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Reported trial results for Kidney Cancer

Every Kidney 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.

105 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

  • NCT03294083 · results posted 18 June 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT03294083) enrolled 95 people in total across six groups. The early phase (Part 1) tested two different doses of a treatment called Pexa-Vec given by intravenous drip (into a vein), with 3 people in each dose group. The larger phase (Part 2) tested four different treatment approaches across four arms: Pexa-Vec injected directly into tumours combined with another drug called cemiplimab (15 people); cemiplimab alone (16 people); Pexa-Vec by drip combined with cemiplimab at one dose level (30 people); and Pexa-Vec by drip combined with cemiplimab at another dose level (28 people). The trial was measuring things like how participants' bodies responded to the treatments, whether tumours shrank, and how long participants lived or went without their disease getting worse. The reported data shows that in Part 1, none of the 6 participants experienced what the researchers defined as a "dose-limiting toxicity" (a side effect serious enough to set a ceiling on the dose). For adverse events (unwanted health effects recorded during the study) across the main Part 2 groups, the reported numbers of participants experiencing these ranged from 6 to 13 people per group depending on the type of event being counted. For tumour response — meaning the proportion of people whose tumours shrank noticeably — the reported figures were: 13.3% in the tumour-injection plus cemiplimab group, 12.5% in the cemiplimab-only group, 23.3% and 17.9% in the two drip-plus-cemiplimab groups. The proportion of participants whose disease either shrank or stayed stable (called "disease control rate") ranged from about 56% to 68% across the Part 2 groups. Median time before disease got worse or death occurred (progression-free survival) ranged from roughly 4.3 to 6.3 months across Part 2 groups, while median overall survival ranged from approximately 19 to 25 months. Survival figures for the Part 1 groups were not reported in the 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 ↗

  • NCT04941768 · results posted 28 November 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 105 participants, all of whom received a combination of two medicines — avelumab and axitinib — for advanced kidney cancer (renal cell carcinoma). All 105 participants were recorded as having completed the study. The trial was primarily measuring how many participants were still alive 12 months after starting treatment, and it also tracked a range of secondary measures including survival at 24 months, how long participants lived overall, how many participants' tumours shrank or disappeared, how many had their disease stabilise or improve, and how long those responses lasted. The reported data shows that, at the 12-month mark, 82.7% of participants were recorded as still alive. At 24 months, the reported figure was 73.1%. When it came to tumour response, 48.4% of participants were reported to have had their tumours either completely disappear or shrink by a meaningful amount. A broader measure — which also included participants whose disease stayed stable rather than growing — showed 80.2% of participants falling into that category. Two figures were listed as "NA" (not available) in the submitted data: the median length of time participants survived overall, and the median length of time that tumour responses lasted. The reported data does not include these numbers, so they 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 ↗

  • NCT04320888 · results posted 6 November 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04320888) enrolled just one paediatric (child or adolescent) participant who received a medicine called selpercatinib. The trial was designed to measure how many participants showed a measurable reduction in their tumour (known as an "objective response"), how long they went without their disease getting worse (called "progression-free survival"), and what proportion experienced serious side effects (graded 3 or 4 out of 5 in severity, meaning significant or severe). The reported data shows that 100% of participants — that is, the single participant in the study — met the criteria for a tumour response (either a complete or partial reduction in tumour size) according to a standardised measurement tool called RECIST. The reported data also shows that 100% of participants were still free from disease progression or death at the 6-month mark. Regarding serious side effects, the reported figure was 0% of participants experiencing grade 3 or 4 adverse events. For the additional planned measure looking at changes in tumour genetics over time, no results data was reported. It is important to note that because only one person participated in this trial, these percentages represent the outcome of a single individual and cannot be used to draw broader 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 ↗

  • NCT03937219 · results posted 10 September 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03937219) enrolled 855 people in total — 428 in a group receiving cabozantinib combined with two immunotherapy medicines (nivolumab and ipilimumab), and 427 in a group receiving a placebo combined with the same two immunotherapy medicines. The trial was measuring two main things: how long participants went without their disease getting worse (called progression-free survival), and how long participants lived overall (called overall survival). The reported data shows that for progression-free survival — the time from when a person joined the trial until their disease progressed or they died — the placebo-plus-immunotherapy group had a reported median of 11.30 months. A "median" here means the midpoint: half of the people in that group reached that time point or beyond. For the cabozantinib-plus-immunotherapy group, this figure was listed as "NA" (not available), meaning a median result was not reported in the submitted data. For overall survival — how long participants lived from the time they joined the trial — the reported median was 41.86 months for the cabozantinib group and 41.99 months for 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 ↗

  • NCT04508725 · results posted 25 July 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04508725) enrolled a total of 19 people across three groups. Twelve participants were in Arm 1, which received a combination of two types of targeted cancer medicines (a tyrosine kinase inhibitor and an immune checkpoint inhibitor — drugs that work on different parts of cancer cell growth and the immune system). Five participants were in Arm 2, which received a different treatment not involving an immune checkpoint inhibitor. Two participants were in Arm 3, meaning they took part in both arms one after the other. The trial was measuring how tumours responded to these treatments at an early check-in point, roughly 8 to 16 weeks after starting treatment. The reported data shows that for Arm 1 (the combination treatment), 5 out of 12 participants showed a meaningful shrinkage of their tumour (recorded as either a complete or partial response) at that first check-in. For Arm 2 (the non-immune therapy), 1 out of 5 participants showed that level of response. For the 2 participants who took part in both arms consecutively, neither showed that level of response in their first participation, while 1 did in their second. The reported data also shows changes in overall tumour size: in Arm 1, tumours measured on average about 16% smaller compared to the starting point, while in Arm 2 tumours measured on average about 44% larger. For the two participants in Arm 3 during their second participation, tumours measured on average about 21% smaller. When looking at individual tumour spots rather than the overall picture, Arm 1 showed an average reduction of around 28%, Arm 2 showed an average reduction of around 5%, and Arm 3 (second participation) showed an average reduction of around 6%. 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 ↗

  • NCT02711202 · results posted 4 June 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 kidney transplant recipients in total — 7 people received sirolimus and 13 received tacrolimus. Both are medicines used after a transplant to stop the body rejecting the new kidney. The trial was measuring whether patients stayed alive, whether their transplanted kidney continued to work, and how well that kidney was functioning at one year after the transplant. The reported data shows that all 7 patients in the sirolimus group and all 13 in the tacrolimus group were recorded as alive at the end of the study. Six out of 7 sirolimus patients and all 13 tacrolimus patients were reported to have a working transplanted kidney. For kidney function, the trial measured a substance in the blood called creatinine — higher levels suggest the kidney is not filtering as well. The reported average creatinine level at one year was 144.4 µmol/L in the sirolimus group and 110 µmol/L in the tacrolimus group. Regarding a type of low-level rejection that causes no obvious symptoms (called subclinical rejection, confirmed by a tissue sample from the kidney), the data shows this was recorded in 4 sirolimus patients and 2 tacrolimus patients over the first year. A separate biopsy taken specifically at the 12-month mark found subclinical rejection signs in 1 sirolimus patient and 2 tacrolimus patients. It is also worth noting that 4 participants in the sirolimus group did not complete the study, while all 13 tacrolimus participants did; the reasons were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT03138512 · results posted 18 December 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03138512) looked at treatments for kidney cancer (renal cell carcinoma) after surgery. It was split into two parts. In Part A, around 404 people received a combination of two medicines called nivolumab and ipilimumab, and about 407 people received a placebo (an inactive treatment). In Part B, roughly 204 people received the combination, 208 received a placebo, and 411 received nivolumab on its own. In total, over 1,600 people took part across the two parts. The trial was mainly measuring how long people went without their disease coming back or spreading (called "disease-free survival"), and also tracked how long people lived overall. The reported data shows that for the main measure — how long people remained disease-free — the results were listed as "NA" (not available or not yet reached), meaning a final median time figure was not reported in the submitted data for any of the groups. Similarly, overall survival figures expressed as a length of time were also listed as "NA" across all groups. The one survival figure that was reported was the percentage of people still alive at five years: in Part A, approximately 85.0% of those who received the combination treatment were reported as alive at five years, compared with approximately 87.2% of those who received the placebo. No five-year survival percentages were reported in the submitted data for the Part B groups. Regarding unwanted side effects in Part A, the reported data shows that 392 out of 404 people in the combination group experienced some kind of adverse event (an unwanted medical occurrence), compared with 362 out of 407 in the placebo group. More serious adverse events (graded as severe or higher) were reported in 154 people in the combination group versus 44 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 ↗

  • NCT01693822 · results posted 21 November 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people, all of whom were in a single group receiving a medicine called axitinib. All 65 participants completed the study. The trial was primarily looking at how many people were still alive and had not seen their cancer grow or spread by the six-month mark. It also tracked a number of secondary measures, including how tumours responded to treatment, how long it took for the cancer to progress, how long participants lived overall, side effects experienced, and how many people became suitable for surgery to remove their kidney (nephrectomy) as a result of taking the medicine. The reported data shows that 58.5% of participants were alive and free from cancer progression at six months. When it came to tumour response — meaning how the tumour appeared to change during treatment — 1 person had a complete response (no detectable tumour), 19 had a partial response (tumour shrank), 29 had stable disease (tumour neither shrank nor grew significantly), and 16 had progressive disease (tumour grew). The reported median time without cancer progression was 63.1 months (median means half the participants reached this point sooner, and half took longer). The reported median overall survival — meaning the midpoint for how long participants lived from the start of the trial — was 19.7 months. Regarding side effects, the reported data shows 26 participants experienced serious adverse events, 62 experienced non-serious adverse events, and 3 experienced what were described as other adverse events. Nine participants became suitable for and underwent nephrectomy following treatment with axitinib. 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 ↗

  • NCT02684006 · results posted 29 October 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 886 people with kidney cancer — 442 received a combination of two medicines called avelumab and axitinib, and 444 received a medicine called sunitinib. 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 (objective response). Some results were reported specifically for participants whose tumours tested positive for a protein called PD-L1, and some results covered all participants regardless of that test. The reported data shows the following numbers for participants whose tumours were PD-L1 positive: the median time before disease worsening was 13.8 months in the avelumab-plus-axitinib group compared with 7.2 months in the sunitinib group; the median overall survival was 43.2 months versus 36.2 months respectively. (Median means half the participants in that group had a result above this number and half below.) When looking at all participants regardless of PD-L1 status, the reported median time before disease worsening was 13.8 months for avelumab-plus-axitinib versus 8.4 months for sunitinib, and median overall survival was 44.8 months versus 38.9 months. The reported data also shows that, across all participants, the proportion whose tumours shrank or disappeared was 51.4% in the avelumab-plus-axitinib group compared with 25.7% in the sunitinib group, based on independent central review; a separate assessment by the treating investigators recorded 59.7% versus 32.0% respectively. It is worth noting that none of the participants were recorded as having formally "completed" the trial under the study's own definition, 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.

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

  • NCT03849118 · results posted 17 May 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 300 participants, all of whom received an investigational imaging agent called 89Zr-girentuximab (also referred to as 89Zr-TLX250). Of those, 275 completed the trial and 25 did not complete it. The trial was measuring how well a specialised type of scan — called a PET/CT scan — could identify a specific type of kidney tumour known as clear cell renal cell carcinoma (ccRCC) in people who had an uncertain or "indeterminate" mass on their kidney. The scan results were then compared against tissue analysis (histology), where a sample of the mass was examined under a microscope after surgical removal, which served as the definitive reference point. The reported data shows the primary outcome measured four groups of participants based on how the scan results compared to the tissue analysis. According to the results reported on ClinicalTrials.gov, 84 participants were recorded in one category, 11 in another, 30 in a third, and 159 in a fourth. These four numbers represent the breakdown of how scan findings matched or did not match the tissue results — for example, cases where the scan correctly identified a tumour, cases where it did not, and so on — however, the specific labels for each of these four categories (such as true positives, false positives, and so on) were not fully detailed in the submitted data. No additional secondary outcome data was 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 ↗

  • NCT04148937 · results posted 5 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04148937) enrolled 52 people in total across eight groups. Participants were divided into two broad cohorts: Cohort A received the investigational drug LY3475070 on its own at different doses and schedules, and Cohort B received LY3475070 combined with another drug called pembrolizumab, again at different doses and schedules. The trial was primarily measuring how many participants experienced what are called "dose-limiting toxicities" (DLTs) — that is, serious unwanted reactions considered severe enough to be linked to the study drug and that would signal a dose was too high to continue with safely. The reported data shows that across all four groups in Cohort A (doses ranging from 150 mg once daily up to 600 mg once daily), zero out of 20 participants recorded a dose-limiting toxicity. In Cohort B, one participant out of 11 in the 150 mg twice-daily-plus-pembrolizumab group, one out of 1 in the 300 mg once-daily-plus-pembrolizumab group, and one out of 17 in the 300 mg twice-daily-plus-pembrolizumab group each recorded a dose-limiting toxicity; the remaining group (150 mg once daily plus pembrolizumab, 3 participants) recorded zero. The reported data also shows results for several secondary measures. For tumour response, zero percent of participants across all eight groups showed a complete or partial shrinkage of their tumour (known as Overall Response Rate). When "stable disease" — meaning the tumour neither grew nor shrank significantly — was included alongside those responses (called Disease Control Rate), the figures ranged from 0% to 66.7% depending on the group, with the 150 mg once-daily-plus-pembrolizumab group (Cohort B) recording the highest figure of 66.7%. The trial also measured how the drug moved through the body (called pharmacokinetics), recording how much drug was present in the blood and what peak levels were reached; these figures varied across groups and doses, and for the 300 mg once-daily-plus-pembrolizumab group, this data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04489771 · results posted 28 February 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04489771) enrolled 154 adults in total — 78 who received a 200 mg dose of a medicine called belzutifan, and 76 who received a 120 mg dose. The trial was measuring how the tumours in these participants responded to treatment, using a standard set of imaging-based rules called RECIST 1.1. A review panel that did not know which dose each participant received (called a "blinded independent central review") assessed the scans. No participants were recorded as having formally "completed" the study by the time data was submitted, meaning the trial was still ongoing or participants had left for other reasons before a defined end-point. The reported data shows that the main thing being measured — the proportion of participants whose tumours shrank by a meaningful amount (called the "objective response rate") — was 23.1% in the 200 mg group and 23.7% in the 120 mg group. For secondary measures, the reported data shows that the time participants went without their disease worsening ("progression-free survival") was 9.1 months in the 200 mg group and 7.3 months in the 120 mg group. Among those whose tumours did shrink, the length of time that response lasted ("duration of response") was reported as 16.1 months in the 200 mg group; this figure was not reported for the 120 mg group. The proportion of participants who had either a tumour shrinkage or whose disease stayed stable for at least 6 months ("clinical benefit rate") was 41.0% in the 200 mg group and 47.4% in the 120 mg group. Overall survival figures (how long participants lived from the start of the trial) were not yet reported for either group. The reported data also shows that 77 out of 78 participants in the 200 mg group and 75 out of 76 in the 120 mg group experienced at least one adverse event (an unwanted medical occurrence during the study period); the nature or severity of those events is not detailed in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT04338269 · results posted 28 February 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04338269) enrolled 522 people in total — 259 in the cabozantinib-only group and 263 in the group receiving atezolizumab plus cabozantinib combined. The trial was measuring two main things: how long participants went without their cancer growing or spreading (called progression-free survival), and how long participants lived overall (called overall survival). It also looked at secondary measures including what proportion of participants saw their tumours shrink (response rate) and how long those responses lasted. The reported data shows that for the primary measure of time without disease progression, as assessed by an independent review panel, the cabozantinib-only group recorded a median of approximately 10.8 months, and the combination group recorded approximately 10.6 months. When investigators assessed the same measure themselves, the figures were similar — about 10.4 months for cabozantinib alone and 10.4 months for the combination. For overall survival, the reported median for the combination group was approximately 25.7 months; a corresponding median figure for the cabozantinib-only group was not reported in the data (listed as "NA," meaning it had not been reached or was not calculable at the time of analysis). For tumour shrinkage, the reported response rates were roughly 42% (cabozantinib alone) versus 38% (combination) by investigator assessment, and approximately 41% versus 41% by independent review. The reported median duration of response for cabozantinib alone was about 12.2 months; a corresponding figure for the combination group was not reported in the 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 ↗

