to 39 participants, depending on the specific landmark. For the comparison to EGD in detecting stomach findings, the reported data shows 35 participants had results categorised one way and 5 another way, though the specific categories for those two figures were not spelled out in the submitted data. For the secondary outcome on patient preference, 31 participants reported preferring the capsule procedure, 3 preferred the EGD, 5 had no preference, and 1 participant's preference was not reported. Regarding the tracking of any unwanted events over 30 days, the reported data shows 39 participants had no adverse events recorded, 1 participant had an event noted, and no further breakdown was provided 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 ↗

  • NCT04208958 · results posted 29 August 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people with one of three types of advanced cancer: stomach/gastro-oesophageal junction (GEJ) cancer (20 people), melanoma (a type of skin cancer, 20 people), or a form of colorectal (bowel) cancer known as MSS (14 people). Two participants did not end up receiving the treatment. All participants received a combination of an experimental product called VE800 — which is designed to work through the gut microbiome (the community of bacteria living in the digestive system) — together with nivolumab, a type of cancer immunotherapy drug. The trial was measuring how many people experienced side effects, as well as whether and how much participants' tumours responded to the treatment. The reported data shows that out of 54 treated participants, 47 experienced at least one adverse event (an unwanted health event recorded during the trial) — 16 out of 20 in the melanoma group, 19 out of 20 in the stomach/GEJ group, and 12 out of 14 in the bowel cancer group. Regarding tumour response, the reported data shows that only 1 participant out of the total group had what is called a "partial response" (meaning their tumour shrank by at least 30%), while no participants had a "complete response" (full disappearance of detectable tumour). For that one participant who responded, the response lasted 5.6 months according to the reported data. The reported median progression-free survival — that is, the middle-point estimate of how long participants went before their disease worsened or they passed away — was approximately 1.8 to 1.9 months across the different cancer groups. The reported data also shows that across all participants, 3 had a partial response or stable disease (where the tumour did not grow or shrink significantly) in the melanoma group, 9 in the stomach/GEJ group, and 3 in the bowel cancer group, giving a combined disease control figure of 15 participants. It is worth noting that the trial recorded zero participants as having formally "completed" the study, which the data does not explain further. 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 ↗

  • NCT02935634 · results posted 9 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02935634) enrolled a total of 190 participants across six treatment groups, testing different combinations of cancer medicines — including nivolumab, ipilimumab, BMS-986016 (relatlimab), BMS-986205, rucaparib, and combinations of these — in people with advanced cancers. The trial used two separate pathways (called "Track 1" and "Track 2"), and participants could move between tracks depending on how their disease responded. The trial was primarily measuring how many participants' tumours shrank or disappeared (called the objective response rate), how long that response lasted, and how many participants remained free of disease progression at 24 weeks. The reported data shows that the proportion of participants whose tumours shrank or disappeared varied across the treatment groups and tracks. In Track 1, the reported response rates ranged from 0% (in the nivolumab + rucaparib and ipilimumab + rucaparib groups) up to 16.7% in the nivolumab + ipilimumab + rucaparib group. In Track 2, response rates ranged from 0% in several groups up to 8.7% in the nivolumab + ipilimumab group. For how long responses lasted, the reported data was only available for some groups — for example, in Track 1, the nivolumab + ipilimumab group reported a median response duration of 156 weeks, while in Track 2 the nivolumab + ipilimumab group reported approximately 14.7 weeks and the nivolumab + BMS-986016 group approximately 16.9 weeks; duration data was not reported for several other groups. For the 24-week progression-free survival rate, figures were only reported for two groups: Track 1 nivolumab + BMS-986205 (0.24, meaning about 24 in every 100 participants) and Track 2 nivolumab + BMS-986016 (0.17, meaning about 17 in every 100 participants); this figure was not reported for the remaining groups. The reported data also shows that adverse events (unintended medical occurrences during the trial) and serious adverse events were recorded across all groups, with numbers reflecting the size of each group. Thyroid and liver test abnormalities were also measured and reported across groups, with varying numbers of participants affected in each. The raw counts for these findings are listed in the submitted results, but no further detail about the nature or severity breakdown was included 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.

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  • NCT03918499 · results posted 23 March 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03918499) enrolled 9 participants, all of whom completed the study. All 9 received the same combination treatment made up of three medicines: Pembrolizumab, Cyclophosphamide, and IRX-2. The trial was measuring how long participants went without their cancer getting worse (called progression-free survival), how long they lived overall, and whether their tumours shrank or disappeared in response to treatment. The reported data shows that the median progression-free survival — that is, the midpoint time before the cancer was recorded as getting worse or participants died — was 1.1 months. The median overall survival, meaning the midpoint time from the start of treatment until death from any cause, was reported as 2.9 months. For the overall response measure, which counted participants whose tumours either completely disappeared or shrank by 30% or more, the reported number was 0 out of 9 participants. It is worth noting that with only 9 participants, this was a very small study, and no comparison group was included in the data reported. The reported data does not include any information about side effects or other safety findings — that information was not submitted as part of the structured results on ClinicalTrials.gov, so it 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 ↗

  • NCT03343301 · results posted 27 January 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03343301) enrolled 12 people in total — 3 in a group receiving a lower dose of bemarituzumab (6 mg/kg) combined with a chemotherapy regimen called mFOLFOX6, and 9 in a group receiving a higher dose (15 mg/kg) combined with the same chemotherapy. No participants were recorded as having completed the study. The trial was primarily measuring two things: how many participants experienced side effects judged to be related to the treatment and rated as at least "moderate" in severity (Grade 2 or above on a standard scale), and how many experienced what are called "dose-limiting toxicities" — side effects serious enough that they would prevent the dose from being increased further. The reported data shows that, for the main outcomes, 1 out of 3 participants in the lower-dose group and 4 out of 9 in the higher-dose group had treatment-related side effects rated moderate or worse (Grade 2 or above). Neither group had any participants recorded as experiencing a dose-limiting toxicity — that figure was 0 out of 3 and 0 out of 9 respectively. For the secondary (additional) outcomes, all 3 participants in the lower-dose group and all 9 in the higher-dose group experienced at least one treatment-emergent adverse event (any side effect arising during or shortly after treatment). The trial also measured how much of the drug was present in participants' blood at various points; for example, the peak blood concentration of bemarituzumab was reported as 119 µg/mL in the lower-dose group and 329 µg/mL in the higher-dose group during one measurement period. 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 ↗

  • NCT03126110 · results posted 28 December 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03126110) tested an investigational drug called INCAGN01876 — either alone, or combined with other cancer immunotherapy drugs (nivolumab and/or ipilimumab) — in people with advanced solid tumours. The trial ran in two stages: a Phase 1 safety and dose-finding stage, and a Phase 2 stage looking at how tumours responded. In Phase 1, a total of 51 participants were enrolled across 11 different dosing groups. In Phase 2, 94 participants were enrolled across six groups, covering cancer types including stomach cancer (gastric cancer), head and neck cancer (SCCHN), cervical cancer (CC), and groups of patients whose cancers had previously stopped responding to a certain type of immunotherapy (called PD-1/PD-L1 treatments). The reported data shows that in Phase 1, the primary outcome measured was how many participants experienced a treatment-emergent adverse event — that is, any new or worsening medical event after starting the study drug. All participants in every Phase 1 group recorded at least one such event, with numbers matching the group sizes (for example, all 4 participants in some groups, all 5 or 6 in others). For the secondary outcome in Phase 1 — the proportion of participants whose tumours shrank to a defined degree (called the objective response rate, or ORR) — most groups reported 0%, with some groups reporting 25% (1 in 4 participants) and one group reporting 20% (1 in 5 participants). In Phase 2, the primary outcome was also the ORR. The reported data shows 0.0% in the PD-1/PD-L1 previously-treated group receiving INCAGN01876 plus ipilimumab, 0.0% in the stomach cancer group, 23.9% in the head and neck cancer group, 16.7% in the cervical cancer group, and 0.0% in both the PD-1/PD-L1 previously-treated group receiving INCAGN01876 plus nivolumab and the biopsy 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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  • NCT02310464 · results posted 3 October 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total across four groups. The first three groups (4, 3, and 4 participants respectively) received different dose levels of the study treatment in a step-by-step dose-finding phase, while a fourth "expansion" group of 14 participants followed. Only one participant across all groups completed the study as planned; the rest did not complete it, though the reasons are not detailed in the reported data. The trial was measuring two main things: first, whether participants experienced any unwanted side effects or health events after starting the treatment (called "treatment-emergent adverse events"); and second, how the body responded by producing certain proteins called antibodies — specifically antibodies that target a substance known as Globo H. The reported data shows that, looking at side effects or health events, 1 out of 4 participants in Cohort 1, 0 out of 3 in Cohort 2, 3 out of 4 in Cohort 3, and 3 out of 14 in the Expansion Cohort experienced these kinds of events. A separate set of figures shows 4, 3, 4, and 13 participants respectively recorded across a related count — though the distinction between these two sets of numbers is not fully explained in the submitted data. For the antibody measurements, the reported data shows the highest recorded antibody levels (in micrograms per millilitre, a standard unit of concentration) for each group. For one type of antibody (IgM), the peak figures were 4.60, 2.05, 3.17, and 13.92 across the four groups. For a second type (IgG), the figures were 5.01, 1.00, 2.19, and 9.47 across the same 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 ↗

  • NCT02513784 · results posted 22 September 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02513784) enrolled 20 people in total, split evenly into two groups of 10. One group used an antibacterial mouthwash, while the other group received no intervention. All 20 participants completed the study — none dropped out. The trial was set up to measure levels of a specific bacterium called *Fusobacterium nucleatum* (a type of bacteria found in the mouth and gut) — first in saliva samples, and then in the oesophagus (the food pipe connecting the mouth to the stomach). The researchers were looking at whether there were any differences in the amount of this bacterium between the two groups, and whether it changed within individuals over the course of the study. The reported data shows that two primary outcome measures were pre-specified: the change in *F. nucleatum* levels in saliva within each person, and the difference in *F. nucleatum* levels in the oesophagus between the mouthwash group and the no-intervention group. However, no numerical results were submitted for either of these outcome measures in the data reported to ClinicalTrials.gov. In other words, while the trial was completed and participant numbers were recorded, the actual measurement figures for both primary outcomes were not reported in the structured results available. 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 ↗

  • NCT05091528 · results posted 18 August 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT05091528) tested a drug called SBT6050 in combination with other cancer medicines across four planned treatment groups. However, the trial enrolled only two participants in total — one in the group receiving SBT6050 with T-DXd (at a dose of 6.4 mg/kg) and one in the group receiving SBT6050 with Tucatinib and Trastuzumab. Neither participant completed the study. The trial was designed to look at safety-related events, unusual laboratory test results, and whether tumours showed any response to treatment. The reported data shows that, among the two participants in the dose-escalation phase, neither experienced what the trial defined as a "dose limiting toxicity" — meaning a side effect severe enough to limit the dose — and neither had laboratory test abnormalities flagged as clinically significant. Both participants did experience at least one "treatment-emergent adverse event," which simply means any health event that occurred after starting treatment. For the secondary measure looking at tumour response (whether tumours shrank or disappeared), the reported data shows one out of one participant in the SBT6050 plus T-DXd group met the response criteria, while zero out of one participant in the SBT6050 plus Tucatinib and Trastuzumab group did. The outcome measures relating to the dose-expansion phase of the trial have no data reported, likely because those phases were not reached given the very small number of participants enrolled. It is important to note that with only two people enrolled across all groups, the numbers above are extremely limited and cannot be used to draw any broader conclusions about these treatment combinations. 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 ↗