  • NCT04021238 · results posted 13 November 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04021238) enrolled 24 participants, all of whom completed the study with no drop-outs. The trial involved a single group of people who received an ultrasound contrast agent called Perflutren Lipid Microsphere (a substance injected into the body to make ultrasound images clearer). The goal was to measure specific image-based characteristics of kidney masses — that is, growths or lumps found on the kidney — using a specialised type of ultrasound called contrast-enhanced ultrasound (CEUS). The researchers were trying to build a model that might help distinguish between different types of kidney tumours based on how the contrast agent flows in and out of the mass over time. The reported data shows six measurements were taken from the ultrasound images. These measurements tracked how the brightness of the image changed as the contrast agent entered and left the kidney mass. The "wash-in slope" — how quickly the image brightened as the contrast arrived — was reported as 7.60 units per second. The "wash-in intercept" — a calculated starting point for that brightening — was reported as −18.30 units. The "wash-out slope" — how quickly the image darkened as the contrast cleared — was reported as −0.93 units per second, with a corresponding "wash-out intercept" of 125.84 units. Two additional measurements, called FR_a and FR_beta, which describe the overall shape and rate of the brightness curve using a different mathematical approach, were reported as 102.84 units and 0.16 units per second 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 ↗

  • NCT03824808 · results posted 25 October 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people in total — 11 in the Treatment Group and 10 in the Control Group. All 21 participants completed the study with no dropouts. The trial was measuring post-operative pain and a range of other recovery-related outcomes after surgery, including how much pain relief medication people needed, how long they stayed in hospital, and how quickly their digestive system returned to normal. The reported data shows that for the main outcome — pain scores rated on a scale of 0 (no pain) to 10 (worst pain ever) — both groups reported scores across several time points that ranged roughly from around 2 to 5.5 out of 10. The Treatment Group's scores ranged from 5.5 down to 2.3 across the measured time points, while the Control Group's ranged from 4.0 down to 1.9. For painkiller use in the first 24 hours after surgery, the reported data shows the Treatment Group used an average of 22.5 milligrams of morphine equivalent compared to 12.0 in the Control Group. The reported time spent in the post-surgery recovery room was 59 minutes for the Treatment Group and 122.5 minutes for the Control Group. For some of the secondary measurements — including the opioid data beyond the first 24 hours — not all paired group figures were clearly reported in the submitted data. The data on post-operative bowel-related outcomes (passing wind, bowel slowdown) showed very small numbers across both groups, consistent with the small overall trial size. It is worth noting that with only 21 participants across both groups, this was a very small trial, and the reported numbers on ClinicalTrials.gov represent a limited snapshot. 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 ↗

  • NCT02855203 · results posted 3 August 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02855203) enrolled 30 participants, all of whom completed the study. Every participant received the same combination treatment: SABR (a precise, high-dose form of radiation therapy) together with a drug called pembrolizumab (an immunotherapy medicine). The trial was looking at side effects from the treatment, as well as several measures related to how participants' cancer responded and progressed over time. The reported data shows that 4 out of 30 participants experienced what are described as "Grade 3 treatment-related adverse events" — meaning serious side effects considered linked to the treatment, rated on a standard scale where Grade 3 represents high-severity reactions. For the secondary measurements, the reported data shows that 74% of participants were alive at the time of follow-up (overall survival), and 92% had no worsening of their cancer at the site that was treated with radiation (freedom from local progression). Across the body more broadly, 52% of participants had no sign of their cancer spreading to new areas (distant progression-free survival). When looking at overall tumour response using a standard measurement tool, 63% of participants showed either a complete disappearance or a meaningful shrinkage of their target tumours. Separately, 22 out of 30 participants reported at least one pain score above zero on a 0–10 pain scale at some point after treatment; the data does not report individual pain scores beyond this count. 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 ↗

  • NCT03024996 · results posted 3 August 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03024996) enrolled 778 people who had been treated for kidney cancer (renal cell carcinoma) and were at risk of it returning. Participants were randomly assigned to receive either atezolizumab (390 people) or a placebo — an inactive lookalike treatment (388 people). The trial's main goal was to measure "disease-free survival," which means how long participants went without their cancer coming back or dying from any cause. The reported data shows that, for the primary outcome of investigator-assessed disease-free survival, the atezolizumab group had a reported median of 57.2 months, compared with 49.5 months in the placebo group. (A "median" here means the midpoint — half of participants in each group reached that time point without an event, and half did not.) In a subgroup of participants whose tumour tissue showed a certain protein marker (called PD-L1 IC1/2/3, meaning at least 1% of immune cells in the tumour expressed this protein), the reported figures were 57.2 months for the atezolizumab group and 47.9 months for the placebo group. For several other secondary outcomes — including overall survival (how long participants lived overall), an independent review of disease-free survival, and a related measure called event-free survival — the data was not reported as a numeric figure 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.

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

  • NCT03729245 · results posted 11 April 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03729245) enrolled 623 people with previously untreated advanced kidney cancer (renal cell carcinoma). Participants were split into two groups: 311 people received a combination of two medicines called bempegaldesleukin and nivolumab, while 312 people received one of two standard medicines, sunitinib or cabozantinib. The trial was measuring how many people's tumours shrank or disappeared (called the objective response rate), how long people lived overall, and how long people went without their disease getting worse. The reported data shows that, looking at tumour shrinkage or disappearance, 73 out of 311 people in the combination group responded, compared with 109 out of 312 people in the standard medicine group. In a subgroup of patients considered at intermediate or poor risk, 59 people in the combination group responded versus 79 in the standard medicine group. For overall survival — how long people lived — the reported data shows the figures were listed as "NA" (not available/not reached) for most groups at the time of reporting, meaning a final number could not yet be calculated; however, one figure of 29 months was reported for the intermediate- or poor-risk patients in the combination group. For the secondary measure of how long people went without their disease worsening, the combination group reported 8.2 months (all-risk patients) and 6.4 months (intermediate- or poor-risk patients), compared with 10.3 months and 9.2 months respectively in the standard medicine 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 ↗

  • NCT03428217 · results posted 20 March 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03428217) enrolled 444 people in total — 223 in one group (called "Pbo-Cabo") and 221 in the other (called "CB-Cabo"). Both groups went on to receive a drug called cabozantinib; the difference between the groups was what they received beforehand. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), as judged by an independent panel of radiology experts reviewing scans. It also measured how long participants lived overall, and how long they went without disease worsening as judged by the treating doctors. The reported data shows that, for the main measure — time without disease worsening as assessed by the independent panel — the Pbo-Cabo group had a median (the midpoint value, where half of participants fell above and half below) of 9.33 months, and the CB-Cabo group had a median of 9.17 months. For overall survival, the reported median was 24.84 months in the Pbo-Cabo group and 22.24 months in the CB-Cabo group. When the treating doctors (rather than the independent panel) assessed disease worsening, the reported median was 8.38 months for the Pbo-Cabo group and 9.17 months for the CB-Cabo group. No participants were recorded as having formally "completed" the study, which the reported data does not explain further. It is worth noting that the data as submitted does not include any statistical comparison figures between the two groups, so no conclusions about differences between them can be drawn from the numbers 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 ↗

  • NCT03149003 · results posted 30 January 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03149003) enrolled people with a type of brain tumour called glioblastoma (GBM) that had come back or continued to grow after initial treatment. A total of 221 participants took part across two phases. A small first phase (4 people) tested a combination of an investigational treatment called DSP-7888 Dosing Emulsion together with a medicine called bevacizumab, mainly to look at serious side effects. The larger second phase (217 people) then compared that combination against bevacizumab on its own, with participants split roughly equally between the two groups. The trial was primarily measuring how long participants lived overall, and also tracking how long their disease stayed stable before worsening. The reported data shows the following numbers for the main phase of the trial. For overall survival — meaning how long participants lived from the start of the study — the group receiving the combination treatment had a reported median (the midpoint figure, where half lived longer and half shorter) of 10.2 months, compared with 9.4 months for the bevacizumab-only group. At the 12-month mark, the reported data shows that approximately 37.9% of people in the combination group and 31.6% in the bevacizumab-only group were still alive. For how long the disease stayed stable before worsening (called progression-free survival), the reported median was 5.3 months in the combination group and 3.8 months in the bevacizumab-only group. At 6 months, roughly 36.3% of the combination group and 35.4% of the bevacizumab-only group had not yet experienced worsening. The proportion of participants whose tumour showed a measurable reduction was reported as 21.1% in the combination group and 13.0% in the bevacizumab-only group. In the small first phase, zero out of 4 participants were reported to have experienced a serious predefined side effect threshold (called a dose-limiting toxicity). 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 ↗

  • NCT02996110 · results posted 19 December 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02996110) tested five different two-drug combinations in people with cancer. All combinations included nivolumab paired with one of four other medicines: ipilimumab, relatlimab, BMS-986205, or BMS-813160 (at either a 150 mg or 300 mg dose). The trial had two tracks, and some participants moved between tracks or were re-assigned to a different combination during the study. In total, across all five groups, roughly 182 people entered the pre-treatment phase, with between 17 and 65 participants starting in each group. The reported data shows the following for the main things being measured. For the proportion of participants whose tumours shrank (called the objective response rate), the figures reported were: 20% for the nivolumab plus ipilimumab group and 30% for the nivolumab plus relatlimab group in one part of the trial; and 17.4%, 3.1%, 3.2%, 9.5%, and 0.0% respectively across the five arms in another part of the trial. For how long those responses lasted (duration of response, measured in weeks), the reported median figures were 68 weeks and 99.4 weeks for two of the groups; for some groups this figure was listed as "not available," meaning the data was not reported for those arms. For the proportion of participants who had not experienced their disease getting worse at 24 weeks, the reported figures ranged from approximately 0.194 to 0.491 across the groups where data was provided; one group's figure was not reported. On the secondary measures, the reported data shows that across the five groups, between 19 and 45 participants experienced at least one adverse event (an unexpected medical occurrence during the study); between 9 and 28 participants experienced a serious adverse event (one serious enough to require hospitalisation or that was life-threatening); and between 2 and 10 participants in each group stopped taking their study medicine due to an 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 ↗ · Linked publication on PubMed ↗

  • NCT02432846 · results posted 22 August 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02432846) enrolled 88 people in total with kidney cancer — 58 received a combination of an investigational treatment called ilixadencel (also known as Intuvax) plus surgery (nephrectomy) and a standard medicine called sunitinib, while 30 received surgery and sunitinib alone. Participants were divided into two groups based on their level of disease risk: high-risk (25 people total) and intermediate-risk (63 people total). The trial's main goal was to measure how long participants lived overall, and what percentage were still alive at 18 months. The reported data shows that, looking at all participants combined, the median time from enrolment until death (called "overall survival") was reported as approximately 1,082 days for those who received ilixadencel plus sunitinib, compared with approximately 770 days for those who received sunitinib alone. (These figures come from one of two analysis methods used; the second method reported 1,265 days versus 1,024 days respectively.) For the 18-month survival percentage across all participants combined, the reported data shows 63% of the ilixadencel-plus-sunitinib group were alive at 18 months compared with 66% in the sunitinib-only group. Among secondary measures, the reported time until the disease progressed (stopped responding) was approximately 360 days in the ilixadencel-plus-sunitinib group and 337 days in the sunitinib-only group across all participants. The proportion of participants whose tumours showed a measurable reduction (called "objective response rate") was reported as 44.4% in the ilixadencel-plus-sunitinib group and 48.0% in the sunitinib-only group. It should be noted that for some subgroups, certain figures could not be calculated due to the nature of the data, and those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03141177 · results posted 26 April 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03141177) enrolled a total of 701 participants across three groups — Treatment A (323 people), Treatment B (50 people), and Treatment C (328 people). The trial was primarily measuring **progression-free survival (PFS)** — that is, how long participants went without their condition getting worse or without dying. It also tracked several secondary measures, including overall survival (how long participants lived), the proportion of participants whose tumours shrank or disappeared (called objective response rate), and the number of participants who experienced various types of adverse events (unwanted health events that occurred during the trial). The reported data shows that for the primary measure of progression-free survival, Treatment A was associated with a reported median of 16.59 months, compared to 8.31 months for Treatment C. (A "median" here means half the people in that group reached that time point before progression or death, and half did not.) Overall survival figures were not reported for either group at the time the results were submitted. For the objective response rate — the share of participants whose tumours showed a meaningful reduction — the reported figures were 55.7% for Treatment A, 44.0% for Treatment B, and 27.1% for Treatment C. Regarding adverse events, the reported data shows that 319 of 320 treated participants in Treatment A, all 50 in Treatment B, and 317 of 320 in Treatment C experienced at least one adverse event of any kind. Serious adverse events were reported in 160 participants (Treatment A), 28 (Treatment B), and 144 (Treatment C). Adverse events that led to stopping treatment were reported in 63, 15, and 54 participants respectively across the three groups. It is important to note that these numbers describe what was observed and recorded in this specific trial population — they do not indicate how any individual might respond. 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 ↗

  • NCT00126672 · results posted 25 April 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people, all of whom received a medicine called Rapamycin (also known as sirolimus). Of those 36, 28 completed the study and 8 did not finish. The trial was looking at how the drug affected certain tumours and other growths related to a genetic condition called Tuberous Sclerosis Complex (TSC) — a condition that can cause non-cancerous growths to form in many parts of the body. The reported data shows that the main thing being measured was the "objective response rate" — meaning the proportion of participants whose target growths either disappeared completely or shrank by at least 30% during treatment. According to the results reported on ClinicalTrials.gov, 44.4% of participants met this measure. For the secondary outcomes, the reported data shows that 1 out of 36 participants experienced a serious drop in white blood cells (called grade 3 or higher lymphopenia, which is when certain immune cells fall to a notably low level and is considered a significant side effect). Separately, the trial also tracked whether other TSC-related growths — such as brain tubers, certain brain tumours, facial skin growths, and kidney cysts — showed any changes; the reported data shows that 0 participants were recorded as having "no change" in these other lesions, though the way this outcome was reported on ClinicalTrials.gov is limited and fuller detail was not 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 ↗

  • NCT04033991 · results posted 18 February 2022

    According to the results reported on ClinicalTrials.gov, this study enrolled 684 people with advanced or metastatic kidney cancer (cancer that had spread beyond the kidney). It was an observational study — meaning researchers reviewed real-world medical records rather than assigning people to specific treatments — tracking patients who had received the drug sunitinib as their first treatment, axitinib as a second treatment, or both in sequence. In total, 622 participants received first-line sunitinib, and 121 received second-line axitinib; 59 of those had taken sunitinib first and then axitinib. The study was primarily measuring "progression-free survival" (PFS) — that is, how long patients went without their cancer visibly growing or spreading — and also tracked overall survival (OS), meaning how long patients lived from the start of each treatment. The reported data shows that for participants on first-line sunitinib, the median PFS (the point at which half the group had experienced disease progression) was reported as approximately 8.4 months overall. For those on second-line axitinib, the median PFS was reported as approximately 6.2 months. When participants were grouped by their individual risk profiles using two different scoring systems (called MSKCC and IMDC), the reported PFS figures varied considerably — ranging from around 14–16 months for those classified as lower risk down to roughly 2–6 months for those classified as higher risk, across both treatment lines. Some subgroup figures were not reported in the data. For overall survival, the reported data shows a median of approximately 18.3 months from the start of first-line sunitinib, and approximately 15.8 months from the start of second-line axitinib. Again, survival figures differed across risk subgroups, with some results listed as not available in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00003102 · results posted 5 January 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total across three groups, each receiving a different dose of radiation delivered via a radioactive antibody treatment. There were 3 participants in the lowest-dose group (50 cGy), 9 in the middle-dose group (75 cGy), and 3 in the highest-dose group (100 cGy). The trial was primarily measuring side effects — specifically how many participants experienced any unwanted health events, and how many experienced what are called "dose-limiting toxicities" (serious side effects severe enough to prevent further dose increases). The reported data shows that side effects of some kind were recorded for nearly all participants: 3 out of 3 in the lowest-dose group, 8 out of 9 in the middle-dose group, and all 3 in the highest-dose group. When it came to serious side effects that would limit the dose, the reported numbers were 0 out of 3 in the lowest-dose group, 1 out of 9 in the middle-dose group, and 3 out of 3 in the highest-dose group. For tumour response — a secondary measure — the reported data shows no complete or partial shrinkage of tumours in any group. Stable disease (meaning tumours neither clearly grew nor shrank) was reported in 2, 6, and 1 participants across the three groups respectively, while progressive disease (tumours growing) was reported in 1 participant in each group. The trial also tracked whether participants developed immune reactions to the antibody used; such reactions were detected in 1 participant in the lowest-dose group and 1 in the middle-dose group, with none reported in the highest-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 ↗

  • NCT03142334 · results posted 28 December 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03142334) enrolled 994 people with kidney cancer — 496 assigned to receive pembrolizumab (an immunotherapy medicine) and 498 assigned to receive a placebo (an inactive treatment). The trial was designed to measure how long participants stayed free of their cancer returning or spreading after surgery, and to track overall survival, as well as a number of other outcomes related to disease recurrence and side effects. The reported data shows that for the primary outcome — disease-free survival, meaning the length of time before the cancer came back, spread, or the person died — the recorded values are listed as "NA" (not available) for both the pembrolizumab group and the placebo group. This means no numerical result for this key measure was submitted in the structured data on ClinicalTrials.gov. Similarly, the reported data shows that all of the secondary outcomes — including overall survival, the number of participants who experienced side effects, the number who stopped treatment due to side effects, and the two disease recurrence measures — also have no figures submitted in the structured results. The data for these outcomes was not reported in the registry entry reviewed here. It is worth noting that while participant numbers and some trial milestones (such as how many completed or stopped treatment early) were recorded, the absence of outcome figures means no conclusions about what the numbers showed can be drawn from this registry entry 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 ↗

  • NCT02811861 · results posted 24 September 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,069 people across three groups — 357 in each group — who were assigned to one of three treatment combinations: lenvatinib plus everolimus, lenvatinib plus pembrolizumab, or sunitinib alone (which served as the comparison group). The trial was primarily measuring how long participants went without their disease getting worse or dying — a period called "progression-free survival." Several other outcomes, including overall survival, response rates, and side-effect data, were also planned but had not yet been reported at the time of this data submission, as the study's anticipated completion date is March 2026. The reported data shows that, on average, participants in the lenvatinib plus everolimus group went 14.7 months before their disease progressed or they died, while those in the lenvatinib plus pembrolizumab group went 23.9 months. In the sunitinib group, that figure was 9.2 months. These numbers represent the midpoint estimate (meaning half of participants in each group reached that point sooner, and half took longer). Because the secondary outcomes — including overall survival, response rates, and safety data — are not yet reported, those figures are not available to describe 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.

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

  • NCT00070070 · results posted 8 July 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT00070070) enrolled a total of 6 participants across four groups, called Cohorts 1 through 4. Cohort 1 had 1 participant, Cohorts 2 and 3 had no participants enrolled, and Cohort 4 had 5 participants. All 6 participants who started the trial completed it. The trial was measuring whether certain side effects called "dose-limiting toxicities" occurred — that is, serious enough reactions that would require a participant to stop treatment — and also tracking changes in the immune system, such as the development of specific antibodies and immune cell responses, following the study treatment. The reported data shows that across all four cohorts, no participants experienced a dose-limiting toxicity. For the immune response measurements, the reported data shows that in Cohort 4, 4 out of 5 participants developed NY-ESO-1 antibodies (proteins the immune system can produce) after treatment, while 1 participant in Cohort 1 also developed these antibodies. Regarding immune cell (T-cell) responses, all 5 participants in Cohort 4 and 1 participant in Cohort 1 showed CD4+ T-cell activity, while CD8+ T-cell responses were recorded in 1 participant in Cohort 4 only. A skin reaction test (called a delayed-type hypersensitivity test) was also measured at different time points; the reported data shows that across the timepoints, between 2 and 3 participants in Cohort 4, and 1 participant in Cohort 1, showed a measurable skin reaction. No data was reported for Cohorts 2 or 3, as no participants were enrolled in those groups. It is worth noting that this was a very small trial with only 6 participants in total, and the data as reported reflects only what was observed and 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 ↗

  • NCT03494816 · results posted 30 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03494816) enrolled 24 participants in a single group — meaning everyone received the same treatment with no comparison group. The trial was measuring whether a treatment could shrink a blood-clot-like tumour growth (called a venous tumour thrombus) that had extended from a kidney tumour into a large vein. Specifically, it tracked whether the level of this growth — rated on a scale called the Mayo Classification, where higher levels mean the growth has extended further into the body — was lower after 9 weeks of treatment compared to the start. Of the 24 people who started, 18 completed the trial and 6 did not. The reported data shows that, among the evaluable patients, 6 out of 15 were classed as "responders" — meaning their Mayo Classification level was lower at 9 weeks than at the start. For the secondary measurements: among those who went on to surgery, 6 out of 11 had a change in the surgical approach used; the average reduction in the physical height of the tumour growth was reported as approximately 21.5%. Using a standard tumour measurement tool called RECIST (which looks at changes in tumour size on scans), 3 patients showed a partial response (tumour shrank by 30% or more), 13 had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), and 2 had progressive disease (tumour grew). No complete disappearance of tumours was recorded. Regarding post-surgical complications recorded within 30 days, the reported data shows small numbers across different severity grades, with 1 patient each in the lower-severity categories (Grades I and IVa) and 3 in Grade II; no data was reported for the number of deaths in this window beyond what was captured in these 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 ↗ · Linked publication on PubMed ↗

  • NCT00520533 · results posted 16 June 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom received a combination of two treatments: cG250 (an antibody) and sunitinib (a cancer medicine). Four participants completed the trial and four did not complete it. The trial was studying kidney cancer and was measuring a range of things: how participants responded in terms of side effects and tolerability, whether tumours changed in size, how the body processed a special radioactive form of the antibody (called 124I-cG250), and whether tumours could be detected using different types of scans. The reported data shows that, out of 8 participants, 6 experienced adverse events (unwanted effects that were recorded and monitored), 3 experienced serious adverse events (more significant unwanted effects), 2 experienced dose-limiting toxicities (side effects serious enough to affect the dose that could be given), and 1 had an adverse event that led to them stopping the treatment. For tumour size changes (assessed using a standard measuring tool called RECIST), the reported data shows 0 participants had a complete disappearance of tumours, 1 had a meaningful reduction in tumour size (partial response), 3 had stable disease (no significant change either way), and 0 had tumour growth recorded under this measure. For tumour activity measured by a different type of scan (FDG-PET, which looks at how active tumour cells are), the reported data shows 1 participant had a complete metabolic response, 0 had a partial metabolic response, and 3 had stable metabolic disease. Regarding how quickly the radioactive antibody cleared from the body, the reported data shows an average biological half-life (the time for half the substance to be cleared biologically) of approximately 121 days after the first infusion and 149 days after the fifth infusion, and an effective half-life (accounting for both biological clearance and radioactive decay) of approximately 54 hours after the first infusion and 59 hours after the fifth infusion. The reported data also shows that 6 participants had detectable uptake of the radioactive antibody in their tumours after the first infusion, and 4 did after the fifth infusion. 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 ↗

  • NCT01147536 · results posted 3 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01147536) involved 12 participants, all of whom received at least one dose of the treatment being studied — a vaccine called HSPPC-96. The trial was a single-group study, meaning everyone received the same treatment with no comparison group. Nine of the 12 participants completed the study, while three did not finish. The main thing the trial set out to measure was whether participants showed a positive immune response (that is, whether their immune system reacted to the vaccine), using a laboratory test called an ELISPOT assay — a method for detecting immune activity in blood samples. The reported data shows that, for the primary outcome measure — the immune response test — no results are available. According to the information submitted to ClinicalTrials.gov, the ELISPOT assay was not developed for use in this study, and therefore no immunological data were collected or reported. No secondary outcome measure data were included in the submitted results either. In summary, while 12 people took part and the study did proceed to the point of dosing all participants, the key measurement the trial was designed to capture was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02118337 · results posted 1 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02118337) enrolled 97 participants in total across nine treatment groups. The groups tested different doses of a drug called MEDI0680 — given either alone or combined with another drug called durvalumab — and compared some of these to a separate group receiving an existing treatment called nivolumab. The trial had two phases: a dose-escalation phase (where researchers tested increasing doses to track unwanted medical events) and a dose-expansion phase (where researchers measured how many participants' tumours responded to treatment). The reported data shows that in the dose-escalation phase — which covered six groups totalling 30 participants — every participant in each group experienced at least one treatment-emergent adverse event (that is, a new or worsening medical problem that appeared after starting the study drug). Serious adverse events (those involving hospitalisation, life-threatening situations, or other significant outcomes) were reported in 11 of those 30 participants, spread unevenly across the groups. Smaller numbers of participants had abnormal blood or urine test results, abnormal vital signs (such as blood pressure or heart rate), or abnormal heart-trace (ECG) readings recorded as adverse events. In the dose-expansion phase, the reported objective response rate — meaning the proportion of participants whose tumours showed a confirmed meaningful reduction in size — was 0% for MEDI0680 alone (4 participants), 16.7% for MEDI0680 combined with durvalumab (42 participants), and 23.8% for nivolumab (21 participants). Looking at the broader picture of how tumours behaved, the reported data shows that confirmed partial responses (tumours shrinking meaningfully) were recorded for 0, 5, and 5 participants in those three groups respectively, while disease progression was recorded for 1, 17, and 6 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 ↗ · Linked publication on PubMed ↗

  • NCT03165721 · results posted 10 May 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03165721) enrolled a total of nine participants aged 12 and over across three groups: seven with a type of stomach/intestinal tumour called wild-type GIST, one with a rare tumour of the adrenal gland or nearby nerves (PHEO/PGL with SDH-deficiency), and one with a kidney cancer linked to a condition called HLRCC. The trial was testing a treatment called SGI-11, and the main thing it set out to measure was whether any participants' tumours shrank significantly — either disappearing completely or reducing in size by at least 30% — according to a standard set of tumour-measurement rules known as RECIST. The reported data shows that for the primary outcome, the number of participants whose tumours shrank by the required amount was zero across all three groups — no complete responses and no partial responses were recorded in any group. For distress levels (measured using a 0–10 scale where higher scores mean more distress), the reported data shows baseline scores of 6.4, 7, and 2 for the three groups respectively, with later scores suggesting some variation over time, though the data was not reported for all time points in all groups. For a quality-of-life measure (scored so that 50 represents an average for the general population), baseline scores ranged from around 45.9 to 57.7 across groups, with some variation at later time points. The reported data also shows that among the wild-type GIST group, roughly 85.7% had not shown disease progression at 6 months and approximately 53.6% at 12 months; for the other two groups, these figures were reported as 0%, though this likely reflects the very small number of participants rather than a broader finding. Overall survival 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 ↗

  • NCT01164228 · results posted 13 April 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 87 people in total — 47 in a group receiving a combination of two medicines (sunitinib plus gemcitabine) and 40 in a group receiving sunitinib on its own. The trial was measuring how often tumours shrank or disappeared, how long participants went without their cancer getting worse, and how long participants lived overall. The reported data shows that when it came to tumour response — meaning the tumour either disappeared completely or shrank by at least 30% — 18 out of every 100 participants (a proportion of 0.18) in the combination group had this outcome, compared with 11 out of every 100 (a proportion of 0.11) in the sunitinib-only group. For progression-free survival — the length of time before the cancer grew or a participant died, whichever came first — the reported figures were 4.5 months for the combination group and 3.6 months for the sunitinib-only group. For overall survival — the time from the start of the trial until death or last known to be alive — the reported figures were 9.4 months for the combination group and 7.8 months for the sunitinib-only 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 ↗

  • NCT03173560 · results posted 5 March 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03173560) enrolled 343 people in total — 172 in one group and 171 in another. Both groups took a combination of two medicines, lenvatinib and everolimus, but at different doses: one group received lenvatinib 14 mg plus everolimus 5 mg, and the other received lenvatinib 18 mg plus everolimus 5 mg. The trial was measuring two main things: how many participants showed a meaningful shrinkage in their tumours by Week 24, and how many experienced moderate-to-severe unwanted side effects within that same 24-week period. The reported data shows that, for tumour response at Week 24, 32.1% of participants in the lower-dose group and 34.8% in the higher-dose group had their tumours shrink to a degree that met the trial's response criteria. When looking at the full treatment period (not just Week 24), those figures were 34.6% and 40.6% respectively. For the side-effect measure, 82.8% of participants in the lower-dose group and 79.6% in the higher-dose group experienced moderate-to-severe unwanted effects within 24 weeks. The reported data also shows that 173 out of 173 participants in the lower-dose group and 167 out of 168 in the higher-dose group experienced at least one unwanted effect during the study, while serious unwanted effects were recorded in 92 and 87 participants respectively. Regarding stopping treatment early because of those effects, 17.4% in the lower-dose group and 25.1% in the higher-dose group discontinued for that reason. On a secondary measure, the reported data shows the median time before the disease progressed or death occurred — called progression-free survival — was 11.1 months in the lower-dose group and 14.7 months in the higher-dose group, though the trial notes this secondary data was only collected and analysed up to the primary analysis point. 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 ↗

  • NCT01673386 · results posted 27 October 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 58 people in total — 27 were assigned to receive tivozanib first followed by sunitinib, and 31 received sunitinib first followed by tivozanib. The trial was designed to compare the two medications by asking participants which they preferred, and to track certain health events that occurred while taking each drug. However, the trial was stopped early because not enough people enrolled, meaning the main question the study set out to answer — which treatment participants preferred — could not be assessed, and no data was collected for that primary outcome. The reported data shows that some information was gathered on health events (called adverse events) experienced by participants during the study. Across both treatment periods combined, 35 out of 58 participants reported at least one adverse event while taking tivozanib, compared with 40 out of 58 while taking sunitinib. More specifically, 33 participants reported a non-serious adverse event on tivozanib and 38 on sunitinib. Serious adverse events (unexpected health problems significant enough to require hospitalisation or similar) were reported in 6 participants on tivozanib and 7 on sunitinib. The reported data also includes smaller counts for other categories of events, but several other planned outcome measures — including dose reductions, dose interruptions, and blood or chemistry test abnormalities — were not collected due to the early termination of the trial. Because the study closed before reaching its target number of participants, the results are incomplete and limited in what they can tell us. 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 ↗

  • NCT00749892 · results posted 10 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people with urothelial cancer (a type of cancer affecting the bladder and urinary tract). All participants received a drug called erlotinib before undergoing surgery to remove their bladder (a procedure called cystectomy). Of the 34 who started, 31 completed the study and 3 did not. The trial's main goal was to measure how many participants showed no remaining cancer in the tissue removed during surgery — a result doctors call "pT0," meaning no detectable disease was found in the surgical specimen. The reported data shows that out of the participants measured, 8 were classified as responders — meaning their removed tissue showed no remaining cancer at the time of surgery. A separate figure of 18 participants was also listed in the data for the same outcome measure, though it is not clearly explained in the submitted results what this second number specifically represents, so it would not be appropriate to interpret it further here. Regarding the secondary outcome — estimated four-year disease-free survival (meaning how many people showed no return of cancer over four years) — no data was reported for this measure on 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 ↗