  • NCT02830594 · results posted 30 June 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom completed the study. The trial looked at the combination of a drug called pembrolizumab (an immunotherapy) and radiation therapy (RT). It was primarily measuring how certain biological markers in tumour tissue changed between before and after treatment — specifically, two markers related to a protein called PD-L1 (known as CPS and TPS) and a type of immune cell called myeloid-derived suppressor cells (MDSCs) — all measured in tumour sites that were *not* directly targeted by the radiation. The reported data shows that, on average, CPS (a measure of PD-L1 protein in both tumour and surrounding immune cells) changed by a factor of 3.9 — meaning it was roughly 3.9 times different after treatment compared to before. MDSCs (a type of cell that can influence the immune system) showed a similar pattern, with a reported fold change of 3.6. TPS (a measure of PD-L1 in tumour cells only) showed a much smaller change, with a reported fold change of 0.3. For the secondary outcomes, the reported data shows that 9 participants experienced treatment-related unwanted medical events (adverse events), with specific numbers of participants experiencing various individual events ranging from 4 participants down to 1, though the exact nature of each individual event was not detailed in the data provided. The overall response rate — meaning the proportion of participants whose tumours shrank or disappeared based on standard imaging measurements — was reported as approximately 28.6%. The median progression-free survival (the middle-point estimate of how long participants went without their disease worsening or death occurring) was reported as 1.3 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 ↗

  • NCT03694522 · results posted 24 May 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03694522) enrolled 155 people in total — 77 in the group that received bemarituzumab alongside a chemotherapy regimen called mFOLFOX6, and 78 in the group that received a placebo alongside the same chemotherapy. The trial was measuring how long participants went without their disease getting worse (called progression-free survival), how long participants lived overall (overall survival), and what proportion of participants saw their tumours shrink or disappear (overall response rate). The reported data shows that, for the main outcome — time without disease progression — the bemarituzumab group had a median of 9.5 months, compared with 7.4 months in the placebo group. (Median means half the participants in each group reached that point before the other half.) For overall survival at the time of the initial analysis, a median figure was not yet calculable for the bemarituzumab group, while the placebo group had a median of 12.9 months. In a later, updated analysis of overall survival, the reported medians were 19.2 months for the bemarituzumab group and 13.5 months for the placebo group. The reported data also shows that 46.8% of participants in the bemarituzumab group had their tumours shrink or disappear, compared with 33.3% in the placebo group. Regarding side effects (called treatment-emergent adverse events), the reported data shows that 76 out of 76 participants in the bemarituzumab group and 76 out of 77 in the placebo group experienced at least one adverse event of any kind during the study period. Serious adverse events were reported in 57 participants in the bemarituzumab group and 48 in the placebo 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 ↗

  • NCT03662659 · results posted 9 May 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03662659) enrolled 274 people in total — 138 in the BMS-986213 plus chemotherapy group and 136 in the nivolumab plus chemotherapy group. The trial was comparing these two treatment combinations in people whose tumours tested positive for a protein called LAG-3 (found in at least 1% of tumour cells). The main thing researchers were measuring was the proportion of participants whose tumours shrank or disappeared — known as the "objective response rate" or ORR. The reported data shows that, among participants with LAG-3 positive tumours, 48.5% of those in the BMS-986213 plus chemotherapy group and 61.2% in the nivolumab plus chemotherapy group had their tumours shrink or disappear (the primary outcome). For secondary outcomes, the reported data shows that the median time participants kept that response (duration of response) ranged from around 7.7 months (BMS-986213 group) to 10.8 months (nivolumab group) in one analysis. The median time before the disease worsened or death occurred (progression-free survival) was reported as approximately 7.3 months versus 10.8 months, and median overall survival — the time from joining the trial until death from any cause — was reported as approximately 14.2 months versus 15.0 months, across the two groups respectively. Regarding adverse events (unexpected or unwanted medical occurrences during the trial), the reported data shows that all 135 treated participants in each group experienced at least one adverse event; serious adverse events were reported in 99 people in the BMS-986213 group and 87 in the nivolumab group; and adverse events leading to stopping treatment were reported in 76 and 56 participants respectively. 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 ↗

  • NCT00210184 · results posted 16 September 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people, all of whom received a combination of three chemotherapy medicines: irinotecan, fluorouracil, and leucovorin. Forty of the 42 participants completed the study, with two not completing it. The trial was set up to look at how many participants showed a measurable reduction in their tumour(s) after two months of treatment, as well as how long participants lived overall and how long they went without their cancer getting worse. The reported data shows that 25% of participants — that is, roughly one in four — had their tumours shrink by a meaningful amount (either completely disappearing or reducing in size by at least 30%) within the first two months. For the longer-term measurements, the reported data shows that the middle point for how long participants lived overall (called "overall survival," meaning the time from joining the trial until death from any cause) was 10 months. The middle point for how long participants went without their cancer growing or spreading (called "progression-free survival") was 7 months. These middle-point figures mean that half of participants reached that time and half did not — they are not averages. 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 ↗

  • NCT03196791 · results posted 12 July 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 196 people who were having a type of keyhole (laparoscopic) stomach surgery that included removal of nearby lymph nodes (small glands that are part of the immune system). Participants were split into two groups of 98: one group received a "deep" level of muscle-relaxing medication during surgery, and the other received a "moderate" level. The trial was measuring whether the depth of muscle relaxation made a difference to how many lymph nodes were removed, how smoothly the surgery went, and how much bleeding occurred. The reported data shows that the average number of lymph nodes removed per person was around 44.6 to 49.2 in the deep relaxation group, compared to around 39.2 to 41.5 in the moderate relaxation group, depending on the measurement point recorded. For surgical conditions, surgeons rated the operating environment on a scale of 1 (extremely poor) to 5 (optimal) at four different areas inside the body — the reported scores across those areas ranged from 4.1 to 4.4 in the deep group and 4.0 to 4.3 in the moderate group. The reported data also shows that 19 participants in the deep relaxation group experienced at least one interruption during surgery (such as movement, coughing, or muscle spasm), compared with 34 participants in the moderate relaxation group. Average intraoperative blood loss (bleeding during the operation) was reported as approximately 77.5 mL in the deep group and 74.2 mL in the moderate 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 ↗

  • NCT02178956 · results posted 10 May 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 357 people in each group — one group received a drug called napabucasin combined with paclitaxel (a chemotherapy medicine), and the other group received a placebo (an inactive dummy pill) combined with paclitaxel. The trial was looking at whether adding napabucasin to paclitaxel made a difference for people with advanced stomach or gastro-oesophageal junction cancer who had already tried one earlier treatment. The main thing being measured was how long people lived overall, with several secondary measures also tracked, including how long before the cancer got worse, how many people's cancer shrank or stopped growing, and how many people experienced side effects. The reported data shows that the median overall survival — that is, the point in time by which half the participants in each group had passed away — was 6.93 months in the napabucasin plus paclitaxel group and 7.36 months in the placebo plus paclitaxel group. For progression-free survival (the time until the cancer was recorded as getting worse or a person died), the reported figures were 3.55 months in the napabucasin group and 3.68 months in the placebo group. The reported data shows that 16 participants in the napabucasin group and 18 in the placebo group had their cancer shrink or show a complete response. When stable disease was also included, 55 participants in the napabucasin group and 58 in the placebo group had their disease recorded as controlled. Regarding adverse events (unwanted or unexpected health issues during the trial), 352 out of 357 participants in the napabucasin group and 338 out of 357 in the placebo group 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT02020252 · results posted 10 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people who were patients at an oncology (cancer) clinic. All 120 completed the study — none dropped out. The trial was looking at whether an interactive touchscreen tool, used by patients in the waiting room just before their appointment, was linked to how they felt and what they knew about cancer clinical trials (research studies that test new treatments). Participants answered questions measuring five things: how open they were to the idea of joining a trial (receptivity), how willing they were to join, how much they knew about clinical trials, how positively they viewed them, and how confident they felt about being involved. The reported data shows the following average scores out of the possible range for each area. Receptivity scored 4.6 out of 5, willingness scored 3.9 out of 5, knowledge scored 4.9 out of 6, positive attitudes scored 3.7 out of 5, and confidence (self-efficacy) scored 4.3 out of 5 — where a higher score was considered a more favourable result on each scale. For the secondary outcomes, the reported data shows that 102 out of 120 participants found the touchscreen tool easy to use, and various other interview questions about acceptability were answered positively by between 61 and 100 participants, depending on the specific question. On the question of real-world clinical trial activity, the reported data shows that 63% of participants discussed clinical trials with their doctor, 48% were offered a place in a clinical trial, and 38% went on to enrol in one. 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 ↗

  • NCT02454075 · results posted 29 January 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, all of whom completed the study. The trial was looking at whether a treatment called netazepide could cause a reduction in the size and number of certain stomach growths called type II gastric carcinoids, as well as changes in specialised stomach cells (called ECL cells) in people with a rare condition involving overproduction of stomach acid. Researchers measured the size of the growths using a camera procedure (endoscopy), took blood samples, and in some participants collected stomach fluid through a tube to measure acid levels. The reported data shows that for the primary goal of shrinking the stomach growths, the three participants had a mean percentage decrease in carcinoid size of 23.7%, 8.6%, and 10.8% respectively — none of which reached the 25% reduction threshold the trial had set as its target. For the second primary measure — a 25% reduction in ECL cell density — no numerical results were reported in the data submitted to ClinicalTrials.gov. For one secondary measure, levels of a blood marker called chromogranin A (a protein that can be elevated with certain stomach conditions) were recorded at multiple time points for two of the three participants; the reported figures ranged from 2,600 to 24,100 ng/mL for one participant and 2,700 to 11,950 ng/mL for another, while results for the third participant were listed as not available. Stomach fluid volume measurements were also reported across the three participants at different time points, with values ranging from 4 mL to 40 mL. Results for the remaining secondary measures — including changes in tissue grade and specialised cell markers — 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT03220217 · results posted 14 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03220217) enrolled 29 people in total across three groups (8, 10, and 11 participants respectively), with 27 completing the study. The trial was testing a PET/CT scanning agent called 68Ga-satoreotide trizoxetan in people with a type of tumour known as a gastroenteropancreatic neuroendocrine tumour (GEP-NET). Each participant received two scans using different combinations of the amount of the scanning agent (the peptide mass, measured in micrograms) and the level of radioactivity used (measured in MBq). The trial was measuring how well the scans could detect tumours compared to a standard CT scan, and what dose combinations produced the clearest images. The reported data shows that the primary outcome — how many tumour spots the PET scan picked up compared to the standard CT — was measured as a ratio (a number showing how the PET scan count compared to the CT count). Across the different dose combinations, the reported ratios for all organs ranged from about 2.1 to 3.8 for one set of measurements and around 0.5 to 1.0 for another set, depending on which dose group and which reading method was used. When results were grouped by peptide amount or radioactivity level alone, the reported ratios for all-organ readings ranged from approximately 2.6 to 3.1. For the primary tumour site specifically, reported ratios of around 1.0 were recorded across most groupings. For the secondary outcomes, the reported tumour-to-background ratios (a measure of how clearly a tumour stood out from surrounding tissue in the image) ranged widely — from about 2.2 to 26.4 depending on the dose combination and organ examined. A separate image quality scoring system, where two independent reviewers rated scan quality on a scale of 0 to 16, returned scores between 7 and 15 across the different radioactivity dose ranges. 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 ↗