  • NCT00502307 · results posted 1 September 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called tivozanib (also known as AV-951) in people with a specific type of cancer. The trial had two main stages. In the first stage, 272 people received tivozanib in an open-label period (meaning everyone knew what treatment they were getting) for 16 weeks. Of those, 196 completed this stage. In the second stage, 118 people were randomly assigned — in a blinded fashion (neither participants nor doctors knew who received which treatment) — to either continue tivozanib (61 people) or receive a placebo, which is an inactive dummy treatment (57 people), for a further 12 weeks. The reported data shows several things were measured. For the first stage, when looking at how many people's tumours shrank or disappeared (called "objective response"), investigators reported 1 complete response (full disappearance of target tumour areas) and 66 partial responses (meaningful shrinkage), while an independent panel of reviewers reported 0 complete responses and 49 partial responses, out of the participants assessed. For the second, blinded stage, the reported data shows how many people remained free from their cancer progressing (getting worse) at the 12-week mark: in the tivozanib group, 35 of 61 participants (by investigator assessment) or 30 of 61 (by independent review) were reported as progression-free; in the placebo group, 16 of 57 (by investigator assessment) or 12 of 57 (by independent review) were reported as progression-free. The trial also measured the time it took the drug to reach its highest level in the blood in a subset of participants, which was reported as approximately 7.1 hours on average. Some additional measurements related to how long people went without their disease worsening were also reported, though the full detail of those figures was not completely described 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 ↗

  • NCT02348008 · results posted 31 July 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02348008) enrolled a total of 61 people with advanced kidney cancer (specifically metastatic clear cell renal carcinoma). Participants were split across three groups: a small early-phase dose-finding group (3 people), a second dose-finding group (10 people), and a larger main treatment group (48 people). The trial was measuring two things: first, what the highest tested dose of one of the medicines (bevacizumab) could be when combined with a fixed dose of the other medicine (pembrolizumab); and second, how many participants' tumours shrank or disappeared during treatment. The reported data shows that in the early dose-finding phase, the highest tested dose of bevacizumab reached was 15 mg/kg. When looking at tumour shrinkage (called the "overall response rate" — meaning the proportion of people whose tumours completely disappeared or shrank by at least 30%), the reported figures were 41.7% in the early-phase group and 60.9% in the main Phase II group. For how long participants went without their cancer getting worse (called "progression-free survival"), the reported median — meaning the midpoint figure for the group — was 9.9 months in the early-phase group and 20.7 months in the main group. The reported median overall survival (how long participants lived from the start of the trial) was 17.9 months for the early-phase group; for the main Phase II group, this figure was not reported in the data. A separate measure called the "clinical benefit rate" — which counted people whose disease either shrank or stayed stable — was reported as 91.67% in the early-phase group and 100% in the main group. The reported data also recorded serious side effects (graded 3 or 4 out of 4 in severity, meaning significant or severe) across all participants, with 12 categories of events listed and individual counts ranging from 1 to 15 occurrences per event type; however, the specific names of each side effect category were not included in the structured data submitted, so a fuller breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01307267 · results posted 17 March 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01307267) enrolled a total of 203 participants across 23 different dose groups. The trial was testing a drug called PF-05082566 (also known as utomilumab) in people with certain blood cancers. It was an early-phase "dose-finding" study, meaning researchers were testing many different dose levels to understand how the drug behaved in the body. Part A tested PF-05082566 on its own across 12 dose levels, while Part B tested it in combination with another drug called rituximab across 11 dose levels. The main thing the trial was measuring was how many participants experienced what are called "dose-limiting toxicities" — meaning serious unwanted effects serious enough that they would limit how much of the drug could be given. The reported data shows that in Part A (PF-05082566 alone), only 1 out of the 122 participants across all dose levels experienced a dose-limiting toxicity, and that was in the 0.24 mg/kg dose group which had 42 participants. In Part B (PF-05082566 combined with rituximab), zero out of 64 participants across all dose levels experienced a dose-limiting toxicity. Regarding other unwanted medical events that occurred during treatment, the reported data shows these were recorded across most dose groups in both parts of the trial — for example, in Part A, 39 of the 42 participants in the 0.24 mg/kg group and 26 of the 31 participants in the 1.2 mg/kg group had at least one such event recorded. The numbers of participants who completed the full study period were low across most groups, with the majority not completing 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 ↗

  • NCT02178722 · results posted 19 December 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 444 people across two phases. The first phase (62 participants) tested different doses of a drug called epacadostat, given twice daily, to look at how participants responded to the treatment and what unwanted effects they experienced. The second phase (382 participants) tested a combination of epacadostat (100 mg twice daily) and another drug called pembrolizumab across several different cancer types, with the main goal of measuring how many participants' tumours shrank or disappeared. The reported data shows that in Phase 1, between 94% and 100% of participants across the dose groups experienced at least one treatment-emergent adverse event (an unwanted sign or symptom that appeared or worsened after starting the study drug). Serious adverse events — meaning events that were life-threatening, caused hospitalisation, or were otherwise considered medically significant — were reported in 40% of participants in the 50 mg group, 50% in the 100 mg group, and 45% in the 300 mg group, with none reported in the small 25 mg group (which had only 4 participants). For Phase 2, the reported data shows the proportion of participants whose tumours shrank enough to count as a response varied across cancer types, with figures ranging from approximately 8% to 61% depending on the cancer group. For time-related measures — how long responses lasted, how long before the disease progressed, and overall survival — the reported data shows results that also varied considerably by cancer type, with some figures not reported for certain groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01545817 · results posted 9 October 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people who first received a medicine called pazopanib, and 38 of those people then went on to receive a second medicine called everolimus. The trial was looking at how long patients went without their disease getting worse (called "progression-free survival"), as well as how long patients lived overall, and whether tumours shrank during treatment. The reported data shows that for patients on the second medicine (everolimus), the midpoint time before the disease progressed or death occurred was 5.1 months. When looking at survival probability at specific time points during everolimus treatment, the reported figures show that approximately 73.7% of patients had not experienced progression at 3 months, and approximately 35.5% had not at 6 months. For tumour response during everolimus treatment, 0% of patients had a complete disappearance of tumours, while 7.9% had tumours shrink by at least 30%. During the earlier pazopanib treatment period, the reported data shows 6.8% had complete disappearance and 39.2% had tumours shrink by at least 30%. The reported data also shows that from the time patients started everolimus, the midpoint survival time was 15.6 months. For patients who received both medicines in sequence, the midpoint survival time from the very start of treatment (pazopanib) was reported as 35.7 months. It is worth noting that in both treatment periods, 0 participants were recorded as having "completed" the study, meaning all participants either progressed, withdrew, or were otherwise recorded as not completing — the data does not provide a fuller breakdown of these reasons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01358721 · results posted 26 July 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01358721) involved 91 people with advanced kidney cancer (specifically a type called metastatic clear-cell renal cell carcinoma). Participants were split into four groups and given different doses of a drug called nivolumab — either 0.3 mg/kg, 2 mg/kg, or 10 mg/kg. Three of the groups had received prior treatment, while one group had not. The trial was primarily measuring how nivolumab affected the immune system — specifically, certain immune-signalling proteins in the blood (called CXCL9 and CXCL10) and the number of immune cells (called CD4 and CD8 T cells) found inside tumours. As a secondary measure, the trial also tracked whether tumours shrank or disappeared. The reported data shows that for the two blood proteins measured, average levels of CXCL9 ranged from around 1,907 to 2,860 pg/mL (picograms per millilitre, a very small unit of measurement) at the start of the study, and rose to between approximately 3,859 and 5,447 pg/mL at a later time point across the four groups. Similarly, average CXCL10 levels started between around 422 and 526 pg/mL and rose to between approximately 701 and 813 pg/mL across the groups. For immune cells found in tumours, the reported data shows mean CD4 T cell counts ranged from about 10 to 53 at baseline and rose to between 28 and 107 at a follow-up point; CD8 T cell counts ranged from about 8 to 14 at baseline and rose to between 15 and 23 at follow-up. The data for the "activated and memory T cells" primary measure was not reported. Regarding tumour response, the reported numbers show that complete responses (tumour disappearing entirely) were recorded in 0, 0, 0, and 2 participants across the four groups respectively, while partial responses (tumour shrinking by at least 30%) were seen in 2, 4, 5, and 1 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 ↗ · Linked publication on PubMed ↗

  • NCT01391130 · results posted 23 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in total — 73 in the group receiving a combination of LY2510924 and sunitinib, and 37 receiving sunitinib alone. The trial was mainly measuring how long participants went without their cancer getting worse (called "progression-free survival"), and also tracked a number of other things including how many people's tumours shrank, how long any shrinkage lasted, and how long participants lived overall. The reported data shows that for the main measure — time without the cancer getting worse — participants in the combination group had a reported figure of around 8 months on average, compared with around 12 months in the sunitinib-alone group. For tumour shrinkage (either complete disappearance or a meaningful reduction in size), about 31.9% of people in the combination group and 38.9% in the sunitinib-alone group met those criteria. How long that shrinkage lasted was reported as approximately 11 months in the combination group and around 12 months in the sunitinib-alone group. Overall survival — how long participants lived from the start of the trial — was reported as approximately 24 months in the combination group and approximately 24 months in the sunitinib-alone group. For the duration of a complete response (tumour fully disappearing) in the sunitinib-alone group, a figure of 10 months was reported; the equivalent figure for the combination group was not reported in the 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 ↗

  • NCT01282463 · results posted 2 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 148 people in total across three groups: 49 received docetaxel alone, 49 received docetaxel combined with a drug called ramucirumab, and 50 received docetaxel combined with a drug called icrucumab. The trial was primarily measuring how long participants went without their cancer growing or spreading — a period researchers call "progression-free survival." It also looked at secondary measures including how many participants saw their tumours shrink or disappear (called the "objective response rate"), how long those responses lasted, and what side effects (called adverse events) were recorded. The reported data shows that, for the main measure — the time until the cancer grew or a participant died — the docetaxel-alone group had a median of 2.8 months, the docetaxel-plus-ramucirumab group had a median of 5.4 months, and the docetaxel-plus-icrucumab group had a median of 1.6 months. (A "median" is simply the middle value — half the participants had a shorter time and half had a longer time.) For the secondary measure of how many participants saw a meaningful tumour shrinkage or disappearance, the reported figures were 8.9% in the docetaxel-alone group, 23.9% in the docetaxel-plus-ramucirumab group, and 12.2% in the docetaxel-plus-icrucumab group. Among those who did respond, how long that response lasted was reported as 4.6 months in both the docetaxel-alone and docetaxel-plus-ramucirumab groups; this figure was not reported for the icrucumab group. Adverse events (unwanted side effects of any kind) were recorded in all participants who received at least one dose of their assigned treatment across all three 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 ↗

  • NCT00727532 · results posted 3 May 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 9 people, all of whom received a drug called sorafenib. Seven participants completed the study, and two did not. The trial was looking at whether sorafenib, given before surgery, caused measurable changes in kidney tumours in people with locally advanced or metastatic (spread beyond the kidney) kidney cancer. Researchers used MRI scans to track two main things: a measure called the "apparent diffusion coefficient" (ADC) — which reflects how freely water moves within a tumour and can indicate tissue breakdown — and the physical size of the tumour. The reported data shows that, on average, the ADC value changed by approximately −7.57% between the start of treatment and week 5. A negative change in this measure means water movement in the tumour decreased slightly on average, rather than increasing as researchers had anticipated. The reported data also shows that tumour size, measured by standard imaging criteria, changed by an average of −5.34% (a small average reduction in size) from the start of treatment to roughly 29–34 days after sorafenib treatment was completed, just before surgery. In an additional analysis reported after the main study, the reported data shows that the amount of dead (necrotic) tissue visible on MRI scans increased by an average of 20.13% from the start of treatment to the time of surgery. It is important to note that this was a very small study with only 9 participants, so these numbers reflect a narrow group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00945009 · results posted 5 March 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT00945009) enrolled 249 children across three groups: 201 with bilateral Wilms tumours (cancer affecting both kidneys), 39 with a unilateral high-risk tumour in children considered at higher risk of developing cancer in the other kidney, and 9 with a condition called DHPLN (abnormal kidney tissue that can develop into cancer). The trial was measuring things like how well chemotherapy given before surgery could preserve kidneys, and how long children went without their cancer returning or spreading. The reported data shows the following results. For children with bilateral Wilms tumours, the probability of going without a relapse, a new cancer, or death was reported as 0.82 (meaning roughly 82 out of every 100 children in this group remained event-free during the follow-up period). In that same group, 39% of patients kept at least one kidney rather than having both fully removed, and 85% reached their definitive (final planned) surgery by week 12 of treatment. For children in the high-risk unilateral group, 57% were reported to have had a partial kidney removal (where only part of the kidney is taken out) rather than full removal. For the small DHPLN group, 7 out of 9 participants were reported to have kept at least one kidney without complete removal. The reported data shows these figures as measured at the time the results were submitted. It is worth noting that the DHPLN group was very small (only 9 children), so the numbers from that group are based on very few individuals. 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 ↗

  • NCT01136733 · results posted 27 February 2019

    According to the results reported on ClinicalTrials.gov, this trial ran in two stages. The first stage (Phase 1b) involved 20 people across three groups who received different dose combinations of two medicines — lenvatinib and everolimus — to find the highest dose that could be given without causing too many serious side effects. The second stage (Phase 2) enrolled 153 people, split across three groups: 51 received the combination of lenvatinib 18 mg plus everolimus 5 mg, 52 received lenvatinib 24 mg on its own, and 50 received everolimus 10 mg on its own. The trial was measuring things like how long participants went without their disease getting worse, how long they survived overall, and how many showed a reduction in their tumour. The reported data shows that in Phase 1b, the dose identified as the highest manageable level — which then became the dose used in Phase 2's combination group — was 18 mg of lenvatinib combined with 5 mg of everolimus. For Phase 2, the reported results show that the time participants went without their disease getting worse (called progression-free survival) was a median of 14.6 months in the combination group, 7.4 months in the lenvatinib-alone group, and 5.5 months in the everolimus-alone group. The reported median overall survival — meaning the midpoint for how long participants lived from the start of the study — was 25.5 months, 19.1 months, and 15.4 months for those three groups respectively. The reported data also shows that the proportion of participants whose tumours shrank (known as the objective response rate) was approximately 43% in the combination group, 27% in the lenvatinib-alone group, and 6% in the everolimus-alone group. When also counting participants whose disease held steady for at least seven weeks (called disease control rate), the reported figures were approximately 84%, 79%, and 68% across those same three 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 ↗

  • NCT02866695 · results posted 25 February 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who were solid organ transplant recipients (such as kidney or liver transplant patients) and had a skin condition called actinic keratosis — rough, scaly patches caused by sun damage that can sometimes develop into skin cancer. All 20 participants received a gel called ingenol mebutate (0.015% strength) applied to the face. The trial was measuring two main things: what side effects or reactions occurred, and whether the number of actinic keratosis patches on participants' faces changed over the course of treatment. Eighteen of the 20 people completed the trial, and two did not finish. The reported data shows that 12 out of 20 participants experienced at least one adverse event (an unwanted medical event recorded during the trial), with smaller numbers experiencing various specific types of events — for example, 11 participants had one category of event, 6 had another, down to single participants for some categories. The full breakdown of what each of these categories of events were was not clearly labelled in the submitted data. For the secondary outcomes, the reported data shows that 12 out of 20 participants had a reduction in the number of actinic keratosis patches on their face, while 8 out of 20 did not. The trial also measured local skin reactions (redness, blistering, crusting, and swelling) using a score from 0 to 16, where a higher number means a worse reaction. The reported data shows the average score was 1.2 at the start of treatment and rose to 11.7 at its peak, before assessments continued at later time points — though those later figures were not separately detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03029780 · results posted 19 December 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT03029780) enrolled 104 people in total — 52 in each of two groups. One group received a "fixed ratio combination" of two therapies given together at the same time (Arm A), while the other received a "sequential combination" where the therapies were given one after the other (Arm B). The trial was primarily measuring how many participants experienced a particular type of serious reaction — known as an anaphylactic (severe allergic-type) reaction — within two days of receiving any dose during the combination treatment period. Only 1 person in each group completed the full study, with 51 in each group not completing it. The reported data shows that for the primary measure — the broader definition of anaphylactic-type reactions — 11.5% of participants in both Arm A and Arm B experienced at least one such event. When a stricter, narrower definition of that same type of reaction was used (a secondary measure), the figure was 0% in both groups, meaning none were recorded under that tighter definition. For other secondary measures, the reported data shows that around 48% of Arm A participants and 42% of Arm B participants experienced a serious adverse event (grade 3 or higher, meaning significant in severity) considered related to the study treatment. When looking at all serious adverse events regardless of cause, those figures rose to approximately 73% in Arm A and 65% in Arm B. In terms of tumour response, 50% of Arm A participants and approximately 33% of Arm B participants were reported to have had their tumour shrink meaningfully (either completely or partially). The reported median time before the disease progressed or death occurred was approximately 12 months for Arm A and approximately 7.7 months for Arm B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02231749 · results posted 16 October 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,096 adults with previously untreated advanced kidney cancer (metastatic renal cell carcinoma). Participants were randomly assigned to receive either a combination of two immunotherapy medicines — nivolumab and ipilimumab (550 people) — or a single targeted therapy medicine called sunitinib (546 people). The trial was primarily measuring three things in the higher-risk participants: the proportion whose tumours shrank or disappeared (called the objective response rate, or ORR), how long participants lived overall (overall survival, or OS), and how long they went before their disease worsened (progression-free survival, or PFS). The reported data shows the following numbers for the higher-risk group. For tumour shrinkage or disappearance, 41.6% of participants in the nivolumab + ipilimumab group and 26.5% in the sunitinib group met that measure. For how long participants lived overall, the nivolumab + ipilimumab group's median figure was reported as "not reached" (meaning more than half the group was still alive at the time the data was collected, so a midpoint could not be calculated), while the sunitinib group's median overall survival was reported as approximately 26 months. For how long before disease worsening, the reported median was about 11.6 months in the nivolumab + ipilimumab group and about 8.4 months in the sunitinib group. For secondary outcomes looking at all risk levels combined, the reported median overall survival figures were approximately 52.7 months and 37.8 months respectively, and the reported progression-free survival figures were approximately 12.4 months and 12.3 months respectively. The reported tumour shrinkage or disappearance rate across all risk groups was 39.5% versus 33.0%. 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 ↗

  • NCT02420821 · results posted 3 October 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 915 people in total — 461 received sunitinib and 454 received a combination of atezolizumab and bevacizumab. The trial was measuring how these two treatment approaches compared in people with kidney cancer, looking at how long it took for the disease to progress (get worse), how long people lived overall, and what proportion of participants experienced disease progression or death. Some measurements were taken across all participants (called the "ITT population") and some in a smaller subgroup whose tumours had a specific biological marker called PD-L1. The reported data shows the following results. In the PD-L1-selected subgroup, the median time until disease progression or death was reported as 7.5 months for the sunitinib group and 11.2 months for the atezolizumab + bevacizumab group. The percentage of participants in this subgroup whose disease progressed or who died was reported as 69.6% for sunitinib and 58.4% for the combination group. Across all participants (the ITT population), the median time that participants were alive from the start of the trial was reported as 35.3 months for sunitinib and 36.1 months for the combination, with around 55% of participants in each group recorded as having died by the time of analysis. In the PD-L1-selected subgroup, the reported median overall survival figures were 31.6 months for sunitinib and 38.7 months for the combination group, with 56.5% and 53.9% of participants respectively recorded as having died. 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 ↗

  • NCT00090870 · results posted 12 July 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study — none dropped out. All participants had metastatic renal cell carcinoma (a type of kidney cancer that has spread to other parts of the body) and received a combination of three treatments: PEG-Intron (a type of immune-boosting medicine), GM-CSF (another immune-system medicine, listed in the trial data as BM-CSF), and thalidomide. The trial was set up to measure how often the cancer responded to this combination, how long any response lasted, how long participants went without their cancer getting worse, and what unwanted side effects occurred. The reported data shows that, unfortunately, no numerical results were submitted for any of the outcome measures — not for the response rate (the primary goal of the trial), nor for any of the four secondary measures, including duration of response, progression-free survival, or the frequency of adverse events (unwanted side effects). Because no measurement data was provided in the ClinicalTrials.gov submission, it is not possible to describe what the numbers showed for any of these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01727089 · results posted 26 June 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01727089) enrolled 59 people with cancer across two groups. Twenty-nine participants received bevacizumab alone (Arm I), and 30 received bevacizumab combined with an additional experimental drug called TRC105 (an anti-endoglin monoclonal antibody) (Arm II). The trial was primarily measuring how many participants went 12 and 24 weeks without their cancer getting worse — a measure known as "progression-free survival," which simply means the cancer had not grown or spread by a set point in time. The reported data shows that at 12 weeks, 66% of participants in the bevacizumab-only group and 58% in the combination group had not experienced cancer progression. At 24 weeks, those figures were 52% in the bevacizumab-only group and 27% in the combination group. For overall tumour response (meaning the tumour either disappeared completely or shrank by at least 30%), the reported data shows that 1 participant in each group met that measure. Regarding serious side effects (graded as severe or worse, meaning Grade 3 and above), the reported data shows that 3 participants in the bevacizumab-only group and 3 in the combination group experienced Grade 3 events of one reported type, with further counts recorded across additional categories — the full breakdown was reported across multiple side-effect categories rather than as a single total 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 ↗

  • NCT02075658 · results posted 14 February 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in each group. One group had their surgery using a conventional gas-inflation system (used to create space inside the abdomen during keyhole surgery), while the other group used a device called the AirSeal® System. The trial was measuring how steady the pressure inside the abdomen stayed during surgery, and whether there were any differences in how well the heart pumped blood between the two groups. The reported data shows that, for the main measurement — the variation (ups and downs) in abdominal pressure during surgery — the conventional group had a variance of 5.5 mmHg (millimetres of mercury, a standard unit for measuring pressure), while the AirSeal® group had a variance of 1.3 mmHg. In plain terms, the pressure in the AirSeal® group appeared to fluctuate less during the procedure, based on the numbers submitted. Of the 30 people who started in each group, 28 completed the study and 2 did not complete it in each group. The reported data shows that for the secondary measurement — heart pumping output (the amount of blood the heart moves per minute) — no numerical results were reported for either group; the data was listed as not 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 ↗

  • NCT01984242 · results posted 21 December 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01984242) enrolled 305 people with kidney cancer across three treatment groups: 101 people received a combination of atezolizumab and bevacizumab, 103 received atezolizumab alone, and 101 received sunitinib (a standard comparison treatment). The trial was primarily measuring how long people went without their cancer growing or spreading — called progression-free survival — and what proportion of people experienced their cancer growing or spreading, or died, during the study period. These were measured across all participants as a whole, and also within a subgroup of participants whose tumours showed certain immune cell activity. The reported data shows that, across all participants, the estimated median time before cancer grew or a death occurred was 11.7 months in the atezolizumab-plus-bevacizumab group, 6.1 months in the atezolizumab-alone group, and 8.4 months in the sunitinib group. The proportion of people who experienced cancer progression or death was reported as 66.3%, 59.2%, and 58.4% in those same three groups respectively. In the subgroup with higher immune cell activity in their tumours, the reported median times were 14.7 months, 5.5 months, and 7.8 months, with 58.0%, 59.3%, and 68.3% experiencing progression or death. A further subgroup defined by a particular immune gene pattern showed median times of 17.5 months, 5.7 months, and 7.1 months, with 55.6%, 61.4%, and 73.8% experiencing progression or death. It is worth noting that zero participants were recorded as having formally "completed" the study in the data as submitted — all participants were listed under "not completed" — though the data does not explain the specific reasons for this in the structured results. The reported data reflects what was measured and recorded during the trial period for 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 ↗

  • NCT01023958 · results posted 22 November 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom received a drug called volasertib (also known as BI 6727). The trial was measuring how tumours responded to this treatment in people with solid cancers, using a standard set of rules called RECIST criteria to assess whether tumours shrank, stayed the same, or grew. The reported data shows that none of the 50 participants were recorded as having "completed" the trial in the formal sense — all 50 were listed under "not completed," though this does not necessarily mean they dropped out early, as this categorisation can reflect how the trial was structured. The reported data shows that 14% of participants had their tumour shrink to a degree that counted as either a complete response (tumour disappearing entirely) or a partial response (tumour shrinking by a meaningful amount) — this was the trial's main question. Among those who did have such a response, the reported duration of that response was around 41 weeks. Looking at a broader measure, 40% of participants were reported to have had their disease "controlled" — meaning their tumour either shrank or remained stable rather than growing — and for those people, that period of disease control lasted a reported average of around 27 weeks. The reported data also shows figures for how long, on average, participants went before their disease progressed or they passed away — recorded as approximately 6.1 weeks — and the overall survival figure, meaning the time from first treatment until death, was reported as a median of around 8.5 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01931462 · results posted 20 November 2017

    According to the results reported on ClinicalTrials.gov, this trial looked at a surgical device called the Certus 140™, which uses microwave energy to reduce bleeding during a type of kidney surgery called a partial nephrectomy (where only part of the kidney is removed). Only 2 people were enrolled in the study — one completed it and one did not. The main thing being measured was how kidney function changed before and after surgery, using a test called the estimated Glomerular Filtration Rate (eGFR) — a score that gives an indication of how well the kidneys are filtering the blood. The reported data shows that for the primary measure, the eGFR scores recorded were 66 and 86 (these appear to be the before and after scores), with a reported change of 20 units between them. For the secondary measures, the reported data shows a blood loss of 300 mL, an operative (surgery) time of 129 minutes, and a clamp time of 0 minutes — meaning no clamping of blood vessels was recorded. Two creatinine readings (another way of checking kidney function through a blood test) were reported as 1.13 mg/dL and 0.90 mg/dL. No data was reported for the measure of change in functional kidney volume as seen on MRI scans. It is important to note that with only 2 participants, this was an extremely small study, and the reported data reflects only those individuals' 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 ↗

  • NCT01865747 · results posted 18 July 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01865747) compared two medicines — cabozantinib and everolimus — in people with a type of kidney cancer. A total of 658 people took part overall (330 received cabozantinib and 328 received everolimus), with a smaller sub-group of 375 people included in the main (primary) analysis. The trial was measuring how long people went without their cancer growing or spreading (called progression-free survival), how long people lived overall (overall survival), and how many people's tumours shrank or disappeared (objective response rate). The reported data shows the following numbers. For the main measure — time without cancer progression — the reported median (meaning the midpoint figure for the group) was 7.4 months for those taking cabozantinib and 3.8 months for those taking everolimus. For overall survival, the reported median was 21.4 months in the cabozantinib group and 16.5 months in the everolimus group. For tumour shrinkage or disappearance, the reported data shows that 17% of participants in the cabozantinib group and 3% in the everolimus group had their tumour shrink or disappear according to independent reviewers. It is worth noting that more participants in the everolimus group did not complete the study compared to the cabozantinib group, which may be relevant context when reading these 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 ↗

  • NCT00934440 · results posted 14 June 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT00934440) enrolled 11 participants in a Phase I study looking at a drug called 5-Azacitidine. Ten of the 11 participants completed the study, and one did not. The main goal of this type of Phase I trial was to find the highest dose of the drug that could be given without causing unacceptable side effects — this is called the Maximum Tolerated Dose (MTD). Side effects were tracked using a standard medical grading system called the Common Terminology Criteria for Adverse Events (CTCAE), which is a set of rules researchers use to categorise and rate unwanted reactions to treatment. The reported data shows that across the different dose levels tested, the numbers of recorded adverse events (unwanted reactions) were 44, 48, and 49 respectively. It is worth noting that the data as submitted does not specify which dose level each of these three figures corresponds to, so a direct comparison between dose levels cannot be made from the information provided. For the secondary outcome, the reported data shows that the median time to progression — meaning the middle-point estimate of how long it took before the disease showed signs of getting worse, or before a participant passed away — was reported as 5.6 months. These results come from a small, early-phase trial with only 11 participants, and the figures above are simply the numbers that were recorded and submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00379340 · results posted 14 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 380 participants across five groups, all of whom had been diagnosed with Wilms' tumour (a type of kidney cancer) at an advanced stage. The trial was measuring "event-free survival" — that is, the probability that a participant would go four years without their cancer coming back, developing a new cancer, or dying. Different groups were defined by factors such as how their lung tumours responded to early treatment, whether the cancer had spread beyond the lungs, and certain biological markers in the tumour. The reported data shows the following four-year event-free survival probabilities for the main groups. Among participants whose lung tumours responded quickly and completely to initial treatment, the reported probability was 0.79 (meaning roughly 79 in every 100 people in that group had no such event over four years). For those whose lung tumours responded more slowly or incompletely, the reported probability was 0.89. For participants with certain tumour biology markers (loss of genetic material at specific locations, known as LOH 1p and 16q) who received a particular treatment regimen, the reported probability was 0.90, while for those with disease that had spread to areas other than the lungs and who received the same regimen, it was 0.73. For a secondary measure looking at the size of lung tumours, the reported data shows a probability of 0.88 for participants whose lung tumours were 1 centimetre or smaller, and 0.82 for those with tumours larger than 1 centimetre. 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 ↗

  • NCT00335556 · results posted 14 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 291 participants across six treatment groups: Surgery (68 people), UH-1 (98 people), Window/UH-1 (7 people), UH-2 (10 people), Regimen I (78 people), and Regimen DD-4A (30 people). The trial was measuring outcomes for children with certain rare kidney tumours — specifically a type called diffuse anaplastic Wilms' tumour and another called malignant rhabdoid tumour — looking at how long participants went without their disease getting worse (called "event-free survival"), how often tumours responded to treatment, and rates of certain serious side effects. The reported data shows the following figures for the main (primary) outcomes. For diffuse anaplastic Wilms' tumour, the four-year overall survival percentage was reported as 76.1% in the UH-1 group, 25.0% in the Window/UH-1 group, and 87.5% in the UH-2 group. For malignant rhabdoid tumour patients in the UH-1 group, the four-year overall survival figure was reported as 38.9%. In terms of how tumours responded during an early "window" treatment phase, the reported data shows a response rate (tumours that shrank significantly or disappeared) of 71% across the combined window groups. For participants on Regimen DD-4A, the four-year event-free survival probability was reported as 100%. Regarding serious side effects tracked as a primary outcome, the reported data shows 4.9% of participants in the combined UH groups experienced severe heart-related toxicity, 4.9% experienced a serious liver condition called Sinusoidal Obstruction Syndrome, and no treatment-related deaths were reported (0%). For a secondary (additional) outcome, 23 participants in the UH-1 group and 1 participant in the Window/UH-1 group were found to have a specific genetic change (INI1 mutation) in their tumour tissue, though the data for several other secondary outcomes 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.