  • NCT03708211 · results posted 29 December 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03708211) enrolled 20 participants in total — 12 in one group and 8 in another. It was a crossover study, meaning participants in each group took both forms of the drug TAK-931 (an 80 mg tablet and an 80 mg powder-in-capsule, or "PIC") but in different orders. The trial was measuring how the drug was absorbed into the bloodstream from each form, to see whether the two forms behaved similarly in the body. Notably, the reported data shows that zero participants were recorded as having "completed" the study under the structured milestones, and all 20 were listed as "not completed," though the reason for this is not explained in the submitted data. The reported data shows the following numbers for the main measurements: The peak level of TAK-931 detected in the blood (the highest concentration reached) was 251.45 ng/mL for the powder-in-capsule form and 270.09 ng/mL for the tablet form. The total amount of drug exposure over time — measured in two slightly different ways — was reported as approximately 1,869 and 1,901 (h·ng/mL) for the powder-in-capsule, and approximately 1,899 and 1,926 (h·ng/mL) for the tablet. These figures represent how much of the drug was present in the bloodstream across the full measurement period. The reported data shows that for the secondary measurements: the time it took to reach peak blood levels was about 1.68 hours for the powder-in-capsule and 1.98 hours for the tablet. The rate at which the body cleared the drug was approximately 42.1 litres per hour for the powder-in-capsule and 41.5 litres per hour for the tablet. The time for the drug level in the blood to reduce by half was around 7.3 hours for both forms. 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 ↗

  • NCT02082210 · results posted 19 December 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02082210) tested a drug called emibetuzumab, given together with another drug called ramucirumab, in people with certain types of advanced cancer. The trial had two parts: Part A looked at two different dose levels of emibetuzumab (750 mg and 2000 mg, with 3 people in each dose group) to check for serious side effects early on. Part B then enrolled larger groups across four cancer types — gastric (stomach) cancer (16 people), liver cancer known as HCC (45 people), kidney cancer known as RCC (15 people), and a type of lung cancer known as NSCLC (15 people). In total, 97 people started the trial and received at least one dose of the study drug. The reported data shows that in Part A, no participants in either dose group experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect serious enough during the first treatment cycle to count as a predefined limit. For Part B, the trial measured how many participants' tumours shrank significantly (called the overall response rate). The reported figures were: 6.3% of gastric cancer participants, 6.7% of liver cancer participants, 0% of kidney cancer participants, and 6.7% of lung cancer participants showed a meaningful tumour shrinkage. The reported data also shows how long participants went, on average, before their disease progressed or they passed away (called progression-free survival): roughly 1.6 months for gastric cancer, 5.4 months for liver cancer, 2.9 months for kidney cancer, and 6.6 months for lung cancer. The proportion of participants whose disease did not worsen — either shrinking or staying stable — ranged from about 47% in the kidney cancer group up to about 87% in the lung cancer group. On the drug's behaviour in the body, the reported data shows that the peak level of emibetuzumab measured in the blood was 210 micrograms per millilitre at the lower dose and 575 micrograms per millilitre at the higher dose, with the overall drug exposure also roughly proportionally higher at the larger dose. These figures reflect how the drug was absorbed and circulated, not a measure of how well it worked. 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 ↗

  • NCT03515941 · results posted 12 October 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03515941) enrolled a total of six people — four in a group receiving adjuvant chemotherapy (additional chemotherapy given after initial treatment) and two in a group receiving adjuvant chemoradiation (a combination of chemotherapy and radiation given after initial treatment). The trial was measuring whether participants could complete their recommended course of treatment, and also tracking how long it took before any signs of the disease came back. It is important to note that the trial closed early on 18 June 2020 due to difficulty recruiting enough participants. The reported data shows that, of the four people in the chemotherapy group, three completed their recommended treatment, while one did not. In the chemoradiation group, both participants completed their recommended treatment. These are the only completion numbers reported. Regarding the second measure — the median time until the disease showed signs of returning — the data was not reported for either group, most likely because the trial closed before enough information could be gathered to calculate this figure. Because this trial ended much earlier than planned and involved only six people in total, the numbers reported are very limited. 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 ↗

  • NCT03279237 · results posted 7 May 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03279237) enrolled 25 people with a form of pancreatic cancer. All participants received a combination of chemotherapy (called FOLFIRINOX) followed by chemotherapy given alongside radiation therapy before surgery. The trial's main goal was to measure how many participants were able to complete this combined treatment plan. Secondary goals included tracking side effects, measuring how tumours responded on scans, looking at whether any tumours had completely disappeared when examined under a microscope after surgery, and monitoring how long participants lived without their disease getting worse and overall survival. The reported data shows that 23 out of 25 participants completed the chemotherapy combined with the radiation phase, which was the primary thing being measured. For the secondary measures, the reported data shows that all 25 participants experienced at least one side effect that was considered related to the treatment, as recorded using a standard side-effect tracking tool. Twenty out of 25 participants showed a measurable response in their tumour on scans — meaning their tumours either disappeared entirely on imaging or shrank by at least 30%. Of the 20 participants who went on to have surgery, 7 had no detectable living tumour cells remaining in the tissue removed during their operation. The reported data for progression-free survival (how long before the disease worsened) and five-year overall survival were 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02545504 · results posted 28 April 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02545504) enrolled 432 people with gastric (stomach) cancer — 218 received a combination of an experimental drug called andecaliximab plus a standard chemotherapy regimen known as mFOLFOX6, while 214 received a placebo (an inactive substance) plus the same chemotherapy. The trial was primarily measuring how long participants lived overall, and secondarily looking at how long their disease took to worsen, how many showed tumour shrinkage, and what unwanted medical events occurred during the study. The reported data shows that, for overall survival (how long participants lived from the start of the trial), the andecaliximab group had a reported median of 12.52 months compared with 11.76 months in the placebo group. (A "median" means half the participants lived longer than this figure and half did not reach it.) For progression-free survival (the time before the disease got worse or a participant died), the reported median was 7.46 months in the andecaliximab group and 7.06 months in the placebo group. For the objective response rate — meaning the percentage of participants whose tumours shrank by a meaningful amount or disappeared entirely — the reported figure was 50.5% in the andecaliximab group and 41.1% in the placebo group. Regarding unwanted medical events that occurred during the trial, the reported data shows that 99.1% of participants in the andecaliximab group and 99.5% in the placebo group experienced at least one treatment-emergent adverse event (an unexpected medical occurrence during the study period). Abnormal laboratory test results were also recorded for a large proportion of participants in both groups, with the exact percentages varying depending on which type of abnormality was being measured. These figures describe what was recorded during the trial and do not on their own indicate whether any specific event was caused by 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 ↗

  • NCT02494583 · results posted 13 March 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02494583) enrolled 763 people across three groups: 256 received pembrolizumab on its own, 257 received pembrolizumab combined with standard chemotherapy, and 250 received a placebo combined with standard chemotherapy. The trial was measuring how long participants lived without their cancer growing (called progression-free survival), how long they lived overall (overall survival), and what proportion of participants saw their tumours shrink or disappear (called objective response rate). Results were looked at separately for participants whose tumours showed different levels of a protein marker called PD-L1 — specifically those with a score of 1 or above, and those with a score of 10 or above. The reported data shows the following median time figures — meaning the point at which half of participants in that group had reached the measured event. For how long participants lived without cancer growth, the pembrolizumab-plus-chemotherapy group had a median of 6.9 months compared with 6.4 months in the placebo-plus-chemotherapy group (among those with a PD-L1 score of 1 or above). For overall survival among participants with a PD-L1 score of 1 or above, the pembrolizumab-plus-chemotherapy group had a median of 12.5 months versus 11.1 months for the placebo-plus-chemotherapy group; and for those with a PD-L1 score of 10 or above, 12.3 months versus 10.8 months. When pembrolizumab alone was compared to placebo-plus-chemotherapy, the reported median overall survival among those with a PD-L1 score of 1 or above was 10.6 months versus 11.1 months, and among those with a PD-L1 score of 10 or above, 17.4 months versus 10.8 months. For tumour shrinkage or disappearance, 48.6% of participants in the pembrolizumab-plus-chemotherapy group and 37.2% in the placebo-plus-chemotherapy group (PD-L1 score of 1 or above) were reported to have met that measure. Results for several other comparisons were not 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01362127 · results posted 26 February 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01362127) involved 181 people with a type of cancer affecting the oesophagus (food pipe) or the junction where it meets the stomach. Participants were split into two groups: 90 received a combination of radiation and chemotherapy before surgery (radiochemotherapy), and 91 received chemotherapy alone before surgery. The trial was looking at whether one approach led to more cases of no detectable cancer remaining in the removed tissue after surgery — a result doctors call a "pathological complete response" — and also gathered information on quality of life and swallowing ability. The reported data shows that, when examining the tissue removed during surgery, 22 out of 90 participants in the radiochemotherapy group had no detectable cancer remaining in their tissue sample, compared with 7 out of 91 participants in the chemotherapy-only group. For the secondary outcome looking at safety — specifically, how many participants went on to have major surgery after their pre-surgery treatment — the reported data shows 79 out of 90 in the radiochemotherapy group and 81 out of 91 in the chemotherapy group proceeded to surgery. Regarding quality of life and swallowing, participants completed questionnaires scored on a scale of 0 to 100. The reported data shows average scores of 67 (radiochemotherapy) and 69 (chemotherapy only) on one measure, and 27 (radiochemotherapy) and 31 (chemotherapy only) on another measure, though the trial record does not specify which particular aspects of quality of life these individual figures correspond 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01939275 · results posted 8 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01939275) enrolled 8 participants, and all 8 completed the study with none dropping out. The trial was looking at a type of medical imaging scan using a radioactive substance called Copper Cu 64-DOTA-trastuzumab, combined with a PET scan (a type of body-scanning technology that detects radioactive signals). The aim was to see how tumours appeared on these scans in people whose cancer had already been tested for something called HER2 status — a biological marker that can vary between cancers. The reported data shows that two radiologists (specialist doctors who read medical scans) reviewed the images. To reduce the chance of bias, one of the radiologists was not told where the tumour was or what the patient's HER2 result was before reviewing the scan. Each tumour was described based on whether it appeared "hot" (meaning it showed up brightly) compared to the surrounding tissue, and was then recorded as negative, positive, equivocal (meaning uncertain), or unknown. According to the results reported on ClinicalTrials.gov, out of the 8 participants: 5 were recorded as HER2 negative with a negative tumour reading, 1 was recorded as HER2 negative with a positive tumour reading, and 2 were recorded as HER2 negative with an equivocal (uncertain) tumour reading. No participants were recorded in the remaining categories. Results for HER2 positive or equivocal participants were not reported in the submitted data. It is worth noting that this was a very small study with only 8 participants, and the reported data does not include results for all possible participant 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 ↗

  • NCT02374255 · results posted 1 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02374255) looked at a "Goals of Care" (GoC) intervention — a structured approach to helping cancer patients and their oncologists have conversations about the patient's goals and wishes for their care. A total of 265 people took part across four groups: 155 patients who received the GoC intervention, 110 patients who received usual care, and 11 oncologists in each of the two groups (intervention and usual care). The reported data shows two primary things that were measured — both based on patient surveys. First, when asked whether goals of care discussions had increased, 43 out of the patients in the GoC intervention group said yes, compared with 34 out of the usual care group. Second, when asked whether they were satisfied that their goals of care discussions had improved, 70 patients in the GoC intervention group reported this, compared with 65 in the usual care group. No figures were reported for the oncologist groups on these two measures. For the secondary measure, oncologists were rated on their communication skills on a scale of 1 to 7 (where a higher number means they felt more comfortable having goals of care conversations). The reported data shows oncologists in the GoC intervention group scored an average of 3.7, compared with 2.2 for oncologists in the usual care group. No data for patients was reported on 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT00780494 · results posted 18 September 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom completed the study. Every participant received the same combination of three medicines: bevacizumab, carboplatin, and capecitabine. The trial was measuring how long participants lived without their cancer growing (called progression-free survival), how long participants lived overall, how their tumours responded to treatment, and what serious side effects occurred. Blood marker tests (CEA, CA 19.9, and VEGF) were also planned to be measured, but no data for those was reported. The reported data shows that, of the participants who could be assessed at the one-year mark, 9 were alive without their cancer having grown at that point. For overall survival, the reported median (the middle value when all survival times are lined up) was 458 days. Regarding how tumours responded, the reported data shows that 18 out of 35 participants had either a complete response (all detectable tumour lesions disappeared) or a partial response (tumour lesions shrank by 30% or more); none of the 18 were recorded as a complete response, meaning all 18 were partial responses. A further 6 participants had stable disease (small changes that did not meet the criteria for shrinkage or growth), and 5 participants had progressive disease (cancer that grew or spread). The reported data also shows that there were 18 recorded serious side effects (grade 3 or above, meaning significant or severe) considered possibly or definitely linked to bevacizumab — 3 of these involved the blood system and 15 did not. 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 ↗

  • NCT01236352 · results posted 21 May 2019

    According to the results reported on ClinicalTrials.gov, this trial investigated a drug called BMS-911543 in people with a bone marrow condition called myelofibrosis. A total of 84 participants took part across 11 groups, with each group receiving a different dose of the drug — ranging from 5 mg up to 240 mg. The trial had two phases: a Phase I portion testing nine different doses (with 4–8 people per group) and a Phase II portion testing two doses (120 mg and 200 mg, with 22 and 20 people respectively). The trial was measuring two main things: how many participants experienced adverse events (unwanted medical events during the study), and how many participants showed a measurable response to treatment based on standard criteria used in myelofibrosis research. The reported data shows that the number of participants recorded as having adverse events was small across most dose groups — one participant each in the 5 mg, 80 mg, 120 mg, and 160 mg Phase I groups; two participants in the 200 mg Phase I group; and one participant in the 120 mg Phase II group. No adverse events were reported in the remaining groups. For the "best overall response" outcome, the reported numbers show zero participants in every group achieved a recorded response under the criteria used. Almost all participants across all groups did not complete the study — only one participant (in the 40 mg Phase I group) was recorded as having completed it. The reported data shows that several secondary outcomes — including blood and plasma measurements and drug concentration levels — were not completed and no numbers were reported for these, as the sponsor ended the trial early due to business decisions unrelated to any safety concerns. 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 ↗

  • NCT02625623 · results posted 15 October 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02625623) enrolled 371 people in total — 186 were assigned to receive a chemotherapy chosen by their doctor plus best supportive care, and 185 were assigned to receive a drug called avelumab plus best supportive care. The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked a number of secondary measures including how long it took for the disease to progress, how tumours responded to treatment, and how participants rated their own health and quality of life. The reported data shows that the median overall survival — that is, the point at which half the participants in each group had died and half were still alive — was 5.0 months in the chemotherapy group and 4.6 months in the avelumab group. For progression-free survival (the time before the disease worsened or a participant died), the reported median was 2.7 months in the chemotherapy group and 1.4 months in the avelumab group. The objective response rate — the proportion of participants whose tumour shrank to a defined degree — was reported as 4.3% in the chemotherapy group and 2.2% in the avelumab group. For quality-of-life scores measured at the end of treatment, both groups showed a decline from their starting scores, with the chemotherapy group declining by 0.103 points and the avelumab group by 0.144 points on one scale, and by 12.3 mm and 13.6 mm respectively on a separate 0–100 self-rated health scale (where higher scores mean better health). 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 ↗

  • NCT00354224 · results posted 16 July 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom received a combination of two chemotherapy drugs — oxaliplatin and capecitabine. All 10 participants completed the study. The trial was designed to measure how well the tumours responded to treatment (by looking at whether they shrank or disappeared on scans), how long participants lived without their cancer getting worse, and how many serious unwanted health events occurred. The reported data shows that no numbers were provided for the main (primary) outcome — tumour response rate — meaning those results were not reported in the data submitted to ClinicalTrials.gov. Similarly, no figures were reported for progression-free survival (the length of time participants went without their cancer worsening). For the secondary outcome measuring serious adverse events (unexpected or harmful health occurrences considered serious in nature), the reported data shows that 4 serious adverse events were recorded across the 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 ↗

  • NCT02443883 · results posted 13 March 2018

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called ramucirumab, tested across four different dosing regimens. A total of 164 people started the study (40, 42, 41, and 41 across the four groups), and 161 of them received at least one dose of the study medicine. The trial's main focus was on how the drug moved through the body — specifically, measuring the lowest level of ramucirumab remaining in the blood between doses (called the "minimum concentration"). It also looked at whether participants developed antibodies against the drug, and how many participants showed no sign of their disease getting worse at their first check-up at six weeks. The reported data shows that the lowest blood levels of ramucirumab varied across the four dosing groups and were measured at several points during the study. Across the time points reported, the figures ranged from 32.9 to 122 micrograms per millilitre depending on the group and when the measurement was taken, with Regimens 3 and 4 generally showing higher readings at later time points. For the antibody measure, the reported data shows that zero participants in any of the four groups developed antibodies against the drug during the study. Regarding the six-week check on disease progression, the reported data shows that the percentage of participants whose disease had not progressed at that point was 43.9% in Regimen 1, 61.9% in Regimen 2, 53.0% in Regimen 3, and 51.2% in Regimen 4. It is important to note that these figures simply describe what was measured and recorded — they do not on their own tell us whether one regimen is better than another, and no conclusions about the medicine's overall effectiveness or safety should be drawn from this summary alone. 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 ↗

  • NCT01774786 · results posted 14 February 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01774786) enrolled 780 people in total — 388 in the group receiving pertuzumab, trastuzumab, and chemotherapy, and 392 in the group receiving a placebo (inactive substitute) alongside trastuzumab and chemotherapy. The trial's main goal was to measure overall survival — that is, how long participants lived from the time they joined the study. It also tracked a number of secondary measures, including how long it was before the cancer got worse (called progression-free survival), how many participants' tumours shrank or disappeared (the objective response rate), how long those responses lasted, and how many participants experienced any clinical benefit from treatment. The reported data shows that, for the primary measure of overall survival, the median time — meaning the point at which half the participants in each group had died — was reported as 17.5 months in the pertuzumab group compared with 14.2 months in the placebo group. For progression-free survival (time before the cancer worsened or death occurred), the reported median was 8.5 months in the pertuzumab group and around 7.0–7.2 months in the placebo group. The reported data shows that approximately 57% of participants in the pertuzumab group had their tumour shrink or disappear, compared with around 49% in the placebo group. The duration of that response was reported as a median of 10.2 months in the pertuzumab group and 8.4 months in the placebo group. For clinical benefit (which included stable disease lasting at least six weeks, as well as tumour shrinkage), the reported figures were approximately 85% in the pertuzumab group and 81% in the placebo 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 ↗

  • NCT01683864 · results posted 30 January 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01683864) was designed to look at three groups of people with stomach cancer who either had or did not have cancer cells detected in fluid around their abdominal organs. The three groups were: people with cancer cells detected who received a specialised heated chemotherapy wash to the abdomen (known as HIPEC), people with cancer cells detected who did not receive that treatment, and people without cancer cells detected who did not receive it. The trial planned to measure how long participants remained free of cancer spreading to the lining of the abdomen, how long they remained free of disease overall, any complications related to the procedure, and how the chemotherapy drugs moved through the body. The reported data shows that, although three patients were enrolled in the trial, zero participants are recorded as having started, completed, or left the study across all three groups. According to the results reported on ClinicalTrials.gov, no patient received the study treatment, and as a result, no numerical outcome data was collected or reported for any of the planned measures — including cancer-free survival, disease-free survival, complications, or drug behaviour in the body. Because no one received the study treatment, the trial did not produce any findings about the outcomes it set out to measure. The data was not reported for any of the outcome measures due to the study not proceeding as planned. 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 ↗

  • NCT00911820 · results posted 9 November 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT00911820) enrolled 88 people in total — 45 in one group receiving a treatment combination called PCA (Arm A) and 43 in a group receiving a slightly different combination called TPCA (Arm B). The trial was comparing these two chemotherapy combinations in people with cancer, looking mainly at how many participants were still alive and had not seen their cancer grow or spread after seven months. It also tracked how long people lived overall, whether tumours shrank, and how long it took before the cancer progressed. The reported data shows that for the main measure — the estimated probability of being alive and progression-free at seven months — both groups returned very similar figures: approximately 0.581 (or about 58 in every 100 people) in the PCA group and 0.582 (also about 58 in every 100 people) in the TPCA group. For overall survival (time from joining the trial until death or last known to be alive), the reported median was 11.7 months in the PCA group and 13.4 months in the TPCA group. The reported data also shows that in the PCA group, 3 participants had a complete response (tumour fully disappeared on scans), 22 had a partial response (tumour shrank by at least 30%), 15 had stable disease (no significant change), 1 was not assessed, and 3 had disease progression. In the TPCA group, the corresponding numbers were 0, 21, 14, 0, and 6 respectively. The overall response rate (the proportion whose tumours shrank meaningfully or disappeared) was reported as approximately 57% for PCA and 51% for TPCA. The median progression-free survival (time until the cancer grew or the person died) was reported as 7.9 months for PCA and 8.4 months for TPCA. 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 ↗

  • NCT01649271 · results posted 6 November 2017

    According to the results reported on ClinicalTrials.gov, this was a small early-phase trial (called Phase Ia) that enrolled 13 people in total — 6 in a group receiving a lower dose of afatinib (20 mg) combined with trastuzumab, and 7 in a group receiving a higher dose of afatinib (30 mg) combined with trastuzumab. The main thing the trial was measuring was the highest dose of afatinib that could be given alongside trastuzumab before too many participants experienced serious side effects in the first treatment cycle — this is known as the Maximum Tolerated Dose (MTD). No participants were recorded as having completed the study in the formal sense, as this type of early trial tracks participants differently from standard completion. None of the 13 participants finished under the "completed" category. The reported data shows that the MTD of afatinib in combination with trastuzumab was identified as 20 mg. In terms of serious side effects during the first cycle (called dose-limiting toxicities, or DLTs — meaning side effects severe enough to limit how much of the drug can be given), 1 out of 6 participants in the lower-dose group and 2 out of 6 evaluable participants in the higher-dose group experienced these. One person in the higher-dose group developed a condition called tumour lysis syndrome early in treatment and was not included in the DLT count. The trial also looked at how tumours responded to treatment using standard measurement criteria. The reported data shows that in the lower-dose group, 16.7% of participants had a partial response (meaning their tumours shrank by at least 30%), while 0% in the higher-dose group did. Stable disease (tumours neither growing nor shrinking enough to qualify as a response) was reported in 16.7% of the lower-dose group and 0% of the higher-dose group. When combining any sign of benefit — partial response or stable disease — the reported figures were 33.3% in the lower-dose group and 100% in the higher-dose group, though the very small numbers mean these percentages should be read with caution. 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 ↗