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

  • NCT01034631 · results posted 24 May 2017

    According to the results reported on ClinicalTrials.gov, this trial took place in two stages. In Phase I, 15 people took part (12 completed that phase), with the goal of finding the highest dose of a drug called BNC105P that could be given alongside another drug called everolimus without causing unacceptable side effects. Phase II then enrolled a further 139 people, split into two groups: 70 people in Arm A received BNC105P and everolimus together, and 69 people in Arm B received everolimus first and then BNC105P on its own. The main thing Phase II was measuring was how many people had not seen their disease progress six months after starting treatment. The reported data shows that in Phase I, the highest tested dose that was taken forward was 16 mg/m² (a measure of drug dose adjusted for body size). Regarding side effects rated as moderate or worse in Phase I, the data lists counts of individual events across participants — the numbers reported range from 1 to 4 participants per type of event across twelve categories of side effects, though the specific names of those side effects were not included in the data provided here. For tumour response in Phase I, no participants had a complete response (full disappearance of tumours) or a partial response (meaningful shrinkage), 8 had stable disease (no significant change), 4 had progressive disease (tumours grew), and 3 were not assessed. The reported data shows that in Phase II, the probability of being free from disease progression at six months was approximately 0.34 (or about 34 in 100) for the combination group (Arm A) and approximately 0.30 (or about 30 in 100) for the sequential group (Arm B). In both Phase II arms, only 1 participant in each group had an objective tumour response (either complete or partial shrinkage confirmed by scans). 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 ↗

  • NCT00352534 · results posted 15 May 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 808 children in total — 211 with Stage I or II disease and 597 with Stage III disease — during an initial staging period. After further testing, participants were sorted into risk groups: Very Low Risk (119), Low Risk Stage I/II without a certain genetic marker called LOH (52), Standard Risk Stage I/II with LOH (32), Standard Risk Stage III (548), and High Risk (40). The trial was measuring how often children remained free from relapse, a second cancer, or death over four years, as well as how many were still alive at that point. The reported data shows that for the primary outcomes measured at four years, the probability of being "event-free" (meaning no relapse, second cancer, or death) was reported as 0.88 for the Very Low Risk group, 0.87 for the Standard Risk Stage I/II with LOH group, and 0.88 for the Standard Risk Stage III group — where a probability of 1.00 would mean every participant was event-free. For overall survival (being alive at four years), the reported probability was 1.00 for both the Very Low Risk and Standard Risk Stage I/II with LOH groups, and 0.97 for the Standard Risk Stage III group. Results for the Low Risk and High Risk groups were not reported in this data. The reported data also shows two secondary outcomes tracked only in the Very Low Risk group: one participant was found to have a lesion develop on the other (contralateral) kidney during follow-up, and zero participants experienced kidney failure requiring dialysis or a kidney transplant. No secondary outcome figures were reported for the other risk 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 ↗

  • NCT01305200 · results posted 9 May 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 226 people in total. Of these, 111 were assigned to a placebo mouth rinse and 112 to a rinse called supersaturated calcium phosphate (a solution containing minerals found naturally in saliva). Three additional people enrolled but were not placed in either group. The trial was measuring mouth sores — known as oral mucositis — which are a common and painful side effect of cancer treatment such as stem cell transplants. Specifically, the trial tracked how long severe mouth sores lasted, how many people developed them, patients' own daily ratings of their symptoms, and the use of strong pain medicines (opioids given through a drip or injection). The reported data shows that, for the main thing being measured — the average number of days participants experienced severe mouth sores — both groups recorded the same figure: 4.5 days. For the secondary measures, 68% of people in the placebo group and 63% in the rinse group were reported to have developed severe mouth sores. Regarding strong injectable pain medicines, 88.7% of the placebo group and 91.3% of the rinse group received them, with an average duration of use of 14.2 days (placebo) versus 12.5 days (rinse), and an average daily dose of 0.4 mg/kg/day (placebo) versus 0.3 mg/kg/day (rinse). The reported data also shows that patients' own daily symptom questionnaire scores (measured across several sub-areas) were generally similar between the two groups, with small numerical differences across the various sub-scales. 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 ↗

  • NCT01853046 · results posted 20 February 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 18 participants who had normal or mildly reduced kidney function, and 6 participants who had severely reduced kidney function. The trial was measuring how a cancer drug called regorafenib (also known as Stivarga) moves through the body in people with different levels of kidney function. Specifically, it tracked how much of the drug and two of its breakdown products (called M-2 and M-5) were present in the blood over time, and how much of two other breakdown products (M-7 and M-8) were passed out in the urine. No participants were recorded as having completed the study in the formal sense — all 24 were listed under "not completed," which in this type of pharmacokinetic (drug-behaviour) study typically reflects the study design rather than dropouts, though the data as reported does not explain this further. The reported data shows the following measurements after a single dose. For the main blood-exposure measure (how much drug was detected in the blood from the time of dosing until it was no longer measurable), the normal/mild kidney group recorded 67.2 mg·h/L for regorafenib itself, 27.8 for M-2, and 5.25 for M-5; the severe kidney group recorded 76.6, 19.0, and 2.34 respectively. For the amount of M-7 and M-8 passed out in urine in the first 24 hours (expressed as a percentage of the dose given), the normal/mild group recorded 3.607% for M-7 and 1.120% for M-8, while the severe kidney group recorded 1.309% and 0.184% respectively. Secondary measures — including the peak drug concentration in the blood and the time it took to reach that peak — were also reported across both groups, with figures broadly in a similar range between the two groups for most measures, though the full infinity-extrapolated blood-exposure figure for M-5 was not reported for either 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 ↗

  • NCT02829775 · results posted 17 November 2016

    According to the results reported on ClinicalTrials.gov, this trial looked at a single group of 9 people with cancer who received a medicine called Interferon Alfa-2A. Of those 9 participants, 4 completed the study and 5 did not complete it. The trial was measuring two main things: how many participants experienced serious unwanted medical events (called serious adverse events, or SAEs — these are significant medical problems such as hospitalisation, life-threatening situations, or death), and how many participants showed a response in their tumour over time. The reported data shows that 1 out of the 9 participants experienced a serious adverse event during the study. For the secondary outcome — tumour response — the data reports that 9 participants were assessed, with 0 recorded as having either a complete response (where the tumour disappears entirely) or a partial response (where the tumour shrinks noticeably). It is worth noting that this was a very small study with only 9 participants, which limits how much can be drawn from these numbers. 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 ↗

  • NCT00126594 · results posted 16 September 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 40 in each group. One group received a drug called sorafenib tosylate on its own, while the other group received sorafenib tosylate combined with a second drug called recombinant interferon alfa-2b. The trial was looking at how many participants' tumours shrank or disappeared (called the "objective response rate"), how long participants went without their disease getting worse, and how long they survived overall, among other measures. Only 1 person in the sorafenib-only group and 3 people in the combination group were recorded as having completed the study. The reported data shows that 30% of participants in the sorafenib-only group and 25% in the combination group had their tumours shrink or disappear according to the standard measurement criteria used (called RECIST). When looking at how long participants went without their disease progressing, the reported figures were approximately 7.4 months for the sorafenib-only group and 7.6 months for the combination group. For overall survival — the time from starting treatment until death or last follow-up — the reported median was 27 months for the combination group; the data was not reported for the sorafenib-only group. For participants across both groups whose disease stayed stable (37 people combined), the reported average duration of that stable period was approximately 5.7 months. The trial also tracked serious side effects (graded 3–4 in severity), with 10 to 13 participants in each group experiencing at least one such event depending on the type, though the full breakdown by side-effect category was not detailed in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00903175 · results posted 28 June 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT00903175) enrolled 469 people with kidney cancer, split into two groups. One group of 238 people received everolimus first, then switched to sunitinib if their disease progressed. The other group of 231 people received sunitinib first, then switched to everolimus. The trial was measuring how long people went without their disease getting worse, both on the first treatment and across both treatments combined, as well as how long people lived overall and how their cancer responded to treatment. The reported data shows that for the main measure — how long people went without their disease worsening on their first treatment — the everolimus-first group had a reported median of 7.85 months, compared to 10.71 months for the sunitinib-first group. (Median means half the people in the group had a result above this number and half below.) When both treatment periods were added together, the reported combined figures were 21.68 months for the everolimus-first group and 22.18 months for the sunitinib-first group. For overall survival — time from the start of the trial until death from any cause — the reported median was 22.41 months for the everolimus-first group and 29.47 months for the sunitinib-first group. In terms of tumour response during the first treatment, 19% of people in the everolimus-first group showed a measurable reduction in tumour size, compared to 62% in the sunitinib-first group. The reported data also shows that among those whose tumours did respond, the response lasted a reported median of 13.37 months in the everolimus-first group and 17.25 months in the sunitinib-first group. A separate measure tracked how long it took for participants to report a meaningful worsening of kidney cancer symptoms; this was reported as 12.65 months for the everolimus-first group and 16.66 months for the sunitinib-first 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 ↗

  • NCT00738530 · results posted 23 June 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 327 people in the bevacizumab plus interferon alfa-2a group and 322 people in the placebo plus interferon alfa-2a group — a total of 649 participants. The trial was measuring how long people lived overall, how long they went without their disease getting worse, and how many experienced disease progression or death. The reported data shows that, for overall survival — meaning how long participants lived from the start of the trial — the bevacizumab group had a reported median (the midpoint figure, where half lived longer and half lived shorter) of 23.3 months, compared with 21.3 months in the placebo group. Around 67% of participants in the bevacizumab group and around 70% in the placebo group had died by the time results were recorded. For progression-free survival — the time before the cancer grew noticeably worse or a person died — the reported median was 10.2 months in the bevacizumab group and 5.5 months in the placebo group. A similar measure called "time to progression" showed the same figures. Around 92% of participants in both groups experienced disease progression or death during the study period, and roughly 90–92% of both groups were recorded as having experienced treatment failure (which included progression, death, or stopping treatment for various reasons). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00465179 · results posted 4 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 57 participants, all of whom received a drug called sunitinib malate. The trial was measuring how their tumours responded to the treatment, how long it took before their disease progressed (got worse), and how long participants lived overall. Only 4 participants were recorded as having completed the study, while 53 did not complete it — though the data does not provide a breakdown of the reasons why. The reported data shows that when doctors assessed how participants' tumours changed during treatment, none of the 57 participants had a complete disappearance of their tumours (called a "complete response"). Three participants had their tumours shrink by at least 30% (called a "partial response"), 29 had their disease remain roughly stable without significant shrinkage or growth ("stable disease"), and 23 had their disease continue to grow ("progressive disease"). The reported data shows that the middle point — known as the median — for how long participants went without their disease getting worse was 2.7 months. This means that roughly half of participants reached that point sooner and half later. For the secondary outcome, the reported data shows that the median overall survival — that is, the midpoint for how long participants lived from the start of treatment — was 16.8 months. Again, this means roughly half of participants lived longer than this and half did not reach this point. 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 ↗

  • NCT01949532 · results posted 4 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people across two groups: 15 with normal kidney function and 11 with end-stage renal disease (kidneys that have largely stopped working). The trial was measuring how the body handles a drug called carfilzomib — specifically, how much of the drug gets into the bloodstream and how quickly it is cleared away. Fifteen participants in the normal kidney group and 11 in the end-stage renal disease group started the study; 12 and 8 respectively completed it, with 3 in each group not finishing. The reported data shows the primary measurements focused on the total "exposure" to carfilzomib — essentially how much drug was present in the blood over time (measured in units called ng\*h/mL, which reflect the drug's concentration multiplied by time). For participants with normal kidney function, this exposure figure was reported as 563 ng\*h/mL, while for those with end-stage renal disease it was reported as 747–752 ng\*h/mL. The reported data also shows that the peak level of drug in the blood was 1,389 ng/mL in the normal kidney group and 1,567 ng/mL in the end-stage renal disease group, with both groups reaching that peak at roughly the same time (about 28 minutes after dosing). The time the drug took to reduce to half its peak level ("half-life") was reported as approximately 0.34 hours in the normal kidney group and 1.25 hours in the end-stage renal disease group. The rate at which the body cleared the drug was reported as 179 litres per hour in the normal kidney group and 134 litres per hour in the end-stage renal disease 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 ↗

  • NCT01668784 · results posted 29 April 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01668784) enrolled 821 people with kidney cancer — 410 assigned to receive nivolumab (an immunotherapy medicine) and 411 assigned to receive everolimus (a different type of cancer medicine used as a comparison). The trial was primarily measuring how long participants lived overall after being randomly assigned to one of the two treatments. The study was stopped earlier than originally planned by the sponsor, Bristol-Myers Squibb, after an independent monitoring committee reviewed the data and found a pre-set statistical threshold had been crossed; that early analysis became the final analysis. The reported data shows that the median overall survival — meaning the point in time by which half of the participants in each group had died — was 25.0 months for the nivolumab group and 19.55 months for the everolimus group. For secondary outcomes, the reported data shows that 25.9% of participants in the nivolumab group and 6.1% in the everolimus group had their tumours shrink by a meaningful amount (either disappearing entirely or reducing in size by at least 30%). Among those whose tumours did shrink, that response lasted a median of 13.11 months in the nivolumab group and 10.18 months in the everolimus group. The time it took for a response to first appear was similar in both groups — about 3.55 months for nivolumab and 3.71 months for everolimus. Progression-free survival (the time before the disease worsened or a participant died) was reported as 4.21 months for nivolumab and 4.50 months for everolimus. The trial also measured survival according to a protein marker called PD-L1; some figures were reported for different expression levels, though the data as submitted does not provide a full breakdown of which specific subgroups each number corresponds 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 ↗

  • NCT01894256 · results posted 19 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 44 adults across three groups based on how well their kidneys were working: 15 people with normal kidney function, 15 with mild kidney impairment, and 14 with moderate kidney impairment. One person in the mild impairment group did not complete the study. The trial was measuring how the body processes a single dose of a drug called olaparib — specifically, how much of the drug gets into the bloodstream and how quickly the body clears it — across these three different groups. The reported data shows several measurements of how olaparib moved through participants' bodies. The peak level of the drug in the blood (the highest concentration reached) was reported as 7.23 micrograms per millilitre in the normal kidney group, 9.08 in the mild impairment group, and 9.98 in the moderate impairment group. The total amount of drug the body was exposed to over time was reported as 43.70 in the normal group, 70.56 in the mild group, and 76.44 in the moderate group (measured in micrograms per millilitre per hour). The time it took to reach that peak level was similar across all three groups — roughly 1.55 to 2.00 hours. The reported data also shows that the rate at which the body cleared the drug appeared lower in the impaired kidney groups (5.29 and 4.79 litres per hour) compared with the normal kidney group (7.60 litres per hour), and that the apparent "spread" of the drug through the body was reported as lower in the impaired kidney groups as well. 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 ↗

  • NCT00227760 · results posted 29 February 2016

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called cediranib maleate in people with cancer. A total of 44 participants took part, and all 44 completed the study. The trial was measuring two main things: how many participants had their cancer remain stable (without growing) for a meaningful period of time, and how many had a partial reduction in their tumour, both assessed using a standard set of measurement rules called RECIST (a widely used system for tracking changes in tumour size during cancer trials). The reported data shows that out of the 44 participants, 18 were recorded as having stable disease — meaning their cancer did not grow significantly during the study period — and 15 were recorded as having a partial response, meaning their tumour appeared to shrink to some degree according to the RECIST measurements. For the secondary outcome, the reported data shows a progression-free survival of 8.9 months on average — that is, the typical length of time participants went before their cancer was recorded as getting worse or before they left the study for another reason. It is worth noting that this trial had only one group, meaning there was no comparison group receiving a different treatment or a placebo, so the numbers above describe what was observed in participants receiving cediranib maleate 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 ↗

  • NCT00022633 · results posted 24 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people in total across two groups: 55 participants aged 70 or older (the "elderly cohort") and 10 participants under the age of 60 (the "younger cohort"). Both groups received a combination of two chemotherapy medicines — paclitaxel and gemcitabine — for metastatic bladder cancer (cancer that has spread beyond the bladder). One of the main things the trial was set up to measure was simply whether it was practical to recruit enough older patients to run a larger future study, with a target of enrolling at least 3 patients aged 70 or older per month. The reported data shows that 55 older patients were enrolled across the study period. For the older group specifically, 22% of participants were reported as having a confirmed response to treatment (meaning their tumours either disappeared completely or shrank by at least 30%). The reported data also shows that the average time before the disease progressed or worsened — known as "progression-free survival" — was 6 months for the older group, and the average overall survival (time from enrolment until death from any cause) was reported as 11 months. Regarding the self-completed questionnaires patients were asked to fill in, the reported submission rate was 98% across all three forms, which the trial counted as meeting its own target for feasibility. A number of participants in both groups also experienced serious side effects (graded as severe, life-threatening, or fatal), with small numbers of participants recorded against various individual side effect categories, though a full breakdown by side effect type was not provided in the data 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 ↗

  • NCT00721734 · results posted 9 December 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00721734) enrolled 50 people in total across five groups, based on how well their kidneys were working: 12 with normal kidney function, 12 with mild kidney impairment, 10 with moderate kidney impairment, 8 with severe kidney impairment, and 8 on dialysis. The trial was measuring how the body processes the drug carfilzomib — specifically, how quickly the drug is cleared from the bloodstream — in people with different levels of kidney function. Only a small number of participants in each group completed the full study (4, 0, 2, 2, and 2 respectively), with the majority not completing it. The reported data shows that the primary measurement — how quickly carfilzomib was cleared from the blood on the first day of the first treatment cycle — varied across groups. The reported clearance figures were 151 litres/hour for normal kidney function, 113 litres/hour for mild impairment, 288 litres/hour for moderate impairment, 170 litres/hour for severe impairment, and 170 litres/hour for the dialysis group. Clearance, in simple terms, means how much blood the body can "clean" of the drug each hour — a higher number means the drug left the bloodstream more quickly. Secondary measurements tracked clearance and peak drug levels (the highest amount of drug in the blood at one time) at later points in treatment. These figures also varied between groups and across time points, and for some later time points, data was only reported for some groups rather than all five. 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 ↗