  • NCT00725712 · results posted 24 August 2017

    According to the results reported on ClinicalTrials.gov, this trial studied a drug called GSK1363089 in 74 people in total. Participants were split into two groups based on how they took the drug: 48 people followed an "intermittent" schedule (taking the drug on certain days of a cycle), and 26 people followed a daily dosing schedule. The trial was measuring whether tumours shrank in response to the drug (called the objective response rate), as well as tracking participants' physical signs such as blood pressure, heart rate, breathing rate, and temperature. It also recorded any unwanted medical events (called adverse events) and any serious adverse events that occurred during the study. The reported data shows that no participants in either group completed the study, though the data does not explain the reasons for this in detail. The reported data shows that when it came to tumour response, zero participants in either the intermittent dosing group or the daily dosing group had their tumours shrink to the level required to count as a response (either a complete disappearance or a significant partial shrinkage). Regarding unwanted medical events, all 48 participants in the intermittent group and all 26 in the daily group experienced at least one adverse event. Serious adverse events were reported in 22 out of 48 people in the intermittent group and 16 out of 26 in the daily group. For the physical measurements, the reported data shows small fluctuations up and down from starting levels in blood pressure, heart rate, breathing rate, and temperature across both groups, though the trial report does not indicate whether these changes were considered meaningful. 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 ↗

  • NCT02202759 · results posted 15 May 2017

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called MLN0264 (given at a dose of 1.8 mg/kg) in 38 people with cancer. Participants were divided into three groups based on how much of a particular protein — called GCC — was present in their tumour tissue: low (9 people), intermediate (15 people), and high (14 people). The trial was primarily measuring how many participants' tumours shrank or disappeared in response to the drug, and it also tracked a range of other things including how long it took for the disease to get worse, and what unwanted medical events occurred. No participant was recorded as having completed the study in the conventional sense — all 38 were listed under "not completed." The reported data shows that, for the main outcome (the proportion of participants whose tumours shrank significantly or disappeared completely), the result was 0% in the low-GCC group, 14% in the intermediate-GCC group, and 0% in the high-GCC group. For the secondary outcome measuring how long it took before the disease progressed or a participant died, the reported median figures were 40 days for the low-GCC group, 49 days for the intermediate-GCC group, and 87 days for the high-GCC group. Among those who did show a response, the reported duration of that response was 45.5 days on average across all groups combined. The reported data also shows that unwanted medical events (called adverse events) were recorded in 8 out of 9 people in the low-GCC group, all 15 people in the intermediate-GCC group, and all 14 people in the high-GCC group. Serious adverse events — meaning events that were life-threatening, required hospitalisation, or caused significant disability — were recorded in 2 people in the low-GCC group, 5 people in the intermediate-GCC group, and 0 people in the high-GCC group. Significant abnormal laboratory test results (graded as severe or worse) were reported across the combined participant group, though the full breakdown by subgroup was not reported separately for all laboratory 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT00938470 · results posted 10 April 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT00938470) enrolled 62 people in total — 34 in one group who received a combination of docetaxel (a chemotherapy medicine), 5-fluorouracil, oxaliplatin, and radiation therapy before surgery (Arm I), and 28 in a second group who received 5-fluorouracil, oxaliplatin, and radiation therapy before surgery without the docetaxel (Arm II). The trial was mainly measuring how often tumours completely disappeared from surgical tissue samples — known as a "pathologic complete response" — after treatment before surgery. It also tracked how long participants lived overall, how long they lived without their disease returning, how their tumours responded during treatment, and how many experienced serious side effects. The reported data shows that, for the primary measure, 28.6% of participants in Arm I and 40.7% in Arm II had no detectable tumour remaining in their surgical specimen. For overall survival — the length of time from entering the trial until death from any cause — the figure for Arm I was not reported in the submitted data, while Arm II recorded a median of 18.8 months. For disease-free survival — time from entering the trial until the disease came back or death, whichever happened first — Arm I recorded a median of 31.2 months and Arm II recorded 17.0 months. The reported data also shows that, for overall clinical tumour response (tumours that shrank significantly or disappeared during treatment), 32.1% of Arm I participants and 33.3% of Arm II participants met that measure. Regarding serious side effects (graded as severe or above on a standard medical scale), the data as submitted contained multiple sets of figures across different categories, but the individual breakdowns for each category were not clearly labelled in the submitted results, so a complete description cannot be provided here without risking inaccuracy. 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 ↗

  • NCT01355302 · results posted 13 March 2017

    According to the results reported on ClinicalTrials.gov, this trial was designed to run in two stages. The first stage (Phase 1b) enrolled 7 participants who received a combination of three drugs: golvatinib, capecitabine, and cisplatin. This early phase was primarily focused on measuring how the drug golvatinib moved through the body — specifically how much of it entered the bloodstream and how quickly. The trial was planned to then move into a larger second stage (Phase 2) comparing the three-drug combination against capecitabine and cisplatin alone, but the study was terminated before any participants were enrolled in that phase. The reported data shows the following numbers from the 7 Phase 1b participants. For golvatinib's total exposure in the blood over 24 hours (a measure called "area under the curve," which reflects how much drug the body was exposed to over time), two separate measurements were reported: 23,400 and 26,300 nanograms·hour per millilitre. The peak level of golvatinib measured in the blood was reported as 1,680 and 1,620 nanograms per millilitre across two measurement points. The time it took to reach that peak level was reported as 3.00 hours and 6.07 hours. All 7 participants who started the Phase 1b portion were recorded as having experienced at least one adverse event (an unwanted or unexpected health occurrence during the study period). Because the trial was stopped early, the secondary outcomes — including how many participants' tumours responded to treatment and how long it took for the disease to progress — were never measured, and no data for those outcomes 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 ↗

  • NCT01457846 · results posted 7 March 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01457846) enrolled 71 people in total — 41 assigned to receive a medicine called AZD4547 and 30 assigned to receive paclitaxel (a chemotherapy medicine). The trial was looking at patients with a particular type of stomach or oesophageal cancer and was comparing the two treatments across several measures, the main one being how long patients went without their cancer growing or spreading (called "progression-free survival"). The reported data shows that the median time without disease progression — meaning half of patients reached this point or sooner — was 1.8 months in the AZD4547 group and 3.5 months in the paclitaxel group. For the secondary measures: the proportion of patients whose tumours shrank by a meaningful amount (known as the "objective response rate") was reported as 2.6% in the AZD4547 group and 23.3% in the paclitaxel group. When looking at tumour size changes at eight weeks, the AZD4547 group showed an average increase in tumour size of 28.4%, while the paclitaxel group showed an average decrease of 1.1%. The percentage of patients who had not experienced disease progression at eight weeks was 24.4% in the AZD4547 group and 53.3% in the paclitaxel group. Regarding deaths recorded by the data cut-off point, 27 patients in the AZD4547 group and 18 in the paclitaxel group had died. It is worth noting that no participants were recorded as having formally "completed" the trial in the usual sense, and the data reflects the state of the study at a set cut-off date. 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 ↗

  • NCT01450696 · results posted 28 November 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 296 people in total — 148 in each of two groups. Both groups received the same chemotherapy combination (capecitabine and cisplatin) alongside Herceptin (also known as trastuzumab), but at different doses: one group received 6 mg/kg of Herceptin and the other received 10 mg/kg. The trial was primarily measuring how long participants lived overall, and what proportion had died by the time data collection was finalised on 13 February 2015. The reported data shows that, among all enrolled participants, 46.8% in the 6 mg/kg group and 54.0% in the 10 mg/kg group had died by the data cut-off date. The median overall survival — meaning the point in time by which half the participants in each group had died — was reported as approximately 12.5 months for the 6 mg/kg group and 10.6 months for the 10 mg/kg group. For a more strictly defined subset of participants (called the "Per Protocol Set"), the reported median overall survival figures were approximately 10.8 months and 9.4 months respectively. The reported data also shows that, within this same subset, the median time until disease worsened or death occurred (called progression-free survival) was approximately 5.4 months in the 6 mg/kg group and 4.4 months in the 10 mg/kg group. It is worth noting that the reported data shows zero participants were recorded as having formally "completed" the trial in either group, which the data does not explain further. No safety outcome numbers were included in the structured results submitted to ClinicalTrials.gov, so those figures are not available to report 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 ↗

  • NCT01611857 · results posted 23 November 2016

    According to the results reported on ClinicalTrials.gov, this trial involved 49 people in total — 15 in a dose-finding phase and 34 in a later expansion phase. The trial was testing a combination of two treatments: tivantinib (a tablet taken twice daily) and FOLFOX (a chemotherapy regimen given by drip). The first part of the trial aimed to find the highest dose of tivantinib that could be given alongside FOLFOX without causing serious side effects (called "dose-limiting toxicities"). The second part then looked at how long participants went without their disease getting worse, how long they survived overall, and how long it took for their disease to progress. The reported data shows that in the dose-finding phase, participants received tivantinib at three different dose levels — 120 mg, 240 mg, and 360 mg. No dose-limiting toxicities were recorded at the 120 mg or 240 mg levels, and one was recorded at the 360 mg level. Based on this, the 360 mg dose was carried forward into the expansion phase. For the 34 participants in the expansion phase, the reported data shows that the average time until the disease progressed or a participant died was 6.1 months (a measure called "progression-free survival"). The average time from the start of treatment until death from any cause (called "overall survival") was reported as 9.6 months. The average time specifically until the disease was seen to progress — not counting deaths — was reported as 7.0 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 ↗

  • NCT01664494 · results posted 2 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 563 participants, all of whom received capecitabine, a type of oral chemotherapy tablet. A total of 370 participants completed the study, while 193 did not complete it. The trial was an observational study — meaning researchers watched how the medicine was being used in everyday clinical practice rather than testing it against another treatment. It looked at things like which stage or "line" of treatment doctors were choosing capecitabine for, and what doses were being given, across several cancer types including colorectal, gastric (stomach), and breast cancers. The reported data shows that, when it came to how capecitabine was being used across different lines of treatment, 220 participants received it as one line of treatment, 176 as another, 89 as a further line, and 78 as an additional line. The trial data does not provide labels clearly identifying which specific line of treatment each of these numbers corresponds to, so a precise breakdown cannot be given here. For the secondary outcome — the typical (median) dose used — the reported data shows a median dose of 3,500 milligrams for one cancer type and 3,000 milligrams for another. The data does not specify which cancer type corresponds to which dose figure. 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 ↗