  • NCT01223027 · results posted 6 November 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01223027) enrolled 570 people with kidney cancer — 284 received dovitinib plus best supportive care, and 286 received sorafenib plus best supportive care. Both groups also received best supportive care, meaning general symptom management alongside their assigned medicine. The trial's main goal was to measure how long participants went without their disease getting worse (called "progression-free survival"), and it also tracked how long participants lived overall, how their physical functioning changed, and how they felt based on their own symptom reports. The reported data shows that the median time before disease progression or death — as assessed by an independent radiology review — was 3.7 months in the dovitinib group and 3.6 months in the sorafenib group. When the treating doctors conducted their own review of scans, the reported figure was 3.9 months in both groups. For overall survival (the time from joining the trial until death from any cause), the reported median was 11.1 months in the dovitinib group and 11.0 months in the sorafenib group. Regarding tumour response, approximately 3.9% of participants in the dovitinib group and 3.8% in the sorafenib group showed a measurable reduction in their tumour. The time until participants' physical performance scores meaningfully declined was reported as 5.1 months for dovitinib and 5.7 months for sorafenib. For the patient-reported kidney cancer symptom score, the time until a meaningful worsening was reported as 4.9 months for dovitinib and 6.4 months for sorafenib. It is worth noting that only 10 participants in the dovitinib group and 9 in the sorafenib group were recorded as having formally "completed" the trial, with the large majority leaving before the study's end — the reasons for this are not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01827254 · results posted 30 April 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01827254) enrolled 61 people with advanced (metastatic) kidney cancer. Of those, 52 were considered evaluable — meaning their data could be fully assessed. The trial was looking at what happened when patients were treated with a medicine called sunitinib as their first treatment, then switched to other medicines, and in some cases had sunitinib again later (called a "re-challenge"). The main things being measured were how long patients went without their cancer getting worse (called progression-free survival), how long patients lived overall, and how many patients saw their cancer shrink or disappear. The reported data shows that, for the 52 evaluable patients, the average time on first-line sunitinib before the cancer got worse was 18.4 months. When patients later received sunitinib again as a re-challenge, that figure was 7.9 months. For the second-line treatments in between, the reported time before worsening was 5.0 months for one group of medicines and 6.2 months for another. The reported overall survival — the time from starting treatment until death — was 55.9 months. In terms of tumour response, 53.8% of patients showed a measurable shrinkage during first-line sunitinib, 15.4% during the re-challenge, and 75.0% during a third-line or later use of sunitinib. Regarding unwanted medical events, 24 participants were reported to have experienced adverse events (unexpected medical problems during the study) and 21 experienced serious adverse events (more significant problems such as hospitalisation). Only 2 of the 61 enrolled participants were recorded as having formally completed the study, with 59 not completing it; the reasons for non-completion 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 ↗

  • NCT00831844 · results posted 30 March 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled children and young people across nine different groups, each with a different type of cancer that had come back or had not responded to earlier treatment. These cancers included hepatoblastoma, synovial sarcoma, rhabdomyosarcoma, adrenocortical carcinoma, Ewing sarcoma, neuroblastoma (two separate groups), osteosarcoma, and Wilms tumour. A tenth group (retinoblastoma) was listed but had no participants enrolled. In total, 116 participants started the trial across all groups. The trial was primarily measuring how many participants' tumours showed a response to treatment — defined as either a complete response (tumour disappearing entirely) or a partial response (tumour shrinking significantly). The reported data shows that the number of participants evaluated for the primary outcome varied slightly from those who started, ranging from 9 to 19 people per cancer group. Across the groups, very few participants were reported to have had a tumour response. Specifically, only one participant in the rhabdomyosarcoma group recorded what appears to be a response, and small numbers of responses were noted in a couple of other groups, though the data as submitted is limited in detail. The reported data also shows that the vast majority of participants — all but two across the entire trial — did not complete the study, which is common in trials involving serious illnesses. It is worth noting that the results data submitted to ClinicalTrials.gov for this trial is incomplete in some areas, and full response-rate figures for several groups were not clearly reported, 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 ↗

  • NCT00918281 · results posted 9 June 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people who had solid tumours (either primary or ones that had spread to other parts of the body). It was a single-group study, meaning all participants received the same investigational imaging agent, called Fluciclatide Injection (also known as AH111585 [18F]). The main thing the trial was measuring was how consistently this agent showed up in tumours across two separate PET scans — a type of medical imaging — taken of the same person. Of the 70 people who started, 41 completed the study and 29 did not. The reported data shows that when tumour uptake of the imaging agent was measured using a value called SUV (Standardised Uptake Value — a number used to describe how much of an imaging agent is detected in a specific area), the readings were very similar between the two scanning sessions. Across the measurements reported, the first scan sessions produced SUV figures of approximately 4.5–4.6, and the second scan sessions produced figures of approximately 4.7, with the calculated relative difference (a way of expressing how much the two readings varied from each other) ranging from about 0.02 to 0.05. In plain terms, this suggests the two scans produced broadly similar numbers, though the reported data does not include full detail on all participants for each individual measurement. The reported data also shows that adverse events (unwanted medical occurrences recorded during the study) were tracked as a secondary measure. A total of 18 events were recorded in one category, with other categories recording figures including 47, 1, 3, 8, 7, 7, 0, 1, 2, and 0 — however, the data as submitted does not include labels explaining what each specific category of adverse event refers to, so a detailed breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00113217 · results posted 14 January 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom received a treatment called bevacizumab. All 50 participants completed the study with none recorded as having dropped out. The trial was looking at two things: how long participants went without their disease getting worse (called "progression-free survival"), and what side effects or toxic reactions occurred during treatment for a type of kidney cancer known as renal cell carcinoma. The reported data shows that the median progression-free survival — meaning the point at which half of the participants had experienced their disease worsening and half had not — was 11 months. This figure was measured from the time each participant started taking the study drug. Disease progression was defined as a 20% or greater increase in the size of tumours being tracked, a measurable increase in other disease areas, or the appearance of new areas of disease. Regarding the safety outcome (side effects and toxic reactions), the reported data does not include any numerical results in the submitted records — this information was not reported in the structured data available on 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 ↗

  • NCT00387764 · results posted 3 December 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people, all of whom received a daily oral dose of pazopanib (800 mg). The trial was measuring the safety and tolerability of the drug — in other words, it was tracking what unwanted medical events participants experienced while taking it, how severe those events were, and how long people stayed on the treatment. Forty-nine of the 80 participants completed the study, while 31 did not. The reported data shows that 78 out of 80 participants experienced at least one unwanted medical event (called an adverse event) of any kind, and 27 out of 80 experienced a serious adverse event — meaning one that was life-threatening, required hospitalisation, or caused significant disability. When those events were sorted by severity, 12 participants had mild events, 33 had moderate events, 22 had severe events, 7 had life-threatening or disabling events, and 4 participants died during the study period. Seventy out of 80 participants had at least one unwanted event that the investigators considered possibly related to the study drug. The reported data also shows that the middle value (median) for time spent on the treatment was 9.7 months. In terms of blood test changes, varying numbers of participants showed worsening results for liver, kidney, and blood-count measures at different severity levels; for example, changes in liver enzyme readings (ALT and AST) of at least moderate severity were seen in a small number of participants, and low white blood cell counts of at least severe grade were recorded in a small number as well. 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 ↗

  • NCT00720941 · results posted 17 June 2013

    According to the results reported on ClinicalTrials.gov, this trial compared two medicines — pazopanib (800 mg) and sunitinib (50 mg) — in people with kidney cancer. A total of 557 people were assigned to the pazopanib group and 553 to the sunitinib group, making it a large trial of over 1,100 participants. The main thing the trial was measuring was "progression-free survival" — that is, how long patients went without their cancer getting worse or without dying. The reported data shows that, on average, people in the pazopanib group went 8.4 months before their cancer progressed or they died, compared with 9.5 months in the sunitinib group. For overall survival (how long people lived in total from the start of the trial), the reported figures were 28.3 months for the pazopanib group and 29.1 months for the sunitinib group. Looking at tumour response, 170 people in the pazopanib group and 134 in the sunitinib group showed a partial response (meaning their tumours shrank by at least 30%), while 1 and 3 people respectively showed a complete response (tumours disappearing entirely). The time it took to first see a response was reported as approximately 11.9 weeks for pazopanib and 17.4 weeks for sunitinib. Once a response occurred, it lasted a reported average of 13.8 months in the pazopanib group and 18.0 months in the sunitinib group. Regarding adverse events (unwanted side effects), the reported data shows that 551 out of 554 people in the pazopanib group and 535 out of 548 in the sunitinib group experienced at least one adverse event, with serious adverse events reported in 242 and 227 people respectively. No further breakdown of specific adverse events was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00631371 · results posted 4 June 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 791 people in total — 400 in one group and 391 in the other. Participants were randomly assigned to receive either a combination of two medicines called bevacizumab and temsirolimus, or a combination of bevacizumab and interferon-alfa. The main thing the trial was measuring was "progression-free survival" — that is, how long participants went without their disease getting worse or without dying, based on scans reviewed by an independent panel. The reported data shows that, based on the independent reviewers' assessment, the median time without disease progression was 9.1 months for the bevacizumab-plus-temsirolimus group and 9.3 months for the bevacizumab-plus-interferon-alfa group. (Median means half the participants had longer times and half had shorter times.) When the treating doctors assessed the scans themselves, the reported figures were 9.1 months and 10.8 months respectively. The trial also reported that around 27% of participants in both groups showed a measurable shrinkage in their tumour — 27.0% in the temsirolimus group and 27.4% in the interferon-alfa group. For overall survival (how long participants lived from the start of the trial), the reported median figures were 25.8 months in the temsirolimus group and 25.5 months in the interferon-alfa group. It is worth noting that no participants were recorded as having "completed" the study in the formal sense, meaning all participants either withdrew, experienced disease progression, or were otherwise removed from the trial before a formal completion milestone was reached. 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 ↗

  • NCT00471536 · results posted 21 March 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people, all of whom received the same treatment — a drug referred to as an enzyme inhibitor (GW786034). The trial was measuring how well the treatment reduced tumour size in participants, using a standard set of rules called RECIST to judge whether tumours had shrunk or disappeared. Eighteen of the 19 participants completed the study, and one did not. The reported data shows that, for the primary goal of the trial — seeing whether any participants' tumours disappeared entirely or shrank by at least 30% — the number recorded was zero out of 19 participants for both categories (complete disappearance and significant shrinkage). The secondary measure of confirmed tumour response also recorded zero participants meeting that threshold on two separate checks. For side effects that were considered at least possibly related to the treatment, the reported data shows 7 participants experienced side effects of the highest recorded grade, while zero were recorded in another side-effect category; however, the data as submitted does not break down the specific types of side effects in detail. The reported data also shows that the estimated median time before disease progressed was 1.85 months, and the estimated median survival time was 5.83 months. No figures for duration of response 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT00490698 · results posted 18 March 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, all of whom received a combination of two medications — zoledronate and atorvastatin. The trial was measuring how long it took for participants to experience their first "skeletal-related event," which the study defined as a bone complication such as a fracture, spinal cord compression, or a situation where a bone metastasis (cancer that has spread to the bone) required radiotherapy or surgery. Participants were monitored every 8 weeks for at least one year. The reported data shows that only 1 out of the 11 participants who started the trial completed it, with 10 participants not completing the study. Because of this very low completion rate, the results should be read with that context in mind. The reported outcome shows a median time to first skeletal-related event — meaning the midpoint figure for how long it took before such an event occurred — of 9 months. No other outcome measures were reported in the submitted data. It is worth noting that with only 11 participants starting and just 1 completing the trial, the reported data is very limited and no data on secondary outcomes was reported in the submission. 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 ↗

  • NCT00474786 · results posted 7 March 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT00474786) enrolled 512 people with cancer — 259 received a medicine called temsirolimus and 253 received a medicine called sorafenib. The trial's main goal was to measure **progression-free survival (PFS)** — that is, how long participants went without their disease getting worse or dying. A secondary goal was to look at overall survival (how long participants lived), how many had their tumour shrink, and how long any shrinkage lasted. The reported data shows that, for the primary measure, the median time before disease progression or death was 4.28 months in the temsirolimus group and 3.91 months in the sorafenib group. (Median means half the participants reached that point sooner, and half took longer.) When the treating doctors — rather than an independent review panel — assessed disease progression, the reported figures were 5.43 months for temsirolimus and 4.14 months for sorafenib. For overall survival, the reported median was 12.27 months in the temsirolimus group and 16.64 months in the sorafenib group. Regarding tumour shrinkage, approximately 7.7% of participants in the temsirolimus group and 7.9% in the sorafenib group were reported to have had a confirmed reduction in tumour size. Among those who did respond, the reported median duration of that response was 8.26 months for temsirolimus and 6.96 months for sorafenib. No participants were recorded as having "completed" the study in the conventional sense, as the data shows all participants fell under the "not completed" category, which is common in trials that track participants until an event such as disease progression occurs. 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 ↗

  • NCT00410124 · results posted 15 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 416 people with advanced kidney cancer across two groups. The larger group — 277 people — received a medicine called RAD001 (also known as everolimus) alongside best supportive care (meaning standard symptom management). The other 139 people received a placebo (a dummy pill with no active ingredient) alongside best supportive care. The trial was mainly measuring how long people went without their disease getting worse, and it later moved into an open-label extension phase where participants could receive RAD001. The reported data shows that the main outcome — called "progression-free survival," meaning the time from the start of treatment until the disease was recorded as getting worse or a participant died — was a median (middle value across the group) of 4.90 months in the RAD001 group, compared to 1.87 months in the placebo group. For overall survival (time from the start of the trial until death from any cause), the reported median figures were 13.57 months for the RAD001 group and 13.01 months for the placebo group. The proportion of participants whose tumours shrank to a defined level (complete or partial response) was reported as 1.8% in the RAD001 group and 0% in the placebo group. Duration of response data was not reported for either group. The reported data also shows two quality-of-life measures. The time until participants experienced a meaningful, lasting drop in their general quality-of-life score was a median of 4.76 months in the RAD001 group versus 3.91 months in the placebo group. Similarly, the time until a meaningful, lasting worsening of kidney-cancer-related symptoms was reported as 4.76 months in the RAD001 group versus 3.84 months 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 ↗

  • NCT00550277 · results posted 30 November 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00550277) enrolled 20 participants, all of whom received the study treatment, panobinostat. The trial was measuring how long participants went without their disease getting worse (called progression-free survival), as well as tracking side effects and whether participants' tumours shrank or disappeared during treatment. Of the 20 people who started, 11 completed the study and 9 did not. The reported data shows that the median progression-free survival — that is, the midpoint time at which half of participants had experienced disease progression or death — was 1.7 months. Regarding side effects, 15 out of 20 participants experienced adverse events (unwanted medical developments) that were related to the study drug and were rated Grade 2 or higher, meaning they were at least moderate in severity. For overall response — meaning tumours either partially shrinking or completely disappearing — the reported data shows that 0 out of 20 participants met that measure. The reported data shows no participants experienced a complete or partial tumour response as defined by the study's criteria. It is worth noting that 9 participants did not complete the trial, though the reasons for this are not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00065468 · results posted 25 October 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00065468) enrolled 626 people across three groups: 207 received interferon alfa (a type of immune-based treatment), 209 received temsirolimus (a targeted medicine), and 210 received a combination of both. The trial was measuring how long participants lived overall, how long they went without their disease getting worse, and whether their tumours responded to treatment. The reported data shows that for overall survival — the time from entering the trial until death — the interferon alfa group had a median (middle value) of 7.3 months, the temsirolimus group had 10.9 months, and the combination group had 8.4 months. For progression-free survival — the time until the disease got worse or death — the figures were 3.2 months, 5.6 months, and 4.9 months respectively. When it came to the percentage of participants whose tumours showed a measurable shrinkage, the reported data shows 5.3% in the interferon alfa group, 9.1% in the temsirolimus group, and 9.5% in the combination group. A broader measure called "clinical benefit" — which also included people whose disease stayed stable for at least 24 weeks — was reported as 16.4%, 34.0%, and 30.0% for the three groups. The reported data also shows that among those whose tumours did respond, the response lasted a median of 7.4 months (interferon alfa), 11.1 months (temsirolimus), and 9.3 months (combination). The time to treatment failure — meaning the time until the treatment stopped being used for any reason — was reported as 1.9 months, 3.7 months, and 2.5 months across the three groups. It is worth noting that zero participants were recorded as having "completed" the study in the formal sense, which is not uncommon in trials where the endpoint is tracked over time rather than a fixed finish point. 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 ↗

  • NCT00423332 · results posted 6 September 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people in total — 53 received a drug called AZD2171 (at a dose of 45 mg) and 18 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in tumour size and how long those changes lasted in people with cancer. Participants were assessed using a standard set of rules for measuring tumours called RECIST, which looks at the combined length of target tumours at different points in time. The reported data shows that, at 12 weeks, tumours in the AZD2171 group had shrunk on average by about 19.5% from their starting size, while tumours in the placebo group had grown on average by about 19.7%. Looking at the best result recorded at any point during the study, the AZD2171 group showed an average reduction of around 26.9%, compared with an average increase of about 1.1% in the placebo group. The reported data also shows that 11 out of 53 participants in the AZD2171 group met the criteria for a measurable response (either complete or partial tumour shrinkage) at 12 weeks, compared with 0 out of 18 in the placebo group. Over the whole study, 18 participants in the AZD2171 group and 1 in the placebo group met those response criteria at their best recorded point. The reported data shows that the median time before tumours progressed or participants died (known as "progression-free survival" — roughly, the length of time the disease did not get worse) was reported as 12.1 months for the AZD2171 group and 2.76 months for the placebo group. Among those who did show a measurable response, the reported duration of that response was approximately 18.6 months for the AZD2171 group and 11.1 months for the placebo group. It should be noted that these figures describe what was recorded and reported in this specific trial; they do not speak to what any individual might 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 ↗ · Linked publication on PubMed ↗

  • NCT00001703 · results posted 14 June 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received a treatment called VHL Peptide combined with an adjuvant called ISA-51 (an adjuvant is a substance added to help stimulate the body's immune system). The trial was measuring whether this combination prompted an immune response in participants — specifically, whether certain immune cells became more active after vaccination compared to before. Only 1 participant was recorded as having fully completed the trial, with 3 leaving when the peptide supply ran out, and a total of 5 not completing the study for various reasons. The reported data shows that the primary outcome — the percentage of participants who showed an immune response — was recorded as 80%. This was measured using a laboratory test called an ELISPOT, which detected whether immune cells were more active after vaccination than before. A positive result was defined as post-vaccination activity being more than double the pre-vaccination level. It is worth noting that because only 6 people started the trial and just 1 formally completed it, these percentage figures are based on a very small number of people. For the secondary outcome, the reported data shows that 5 out of the 6 participants experienced at least one adverse event (an adverse event meaning any unwanted or unexpected health occurrence noted during the trial). The trial record notes that a more detailed breakdown of those adverse events is listed separately in the adverse events section of the trial record, which was 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 ↗

  • NCT00678392 · results posted 27 March 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 361 people in the axitinib group and 362 people in the sorafenib group — a total of 723 participants with advanced kidney cancer. The trial compared two medicines, axitinib (5 mg) and sorafenib (400 mg), and measured several things: how long people went without their cancer growing (called progression-free survival), how long people lived overall, how many people's tumours shrank, how long those responses lasted, and what unwanted medical events occurred during treatment. The reported data shows that, for the main measure — time until the cancer grew or the person died — the axitinib group had a reported median (the midpoint value across all participants) of 6.7 months, compared with 4.7 months in the sorafenib group. For overall survival, the reported median was 20.1 months in the axitinib group and 19.2 months in the sorafenib group. When looking at tumour shrinkage, 19.4% of participants in the axitinib group and 9.4% in the sorafenib group were reported to have had a confirmed response. Among those whose tumours did shrink, the response lasted a reported median of 11.0 months (axitinib) and 10.6 months (sorafenib). The reported data also shows that unwanted medical events during treatment were recorded for 96.1% of axitinib participants and 98.0% of sorafenib participants. Serious adverse events — meaning more significant medical events such as hospitalisation — were reported in 40.7% of the axitinib group and 35.8% of the sorafenib group. Note that 0 participants in either group were recorded as having "completed" the study, which the data indicates means all participants either stopped early or were otherwise not completing per protocol; the data does not provide further explanation for this. 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 ↗

  • NCT00129961 · results posted 23 March 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 86 people in total — 39 in a group receiving a sirolimus (SRL) based medication regimen and 47 in a group receiving a calcineurin inhibitor (CNI) based regimen. Both groups were already transplant recipients who had previously developed non-melanoma skin cancers (NMSCs) — a category that includes two common skin cancer types: squamous cell carcinoma (SCC) and basal cell carcinoma (BCC). The trial was measuring whether the type of anti-rejection medication a person took was linked to differences in how often new skin cancers appeared. Around half of participants in each group did not complete the study (19 in the SRL group and 23 in the CNI group). The reported data shows that the main thing being tracked — the rate of new, biopsy-confirmed (meaning confirmed by a tissue sample test) skin cancer lesions per person per year — was recorded as 1.31 in the sirolimus group and 2.48 in the CNI group. For the secondary measures, the reported data shows the average number of days until a first new skin cancer lesion was confirmed was 380 days in the sirolimus group and 163 days in the CNI group. The reported data also shows that 17 out of 39 participants in the sirolimus group had no new lesions during the study, compared with 9 out of 47 in the CNI group. The rate of skin cancers that came back at a previously treated spot was reported as 0.107 lesions per person per year in the sirolimus group and 0.134 in the CNI group. The breakdown between SCC and BCC lesion types was broadly similar between the two groups (around 67–69% SCC and 31–33% BCC). 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 ↗

  • NCT00425386 · results posted 16 February 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people, all of whom received a combination of two medicines — sunitinib and erlotinib — for metastatic or inoperable kidney cancer (either clear cell or papillary type). Forty-three participants completed the study. The trial had two main goals: to find the highest dose of erlotinib that could be given alongside sunitinib without causing too many serious side effects (known as the "maximum tolerated dose"), and to measure how many participants were still free from their cancer getting worse after 8 months of treatment. The reported data shows that the maximum tolerated dose of erlotinib when used with sunitinib was identified as 50 mg, with 150 mg noted as a separate dose level tested. Regarding the 8-month progression-free result, 40% of participants were reported to be free from their cancer worsening at that point. For secondary measures, the reported median time until the cancer progressed was 5.8 months (meaning half of participants reached that point before 5.8 months and half after). Looking at best overall tumour response, the reported data shows 22% of participants had a partial response (tumour shrank by at least 30%), 59% had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), and 11% had progressive disease (cancer continued to grow). The maximum reported change in tumour size across participants was an 18% reduction. Safety-related data was also collected, with participant counts across various recorded events ranging from 12 to 35 people, though the specific descriptions of those events were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00523640 · results posted 22 December 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received a combination of three medicines: gemcitabine, capecitabine, and bevacizumab. Twenty-nine of the 30 participants completed the study. The trial was measuring how often tumours visibly shrank or disappeared on scans, how long participants went without their disease getting worse, and how long participants lived overall. The reported data shows that 0.24 (or roughly 24 in every 100 participants, based on the proportion reported) had their tumour either disappear completely or shrink by at least 30% on scans — this is what the researchers called an "objective response." The reported data also shows that, on average, participants went approximately 5.3 months before their disease showed signs of getting worse — a measure the trial called "progression-free survival." This simply means the length of time from when someone joined the trial until their cancer was recorded as progressing. For the secondary outcome, the reported data shows that the average time from enrolment until death from any cause — referred to as "overall survival" — was approximately 9.8 months. It is important to note that these figures represent averages across the group of participants in this single trial, and no comparison group (such as a placebo or different treatment group) was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00073307 · results posted 14 December 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 903 people across two main groups: 451 received sorafenib (also known as Nexavar or BAY43-9006) and 452 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how long participants lived overall, how long they went without their disease getting worse, how their tumours responded to treatment, and how they felt in terms of quality of life. After the initial blinded phase ended, participants who had been on placebo were given the option to switch to sorafenib in an open-label phase. The reported data shows that, on average, participants in the sorafenib group lived for 542 days from the time they entered the trial, compared with 461 days in the placebo group (or 436 days when the placebo data was adjusted to account for those who later switched to sorafenib). For progression-free survival — meaning the time before the disease got worse or a participant died — the reported figure was 167 days for the sorafenib group and 84 days for the placebo group. Looking at how tumours responded, the reported data shows no participants in either group had their tumour disappear completely; a small number (2.1%) in the sorafenib group had their tumour shrink partially, compared with none in the placebo group; and around 78% of the sorafenib group had stable disease (tumour neither growing nor shrinking noticeably), compared with 55% in the placebo group. The reported data shows that scores on the quality-of-life questionnaires — which measured how participants felt physically and day-to-day on a numbered scale — were very similar between the sorafenib and placebo groups across the first five treatment cycles, with no notable difference recorded between the two groups at any of the measured time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00338884 · results posted 14 June 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people, all of whom received the study drug sunitinib (119 actually received treatment). The trial involved only one group — there was no comparison group. It was measuring how many participants' tumours shrank or disappeared, and tracking how long those responses lasted, how long before tumours grew again, and how long participants survived. The reported data shows that out of 119 people who received treatment, 41 participants had their tumours either disappear completely or shrink by at least 30% (and stay that way for at least four weeks). Among those 41 people who had a recorded response, the reported average length of that response was approximately 7.1 months. The reported median time before tumours began growing again was 10 months, and the related measure of progression-free survival (the time participants lived without their disease worsening or dying) was reported as 9 months. The one-year survival rate — meaning the proportion of participants still alive one year after starting treatment — was reported as approximately 67.8%. The trial also measured the level of sunitinib in participants' blood at various points; those figures ranged across different timepoints and were not described in a way that allows plain summary beyond noting the data was collected and reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00244764 · results posted 25 January 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 225 people, all of whom received a daily oral dose of pazopanib (800 mg). The trial was measuring how tumours responded to the treatment, using a standard system called RECIST, which classifies tumour changes into categories — from complete disappearance of the tumour through to the tumour growing. Of the 225 who started, 129 completed the study and 96 did not. The reported data shows that, out of all 225 participants, 3 had a complete response (meaning all detectable tumour disappeared) and 75 had a partial response (meaning their tumours shrank by at least 30%). A further 101 participants had stable disease (meaning the tumour neither shrank enough to count as a response nor grew enough to count as progression), while 24 experienced progressive disease (tumour growth of 20% or more). The data also included an early check-in of the first 60 participants at 12 weeks: at that point, 23 had a partial response, 25 had stable disease, 3 had progressive disease, and none had a complete response. For participants whose tumours did respond, the reported data shows the response lasted a median (middle value in the range) of 68 weeks. The reported median time before the disease progressed or death occurred — across all participants — was 45.3 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00334282 · results posted 2 August 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 435 people with a type of kidney cancer — 290 received a daily oral tablet called pazopanib (800 mg) and 145 received a placebo (a dummy tablet with no active ingredient). The main thing being measured was **progression-free survival** — that is, how long participants went before their disease got worse or they passed away. A number of secondary measurements were also tracked, including how long participants lived overall, how many showed a measurable reduction in tumour size, and how quickly any such response appeared. The reported data shows that, on average, participants in the pazopanib group went 9.2 months before disease progression or death, compared with 4.2 months in the placebo group, as assessed by an independent imaging review panel. For overall survival (total time from the start of the trial until death), the reported figures were 22.9 months for the pazopanib group and 20.5 months for the placebo group. Regarding tumour response, the reported data shows that 1 participant in the pazopanib group had a complete response (all detectable tumour disappeared) and 87 had a partial response (tumour shrank by at least 30%), compared with 0 and 5 participants respectively in the placebo group. Among those in the pazopanib group who showed a response, the reported duration of that response was approximately 58.7 weeks, and the time from the start of the trial until a response was first recorded was approximately 11.9–12.0 weeks. Duration of response data was not reported for 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 ↗

  • NCT00083889 · results posted 10 December 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 375 people in each group — one group received a medicine called SU011248 (also known as sunitinib) and the other received a medicine called IFN-α (interferon-alfa). The trial was measuring how long people went without their cancer growing or spreading (called "progression-free survival"), how many people's tumours shrank or disappeared, and how long people lived overall. The reported data shows that, for the main outcome — the time before the cancer progressed or a person died — the SU011248 group had a median (meaning the midpoint value across all participants) of 48.3 weeks, compared with 22.1 weeks in the IFN-α group. For the number of participants whose tumours shrank or disappeared according to a central radiology review, 145 out of 375 people in the SU011248 group had this response, compared with 29 out of 375 in the IFN-α group. When the treating doctors made their own assessments, those numbers were 171 and 45 respectively. The reported median overall survival (time from the start of the trial until death from any cause) was 114.6 weeks for the SU011248 group and 94.9 weeks for the IFN-α group. The time specifically until the tumour was first recorded as growing was also reported at around 49 weeks for SU011248 and around 22 weeks for IFN-α, across both the central radiology and doctors' own assessments. 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 ↗

  • NCT00077974 · results posted 3 November 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people, all of whom received a medicine called sunitinib malate. Only 2 participants were recorded as completing the study, while 104 did not complete it — though the data does not explain the reasons for this in detail. The trial was set up to measure how many participants' tumours shrank or disappeared according to a standard set of criteria (called RECIST), and to track how long it took for tumours to grow, how long any shrinkage lasted, and how long participants lived. The reported data shows that out of 106 participants, 35 were recorded as having a confirmed response — meaning their tumours either disappeared completely or shrank by at least 30%. The reported data shows that, on average, it took approximately 46.3 weeks from the start of treatment before tumours began to grow again or participants died from cancer. For the 35 people whose tumours did respond, the reported shrinkage lasted an average of around 60.4 weeks. The reported average time from the start of treatment until tumours grew or participants died from any cause (called progression-free survival) was 38.0 weeks, while the average time from the start of treatment until death from any cause (overall survival) was reported as 104.1 weeks. The reported data also shows an estimated 67.2% chance of survival at one year after starting treatment, and a 50.2% chance at two years — these figures are probabilities based on the group as a whole and do not predict what would happen to any individual person. 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 ↗

  • NCT00137423 · results posted 8 July 2009

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called sunitinib malate (also known as SU011248) in people with a type of kidney cancer. A total of 107 participants took part — 54 were assigned to take their dose in the morning and 53 in the evening. The trial was mainly measuring how many participants showed a measurable shrinkage in their tumours, and also tracked things like how long any tumour response lasted, how long before the cancer progressed, overall survival, and self-reported fatigue levels. The reported data shows that, for the primary outcome (tumour shrinkage meeting set criteria), 15 out of 54 participants in the morning-dose group and 6 out of 53 in the evening-dose group met that measure. For how long that tumour response lasted, the reported median (the middle value when all results are lined up) was around 24 weeks for the morning group and 32 weeks for the evening group. The time before the cancer showed signs of progressing was reported as approximately 35.7 weeks for the morning group and 35.9 weeks for the evening group, with very similar figures also reported for progression-free survival (35.7 and 35.3 weeks respectively). Overall survival — the time from starting the medicine until death from any cause — was reported as a median of around 91.4 weeks for the morning group and 76.4 weeks for the evening group. A fatigue questionnaire (scored out of 52, where higher means less fatigue) showed scores in the high 30s to low 40s across both groups at various time points, though a breakdown by exact time point was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

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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.