  • NCT00985192 · results posted 29 March 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people who had been previously treated for an advanced form of upper gastrointestinal cancer (a cancer of the stomach or nearby digestive tract area that could not be surgically removed or had spread to other parts of the body). All participants received a drug called everolimus. The trial was measuring whether the cancer stopped growing or shrank (called "disease control"), how long participants lived overall, and how long it was before the cancer started progressing again. Forty-five of the 49 participants completed the study, with four not completing it (no further detail on why was reported here). The reported data shows that 40% of participants had their disease considered "under control" — meaning their cancer either shrank, disappeared completely, or stayed stable rather than growing, based on standard imaging assessment criteria. For overall survival — meaning the time from starting treatment until death — the reported median figure (the midpoint value where half the group fell above and half below) was 3.4 months. For progression-free survival — the time until the cancer started growing again or until death — the reported median was 1.8 months. The trial also looked at certain biological markers in tumour tissue samples to explore whether they might relate to outcomes; the reported data shows varying numbers of tissue samples across different marker categories, and median progression-free survival figures for different marker subgroups ranged from 1.8 to 3.5 months, though the full context and labels for each subgroup 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 ↗

  • NCT01130337 · results posted 1 October 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people, all of whom received a combination of three medicines: capecitabine, oxaliplatin, and trastuzumab. The trial was measuring how participants with a particular type of cancer responded to this treatment combination, including whether their tumours shrank, whether surgery could fully remove the tumour, and whether participants remained free of disease progression 18 months after surgery. The reported data shows that 76.12% of participants were free from disease progression at the 18-month mark after surgery — this was the main thing the trial set out to measure. For the additional measures, the reported data shows that 38.89% of participants had their tumour shrink or disappear during treatment (what the researchers called an "objective response"). Around 90.32% of participants who went on to have surgery had their tumour completely removed with clear margins (meaning no cancer cells were detected at the edges of what was removed). A smaller proportion — 8.33% — showed no detectable invasive cancer cells remaining in the primary tumour at the time of surgery (called a "pathological complete response"). Of the 36 people who started the trial, 22 completed it and 14 did not, though the reasons for not completing were not detailed in the data provided here. It is worth noting that this was a single-group trial with no comparison group, and the numbers involved were relatively small (36 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 ↗

  • NCT00879333 · results posted 6 April 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00879333) enrolled 656 people with gastric (stomach) cancer — 439 received a daily 10 mg dose of everolimus (a tablet treatment) plus best supportive care, and 217 received a placebo (a dummy tablet) plus best supportive care. The trial's main goal was to compare how long people in each group lived overall, and it also tracked how long it took for the cancer to worsen, how patients felt in terms of daily functioning and quality of life, and how the drug was absorbed into the bloodstream. The reported data shows that for the primary measure — overall survival (how long people lived from the start of the trial) — the everolimus group had a median of 5.39 months, compared to 4.34 months in the placebo group. (Median means half the people in that group lived longer than this figure, and half lived less.) For the secondary measure of progression-free survival (time until the cancer was recorded as worsening or the person died), the reported median was 1.68 months for the everolimus group and 1.41 months for the placebo group. When looking at overall tumour response, out of 379 everolimus participants with measurable disease, 17 showed a response (1 complete, 16 partial), compared to 4 out of 191 in the placebo group. Measures of quality of life deterioration and physical functioning decline were broadly similar between the two groups, ranging from around 1.4 to 1.9 months across the different scales assessed. The reported data also shows blood concentration levels of everolimus measured at Week 5: among those on the full 10 mg daily dose, the pre-dose (trough) level was approximately 16.1 ng/mL and the peak level was approximately 72.8 ng/mL; for those on a reduced 5 mg daily dose, the figures were approximately 10.5 ng/mL and 37.3 ng/mL respectively. It is worth noting that the vast majority of participants in both groups did not complete the full study treatment — only 11 people in the everolimus group and none in the placebo group were recorded as completing treatment, which the data does not explain further. 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 ↗

  • NCT00454363 · results posted 1 April 2015

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called pazopanib in people with two types of neuroendocrine tumours — carcinoid tumours and pancreatic neuroendocrine tumours (pNET). A total of 51 people took part: 20 in the carcinoid group and 31 in the pNET group. The main thing the trial was measuring was how many participants' tumours shrank — either completely or by at least 30% — based on a standard set of measurement rules called RECIST. The reported data shows that in the carcinoid group, none of the 20 participants had their tumours shrink enough to meet those criteria, while 14 had stable disease (meaning tumours neither shrank enough to count as a response nor grew enough to count as progression), and 3 had their disease progress. In the pNET group, 6 out of 31 participants met the tumour shrinkage criteria, 21 had stable disease, 3 had progression, and 1 was recorded separately. For a secondary measure looking at changes in blood flow to tumours (assessed by a specialised CT scan), a figure of 139% change was reported for the pNET group only — the data for the carcinoid group was not reported. The reported data also shows that the time from the start of treatment until the disease progressed or death occurred (called progression-free survival) was 12 months on average for the carcinoid group and 14.2 months for the pNET group. Results for blood levels of the drug were listed as not available for 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 ↗

  • NCT00553696 · results posted 13 March 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00553696) enrolled 27 people in total across four treatment groups, all of whom received a combination of the drug sunitinib (at different doses and schedules) together with two chemotherapy medicines called S-1 and cisplatin. The trial was a dose-finding study — its main goal was to identify how many participants experienced serious unwanted side effects (called "dose-limiting toxicities," or DLTs) during the first four weeks of treatment, to help work out a safe starting dose for future research. Notably, none of the 27 participants completed the study as defined by the trial protocol. The reported data shows that, looking at the primary measure — serious side effects in the first treatment cycle — 2 out of 4 participants in the "Sunitinib 25 mg continuous daily" group experienced a DLT, 1 out of those in the "Sunitinib 25 mg (2 weeks on, 2 weeks off) dose escalation" group experienced a DLT, and 3 out of 6 participants in the "Sunitinib 37.5 mg (2 weeks on, 2 weeks off)" group experienced a DLT. The reported data also includes measurements of how the drugs moved through participants' bloodstreams (for example, peak blood levels and the time taken to reach those peaks), but these figures are presented as technical pharmacokinetic values and are not summarised here in further detail beyond noting they were collected and reported for the expansion group receiving sunitinib 25 mg combined with S-1 and cisplatin. It is important to note that this was a small, early-phase trial designed to explore dosing rather than to draw broad conclusions, and the numbers involved were very small. 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 ↗

  • NCT00447330 · results posted 28 January 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people with previously untreated advanced cancer of the oesophagus or stomach (known as metastatic esophagogastric adenocarcinoma). All 60 participants received the same combination of three medicines: capecitabine (Xeloda), oxaliplatin, and bevacizumab (Avastin). The trial was measuring how long participants went without their cancer getting worse, how long they survived overall, how many experienced a measurable shrinkage in their cancer, and how many experienced side effects. Fifty-eight of the 60 participants completed the study. The reported data shows that the median time before participants' cancer progressed — meaning the point at which half of the participants had seen their disease worsen or had died — was approximately 6.97 months. The median overall survival — the point at which half of the participants had passed away — was reported as approximately 10.51 months. (These "median" figures are simply the midpoint result for the group, not a prediction for any individual.) Regarding tumour response, the reported data shows that approximately 41.7% of participants had their cancer shrink by a meaningful amount (either disappearing completely or reducing in size by at least 30%). In terms of side effects, the reported data shows that 56 out of 60 participants experienced at least one adverse event, though the data as reported does not break down the nature or severity of those events. 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 ↗

  • NCT01041404 · results posted 5 November 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01041404) enrolled 290 people in one group and 294 in another — a total of 584 participants. All participants had a type of stomach or gastro-oesophageal cancer that tests showed to be HER2-positive (meaning the cancer cells carry a particular protein). One group received a chemotherapy combination of fluoropyrimidine and cisplatin (referred to here as FP), while the other group received that same chemotherapy combination plus an additional medicine called trastuzumab (FP + H). The main thing the trial was measuring was overall survival — that is, how long participants lived from the point they were randomly assigned to a treatment group. The reported data shows that, for the primary measure of overall survival, 62.8% of participants in the FP-only group and 56.8% in the FP + trastuzumab group had died by the time data were recorded. For a secondary measure — how long before the disease got worse or a participant died (called progression-free survival) — the reported data shows a median time (the midpoint, meaning half the participants reached this point sooner and half later) of 5.5 months in the FP group and 6.7 months in the FP + H group. A related measure, looking only at how long before the disease progressed (not including death), showed a median of 5.6 months for FP and 7.1 months for FP + H. The reported data also shows that 34.5% of the FP group and 47.3% of the FP + H group had their tumours shrink significantly or disappear entirely during the 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 ↗

  • NCT00917384 · results posted 16 October 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00917384) enrolled 355 people in total — 238 in the ramucirumab (IMC-1121B) group and 117 in the placebo group. The trial was measuring how long participants lived overall, how long they went without their disease getting worse, and several other outcomes including quality of life. Participants received at least one dose of the study drug or placebo, and the large majority completed the study. The reported data shows that, on average, participants in the ramucirumab group lived for 5.2 months from the time they joined the trial, compared with 3.8 months in the placebo group. For "progression-free survival" — meaning the time until the disease got worse or death occurred, whichever came first — the reported figures were 2.1 months for the ramucirumab group and 1.3 months for the placebo group. At the 12-week mark, 40.1% of people in the ramucirumab group had not yet had their disease progress, compared with 15.8% in the placebo group. A small percentage of participants in each group had their tumours shrink noticeably (3.4% in the ramucirumab group versus 2.6% in the placebo group). The reported data for how long those responses lasted was not provided in the submitted results. Quality-of-life scores were measured using a standard questionnaire, and some small changes from starting scores were reported in both groups, though the detailed breakdown across all the questionnaire's individual sections is complex and not straightforward to summarise from the submitted 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00006389 · results posted 1 October 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in a single treatment group, with 11 completing the study and 1 not completing it. The trial was measuring how well a chemotherapy treatment worked against tumours by looking at whether tumours shrank or disappeared, how long participants lived overall, and how long they lived before their disease got worse. The reported data shows that the main goal of the trial — the "response rate" — was 0% of participants. This means that, based on the measurements taken, none of the participants had their tumours shrink by the required amount or disappear completely. For the two secondary measures, the reported data shows that the estimated overall survival (how long participants lived from the start of the trial) was 2.7 months, and the estimated progression-free survival (how long participants lived before the disease was recorded as getting worse) was 1.2 months. These figures are estimates based on a statistical method called Kaplan-Meier, which is a way of calculating average survival times across a group when not all participants have been followed for the same length of time. It is worth noting that only 12 people took part in this trial, which is a very small number, and no figures were reported for any other outcome measures beyond those listed above. 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 ↗

  • NCT01170663 · results posted 31 July 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01170663) enrolled 665 people in total — 330 in the group that received ramucirumab combined with a chemotherapy medicine called paclitaxel, and 335 in the group that received a dummy (placebo) treatment combined with paclitaxel. The trial was set up to measure how long participants lived overall, as well as a number of other things such as how long it took before their disease got worse, and how their tumours responded to treatment. The reported data shows that, for the main measurement — how long participants lived from the time they joined the trial — the ramucirumab-plus-paclitaxel group had a reported median (the midpoint figure, meaning half the group lived longer and half lived less) of 9.6 months, compared with 7.4 months in the placebo-plus-paclitaxel group. For the secondary measurements, the reported median time before disease progression was 4.4 months in the ramucirumab group versus 2.9 months in the placebo group. The median time to disease progression on scans was reported as 5.52 months versus 3.02 months respectively. When looking at tumour responses, about 27.9% of participants in the ramucirumab group showed a complete or partial shrinkage of their tumour compared with 16.1% in the placebo group. Regarding antibodies that the body might develop against ramucirumab, the reported data shows this was detected in 1.6% of participants in the ramucirumab group and 0.3% in the placebo 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 ↗

  • NCT01253525 · results posted 18 June 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received the combination of ramucirumab and paclitaxel and completed the study. The trial was primarily looking at safety-related questions: specifically, whether any participants experienced what are called "dose-limiting toxicities" (serious side effects during the first treatment cycle severe enough to limit or delay dosing), and how many participants experienced adverse events (unwanted health effects) — including serious ones — that were considered related to the study drugs. The reported data shows that none of the 6 participants experienced a dose-limiting toxicity during the first cycle of treatment. All 6 participants were reported to have experienced adverse events of any severity that were considered related to ramucirumab or paclitaxel, and all 6 were reported to have experienced adverse events graded as severe or worse (Grade 3 or above). Regarding deaths related to the study drugs, the reported number was 0. Two out of 6 participants were reported to have experienced serious adverse events considered related to ramucirumab, and 4 out of 6 were reported to have experienced serious adverse events considered related to paclitaxel. The trial also measured how the drug ramucirumab moved through the body. The reported data shows a peak blood concentration of 176 micrograms per millilitre after a single dose, and a total drug exposure figure of 34,100 micrograms-hours per millilitre over time. None of the participants developed detectable antibodies against ramucirumab (which can sometimes reduce how well a drug works). It is worth noting that with only 6 participants, this was a very small study — likely an early-phase trial designed to gather initial information rather than draw broad conclusions. 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 ↗

  • NCT01365130 · results posted 28 April 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 15 people who had a type of stomach or oesophageal cancer (called metastatic gastroesophageal adenocarcinoma) that had already progressed after at least one previous treatment. The trial was testing a drug called cabazitaxel. It set out to measure two things: how many participants did not have their cancer progress within the first three months of treatment, and how many participants experienced side effects (called toxicities) linked to the drug over the course of the trial. The reported data shows that 13 of the 15 participants completed the study, while 2 did not finish. For the main measure, 11 out of the participants were reported as not having disease progression at the three-month mark. For the secondary measure — tracking side effects — the reported data shows that 13 out of 13 participants who completed the study experienced at least one side effect associated with cabazitaxel over an approximate seven-month period. It is worth noting that the data does not describe what types of side effects occurred or how severe they were. The trial did not include a comparison group (such as a placebo or different treatment), meaning all 15 participants received the real drug. Because there was no comparison group, the numbers on their own do not indicate whether outcomes were better or worse than any alternative. The data was not reported in a way that allows for that kind of comparison. 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 ↗

  • NCT00278863 · results posted 25 February 2014

    According to the results reported on ClinicalTrials.gov, this trial compared two oral chemotherapy medicines — S-1 and capecitabine — in people with cancer. Both medicines were given on the same schedule: two weeks on, followed by one week off. A total of 96 people took part, with 49 starting in the S-1 group and 47 in the capecitabine group. The main thing the trial was measuring was the "response rate" — that is, the proportion of participants whose tumours either disappeared completely or shrank by at least 30% during treatment. The reported data shows that in the S-1 group, approximately 28.9% of participants met that response definition, while in the capecitabine group the figure was approximately 26.1%. For the secondary outcome — which tracked how many participants experienced adverse events (unwanted or unexpected health changes noted during the study) — the reported data shows that 42 out of 49 participants in the S-1 group and 44 out of 47 in the capecitabine group had at least one adverse event recorded over up to two years of follow-up. No further breakdown of the types or severity of those adverse events was included 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 ↗

  • NCT00729482 · results posted 13 February 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 54 participants, all of whom received a treatment called RAD001 (also known as everolimus). All 54 participants completed the study. The trial was measuring how the treatment affected cancer progression — specifically, how many people had not seen their cancer grow or spread after four months, how many showed a measurable reduction in tumour size, and how long participants lived overall. The reported data shows that 18.4% of participants (roughly 1 in 5) had not experienced cancer progression at the four-month mark (16 weeks). Progression was defined as tumours growing by more than 20% or new tumours appearing. For the secondary measurements, the response rate — meaning the proportion of participants whose tumours shrank by at least 30% — was reported as 3.7%. The reported median overall survival (that is, the midpoint survival time across the group) was 8.3 months. The reported data also shows that all 54 participants experienced at least one adverse event (an unwanted or unexpected medical occurrence) during the study, though the data as submitted does not break down the type or severity of those events individually. 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 ↗

  • NCT00908960 · results posted 12 December 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total across three groups. Participants were cancer patients who had been tested for a blood-clotting marker called TFMP (tissue factor microparticle). Those with high TFMP levels were either given an anti-clotting injection called enoxaparin (24 people) or simply monitored without treatment (12 people). Those with low TFMP levels were monitored without treatment (34 people). The trial was measuring the likelihood of developing a blood clot in the veins (known as VTE — a clot in the legs or lungs) within two months, as well as serious bleeding events and how long participants survived overall. The reported data shows that, within two months, the estimated probability of developing a blood clot was 5.6% in the high-TFMP group who received enoxaparin, 27.2% in the high-TFMP group who were only observed, and 7.2% in the low-TFMP group who were only observed. For serious bleeding events, the reported data shows that zero participants in any of the three groups experienced a major bleeding event during the study. Regarding overall survival, the reported median survival time (the point at which half of participants had passed away) was 17.8 months for the high-TFMP enoxaparin group, 11.8 months for the high-TFMP observation group, and 17.3 months for the low-TFMP observation group. It is worth noting that this was a relatively small trial with modest numbers in each group, and these figures should be understood as early 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 ↗

  • NCT00496860 · results posted 15 July 2013

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ALT-801 in people with advanced cancers that had spread and were continuing to grow. A total of 26 people took part, split across three groups that each received a different dose of the drug — 4 people in the lowest dose group, 16 in the middle dose group, and 6 in the highest dose group. The trial was primarily measuring how the body tolerated the drug at different dose levels, including whether any serious unwanted reactions occurred or caused someone to have to stop the trial early. The reported data shows that in the lowest dose group, no serious unwanted reactions and no reactions severe enough to cause withdrawal were recorded. In the middle dose group, 2 serious unwanted reactions and 1 withdrawal due to a reaction were reported. In the highest dose group, 4 serious unwanted reactions and 2 withdrawals due to reactions were recorded. For the secondary measures — which looked at how tumours responded — the reported data shows that across all three groups combined, 10 out of 26 participants had tumours that either shrank noticeably, disappeared entirely, or stayed stable rather than growing. The trial also measured activity in certain immune cells in the blood after dosing, with the middle dose group recording the highest level of immune cell activity (9,117 units per million cells measured), compared to 6,433 in the lowest dose group and 1,125 in the highest dose group. The trial additionally measured whether the body produced antibodies against the drug itself, with the middle dose group again showing the highest recorded level. 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 ↗

  • NCT00439608 · results posted 1 July 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 participants, all of whom were in a single treatment group. All 60 participants completed the study — none dropped out. The trial was measuring how well a treatment worked before surgery for cancers of the oesophagus, the gastroesophageal junction (the join between the food pipe and the stomach), or the stomach. Specifically, it was looking at whether there was no detectable cancer remaining in the tissue removed during surgery — called a "pathologic complete response" — and also tracking a common skin side effect called rash. The reported data shows that out of the 60 participants, 40 were recorded as having a pathologic complete response at the time of surgery, meaning no cancer could be detected in the removed tissue at that point. For the secondary outcome, the reported data shows that 37 out of 60 participants experienced a grade 2 or grade 3 rash — where grade 2 means a moderate rash and grade 3 means a more severe rash — which was noted as the most commonly observed side effect in this trial. No other outcome figures were 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 ↗

  • NCT00448760 · results posted 18 February 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 29 participants, all of whom received the same chemotherapy treatment given in two stages — before surgery (neoadjuvant) and after surgery (adjuvant). Twenty-six participants completed the trial, while three did not. The trial was measuring how the cancer responded to treatment, both by examining tissue removed during surgery and by using scans, as well as tracking how long participants lived and how long they went without their cancer getting worse. The reported data shows that the main thing being measured — called a "pathologic complete response," meaning no cancer cells could be found in the tissue removed during surgery — was seen in 16.7% of participants. For the secondary measures, 72.4% of participants showed either a complete or partial response when assessed by scans (meaning their tumours either disappeared entirely or shrank by at least half). The reported data also shows a median progression-free survival — that is, the midpoint value for how long participants went before their cancer worsened — of 13.6 months. The median overall survival (the midpoint value for how long participants lived after joining the trial) was reported as 21.4 months. It is worth noting that these figures come from a single group of 29 people, and no comparison group was included in 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 ↗

  • NCT00365508 · results posted 30 January 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 642 people who smoked — 321 were assigned to use a nicotine patch and 321 were assigned to use a nicotine lozenge. The trial was measuring whether participants had gone without smoking for the 24 hours before their six-month check-in, and also how consistently participants used their assigned nicotine product during the first two weeks of the study. Not everyone finished the trial — 182 people in the patch group and 167 in the lozenge group completed it. The reported data shows that at the six-month follow-up, 50 participants in the nicotine patch group and 35 participants in the nicotine lozenge group reported not having smoked in the 24 hours before that check-in. For the second measure — how consistently people used their product in the first two weeks — the reported data shows that 231 participants in the patch group and 87 participants in the lozenge group were recorded as compliant (meaning they used the product as directed during that period). It is worth noting that these numbers describe what was observed and recorded in this specific group of trial participants. The reported data does not allow conclusions to be drawn about what might happen for any individual person, and no safety or effectiveness conclusions should be drawn from these figures alone. 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 ↗

  • NCT00526669 · results posted 1 October 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 67 participants. The study was designed in two stages: first, all 67 participants took a medicine called lapatinib on its own for seven days (a "run-in" period). After that, all 67 then moved into a combined treatment phase where they took lapatinib together with a second medicine called capecitabine. By the end of the combined phase, 59 participants had completed it and 8 did not. The trial was measuring several things: changes in certain biological markers (proteins and genes) in tumour tissue after the run-in period, the proportion of participants whose tumours shrank (called the response rate), and how long participants went without their disease getting worse. The reported data shows the following numbers. For the biomarker measurements — which looked at the activity of specific genes in tumour tissue before and after the seven-day lapatinib period — the reported ratios (a way of comparing gene activity levels) were 0.38, 0.12, 0.15, 0.01, and 0.87. Regarding tumour response in the combined treatment phase, approximately 17.9% of participants were reported to have had a measurable reduction in their tumour (either a complete or partial response). Around 29% of participants were reported to be alive and progression-free (meaning their disease had not worsened) at the five-month mark. The reported data also shows that the median time participants went without their disease getting worse was about 14.3 weeks, the median time to disease progression (counting only disease worsening, not deaths) was about 18.9 weeks, and the median overall survival (time from the start of treatment until death from any cause) was about 27.6 weeks. It is worth noting that these figures are summary numbers from the group as a whole, and individual experiences within the trial would have varied. No comparison group (such as a placebo or different treatment) was reported in this data, so the numbers reflect what was observed in this single group of participants 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00296322 · results posted 6 September 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 521 people in total — 258 in a group receiving a treatment combination called "Mitomycin and Short-term Fluoropyrimidine," and 263 in a group receiving a combination called "iceMFP." The trial was measuring how long participants went without their cancer returning (called relapse-free survival), how long participants lived overall (overall survival), and what side effects or reactions led people to stop treatment. The reported data shows that for relapse-free survival — meaning the percentage of participants whose cancer had not returned by the end of the follow-up period — 50.0% of people in the Mitomycin and Short-term Fluoropyrimidine group and 60.2% of people in the iceMFP group reached this milestone. For overall survival, the reported figures were 59.6% in the Mitomycin and Short-term Fluoropyrimidine group and 71.2% in the iceMFP group. It is worth noting that more participants in the iceMFP group did not complete the study (79 people, compared to 21 in the other group). Regarding side effects and tolerability, the reported data shows that 13 participants in the Mitomycin and Short-term Fluoropyrimidine group and 30 participants in the iceMFP group stopped their treatment due to unwanted reactions or their own choice. The trial's researchers noted that because side effects in cancer studies are tracked individually for each type of reaction, a single overall figure for all patients cannot be meaningfully presented. 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 ↗

  • NCT01373346 · results posted 31 August 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people who underwent a surgical procedure called a "Long Limb Roux-en-Y Reconstruction" — a type of stomach bypass operation. Fourteen of the 15 participants completed the trial; one did not finish. The trial was primarily measuring how often serious surgical complications occurred after the operation. It also tracked several measures related to how the body handles blood sugar and insulin over time, as well as participants' body weight relative to their height (Body Mass Index, or BMI). The reported data shows that 4 out of 15 participants experienced a serious complication (defined as one requiring more than basic treatment, such as needing further surgery, a blood transfusion, or intensive care). For the blood sugar and insulin-related measurements, the data appears to have been recorded at three separate time points. The reported data shows that one measure of the body's sensitivity to insulin (called the Matsuda Index — a higher number generally means more sensitivity) went from 7.2 at the first time point, to 15.4, and then to 17.1. Another insulin-related measure (HOMA-IR, where a lower number generally reflects less resistance to insulin) went from 2.2 down to 1.0 and remained at 1.0. A measure of insulin-producing cell function (HOMA-B, reported as a percentage) went from 7.7 to 13.4 and then 16.0. A fourth insulin sensitivity score (QUICKI) was reported as 0.4 at all three time points. Average BMI across the group went from 25.2 to 21.7 and then 21.2 across the three measurement points. It is worth noting that because this trial had only one group and no comparison group, the reported figures show changes within the same group of participants over time only. The data does not include a breakdown of individual time points by label, so the exact timing of each measurement 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00335959 · results posted 17 August 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 7 people in total, all of whom went through a combined treatment pathway involving chemotherapy, chemoradiation (chemotherapy given alongside radiotherapy), and surgery. Six of the seven participants were confirmed eligible and began the planned treatment, while four completed the full study. The trial was looking at a specific type of stomach cancer (gastric adenocarcinoma) and measuring whether the treatment could wipe out all detectable cancer cells in the removed tissue before surgery — a result known as a "pathologic complete response," meaning no cancer could be found by the pathologist in the stomach tissue or nearby lymph nodes after the specimen was examined. The reported data shows that, for the primary goal of pathologic complete response, results were recorded across five measurement points, with values of 1, 2, 2, 1, and 1 participants respectively. The data as submitted does not provide a single clear summary figure (such as a total percentage), so a straightforward overall rate cannot be stated here beyond what was reported. For the secondary outcome — which tracked how many participants experienced serious or severe side effects (graded as severe, life-threatening, or fatal under a standard medical rating scale) — the reported data shows counts across twelve different types of adverse events, with numbers ranging from 1 to 2 participants affected for each event type. Because the data was submitted as individual event-type counts rather than a single total, the exact breakdown of what each event was is not available from the structured data provided. It is worth noting that this was a very small trial with only 7 participants, and the data as reported on ClinicalTrials.gov does not include a narrative summary of the overall findings. 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 ↗

  • NCT00400179 · results posted 23 April 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00400179) enrolled 1,053 people in total — 527 in the S-1/Cisplatin group and 526 in the 5-FU/Cisplatin group. Participants were randomly assigned to receive one of these two chemotherapy combinations, and the trial was measuring how long people lived overall, as well as a number of other markers such as how many people's tumours shrank, and how long it took before the disease got worse. The reported data shows that the main measure — median survival time (that is, the point at which half of participants in a group had died) — was 8.6 months for the S-1/Cisplatin group and 7.9 months for the 5-FU/Cisplatin group. For the secondary measures, the proportion of patients whose tumours shrank noticeably (the "overall response rate") was reported as 29.1% for S-1/Cisplatin and 31.9% for 5-FU/Cisplatin. Among those whose tumours did shrink, that shrinkage lasted a reported 6.5 months on average in the S-1/Cisplatin group and 5.8 months in the 5-FU/Cisplatin group. The time from the start of the trial until the disease was first recorded as getting worse (progression-free survival) was reported as 4.8 months for S-1/Cisplatin and 5.5 months for 5-FU/Cisplatin. The time until treatment was stopped or disease worsened (time to treatment failure) was 3.8 months 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 ↗

  • NCT00555620 · results posted 5 September 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total across six different treatment groups. Each group received a different combination of doses of three medicines — sunitinib (SU), and either cisplatin (CIS) or oxaliplatin (OXA), plus capecitabine (CAP). The trial was primarily measuring how many participants in each group experienced serious side effects during the first treatment cycle, known as "dose-limiting toxicities" (DLTs) — meaning side effects severe enough that they would limit how much of the medicine could be given. The reported data shows that none of the participants were recorded as having "completed" the study in the formal sense, with all participants listed under "not completed," though this likely reflects how the trial's progress was tracked rather than dropout alone. Regarding the primary outcome, the reported data shows that the number of participants who experienced these first-cycle dose-limiting toxicities varied by group. In the group receiving SU 37.5 mg with CIS 60 mg/m² and CAP 1,600 mg/m², 1 out of 6 participants had a DLT. In the group receiving SU 37.5 mg with CIS 60 mg/m² and CAP 2,000 mg/m², 0 out of 7 did. In the group receiving SU 25 mg with CIS 80 mg/m² and CAP 2,000 mg/m², 3 out of 15 did. Among the oxaliplatin groups, 2 out of 23 participants had a DLT with SU 37.5 mg and CAP 1,600 mg/m²; 2 out of 3 did with SU 37.5 mg and CAP 2,000 mg/m²; and 0 out of 22 did with SU 25 mg and CAP 2,000 mg/m². The reported data also includes measurements of how much of each medicine and its breakdown products were found in participants' blood (only reported for three of the six groups). These blood-level figures were recorded in nanograms per millilitre and varied across the groups and substances measured — for example, the peak blood level of sunitinib itself ranged from around 40 to 70 ng/mL across those three groups. The full breakdown of all blood-level measurements for the other three groups was not reported 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00033657 · results posted 19 July 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 97 people in total (50 in one group and 47 in the other) who had oesophageal cancer. Participants were divided into two treatment groups: one group (Arm A) received a combination of cisplatin, irinotecan, and radiation therapy, while the other group (Arm B) received paclitaxel, cisplatin, and radiation therapy. The trial was measuring whether, after surgery, any traces of cancer could still be found in the removed tissue — as well as how long participants lived overall and how long they went without the cancer coming back. The reported data shows that for the main measure — finding no remaining cancer in the surgically removed tissue — around 15% of participants in Arm A and around 17% in Arm B reached that result. For overall survival (how long participants lived from the time they joined the study), the reported middle-point figure was 35 months for Arm A and 21 months for Arm B. For recurrence-free survival (how long participants went without the cancer returning, measured from the point of their best response), the reported middle-point figure was approximately 40 months for Arm A and 12 months for Arm B. It is worth noting that these middle-point figures represent the point at which half the participants in each group had experienced the relevant event — they do not describe any individual person's experience. 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 ↗

  • NCT00411151 · results posted 14 January 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people, all of whom received the drug sunitinib. Only 5 participants were recorded as completing the trial, while 47 did not complete it. The trial was measuring how well sunitinib shrank tumours in participants within the first 6 treatment cycles, and also tracked how long participants went without their disease getting worse, how long they survived overall, and what unwanted health events occurred during the trial. The reported data shows that roughly 3.92% of participants had their tumours shrink enough to count as a confirmed response (meaning either the tumour disappeared completely or shrank by at least 30%). On average, participants went approximately 39 days before their disease progressed or they passed away — this is referred to as "progression-free survival." The reported median overall survival — that is, the point by which half of participants had died — was approximately 177 days. Around 23.7% of participants were still alive at the one-year mark. Regarding unwanted health events, the reported data shows that all 52 participants experienced at least one adverse event (an unwanted health occurrence during the trial), and 26 of the 52 participants experienced at least one "serious adverse event" — meaning a more significant health event that required closer attention. 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 ↗

  • NCT00555672 · results posted 5 January 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people in total — 24 in a group receiving a lower dose of sunitinib (25 mg) combined with two chemotherapy drugs (cisplatin and 5-FU), and 10 in a group receiving a higher dose of sunitinib (37.5 mg) with the same chemotherapy drugs. The trial was primarily looking at how many participants experienced what researchers call "dose-limiting toxicities" (DLTs) — that is, side effects serious enough during the first 21-day treatment cycle to limit how much of the drug combination could be given. The trial also tracked how the drugs moved through participants' bodies by measuring drug levels in the blood over time. The reported data shows that in the first treatment cycle, 1 out of 24 participants in the lower-dose sunitinib group experienced a dose-limiting toxicity, while 0 out of 10 participants in the higher-dose group did. It is worth noting that none of the participants were recorded as having "completed" the study under the trial's own definitions. For the lower-dose group only, the reported data shows that sunitinib reached a peak blood concentration of 16.8 nanograms per millilitre, and the steady-state blood concentration of the chemotherapy drug 5-FU was reported as 593 nanograms per millilitre. The time at which sunitinib reached its peak level in the blood was reported as 4 hours after dosing. Blood-level data for the higher-dose group was 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT00320515 · results posted 28 September 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people, all of whom received a combination of two chemotherapy medicines — pemetrexed and cisplatin. The trial was measuring how tumours responded to this treatment combination, as well as how long any response lasted, how long participants lived without their disease getting worse, and how long participants lived overall. Of the 69 people who started the trial, 20 completed it and 49 did not complete it (the reasons were not detailed in the data provided here). The reported data shows the following tumour responses among participants: 1 person had a complete response (all detectable tumour lesions disappeared), 15 had a partial response (tumours shrank by at least 30%), 22 had stable disease (tumours neither shrank enough to count as a response nor grew enough to count as progression), 24 had progressive disease (tumours grew by at least 20%), and 6 participants' responses were recorded in a category not further described in the submitted data. For the secondary outcomes, the reported data shows that among those who had a complete or partial response, the response lasted a median (middle value) of 5.4 months. The median time before the disease got worse or a participant died was reported as 4.9 months, and the median overall survival — from enrolment to death — was reported as 11.8 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 ↗

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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.