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Reported trial results for Brain Cancer

Every Brain 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.

111 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

  • NCT02595905 · results posted 8 April 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 344 people with breast cancer — 170 in a group receiving cisplatin (a chemotherapy) plus a placebo, and 174 in a group receiving cisplatin plus veliparib (a drug being tested). The trial was measuring how long people went without their cancer getting worse (called "progression-free survival"), how long people lived overall ("overall survival"), how many people's tumours shrank or disappeared ("response rate"), and how many people experienced some level of benefit ("clinical benefit rate"). Participants were divided into sub-groups based on whether they carried a BRCA gene mutation or not. The reported data shows that for progression-free survival, the three sub-groups showed median times (the point at which half the participants had experienced progression) ranging from 3.0 to 6.4 months in the cisplatin-plus-placebo group and 4.0 to 6.2 months in the cisplatin-plus-veliparib group. For overall survival, the reported median times ranged from 11.1 to 15.6 months in the placebo group and 10.9 to 14.2 months in the veliparib group across the three sub-groups. For response rate (tumour shrinkage), 12 and 8 participants in the two placebo sub-groups showed a response, compared with 21 and 8 participants in the corresponding veliparib sub-groups. For clinical benefit, 20 and 21 participants in the placebo sub-groups and 26 and 23 in the veliparib sub-groups were reported to have experienced some clinical benefit. No completion data was reported for either group in the trial records. It is worth noting that the data as submitted does not clearly label which specific measurements correspond to which sub-group (BRCA mutation carriers, BRCA-like, or non-BRCA-like), so the figures above are presented in the order they appear in the reported 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 ↗

  • NCT03475186 · results posted 13 March 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT03475186) enrolled 75 participants, all of whom received the drug ramipril. The trial was measuring changes in brain function — specifically memory, attention, processing speed, and verbal fluency — in people undergoing radiotherapy (radiation treatment), most likely for a brain tumour. These thinking and memory skills were tested at the start of the trial and again about 10 weeks later (one month after radiotherapy finished). By that 10-week point, 56 participants had completed the assessments. The results from the ramipril group were compared against a historical comparison group — people from a separate, earlier trial (called RTOG 0825) who did not receive ramipril. The reported data shows that brain function was measured using several standard tests, and the scores were converted into a standardised format (called a "z score") where zero represents an average score, positive numbers mean above average, and negative numbers mean below average. For word learning and memory (the HVLT-R test), the ramipril group's scores changed by +0.09 (total recall), 0.00 (delayed recall after 20 minutes), and −0.23 (word recognition) from their starting scores. The historical comparison group's scores changed by −0.40, −0.60, and 0.00 on those same measures. For attention and processing speed (Trail Making Test Part A), the ramipril group changed by +0.35 compared to +0.30 in the comparison group. For the more complex thinking task (Trail Making Test Part B), the ramipril group changed by +0.33 compared to 0.00. For verbal fluency (the COWA test), the ramipril group changed by +0.20 compared to 0.00. 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 ↗

  • NCT03868943 · results posted 21 October 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03868943) looked at a medication called solriamfetol in people with cancer-related fatigue and sleep problems. Only 2 participants were enrolled in the study, and only 1 of them completed it. Because so few people took part, the results are extremely limited in what they can tell us. The trial was measuring serious unwanted health events (called "grade 3 or higher adverse events," meaning moderate-to-severe reactions on a standard medical rating scale), as well as sleep quality, daytime sleepiness, fatigue, mood, and thinking and concentration abilities. The reported data shows that, for the primary outcome — the number of participants who experienced a serious adverse event of grade 3 or higher — the recorded figure was zero out of the two participants. For the secondary outcomes, the data was reported as participant counts across different score categories rather than individual scores, and most categories showed either 0 or 2 participants. For the neurocognitive battery (the thinking and concentration tests), no measurements were reported at all, meaning that data was not available. For the sleep quality questionnaire (PSQI), daytime sleepiness scale (Epworth), fatigue scale (Cancer Fatigue Scale), and depression questionnaire (Beck's Depression Inventory), the reported data shows very small counts across the scoring categories, consistent with only 1–2 participants contributing data. Because only 2 people were enrolled and just 1 completed the trial, the reported figures carry very little weight and cannot be used to draw any broad conclusions about this medication. 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 ↗

  • NCT03137888 · results posted 3 August 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, and all 30 completed the study. The trial was testing a type of brain cancer treatment that used a specialised MRI scanning technique (called structural MRI, or sMRI) to help guide radiation therapy, which was given alongside a chemotherapy medicine called temozolomide (TMZ). The trial was primarily looking at two things: whether the sMRI scans could be successfully matched up with standard clinical images and loaded into the radiation treatment system in a practical way, and how many unwanted side effects (adverse events) occurred during treatment. The reported data shows that all 30 participants had their sMRI-based treatment plans successfully transferred into the radiation delivery system — meaning the technical process worked for every person enrolled. A total of 79 adverse events were recorded across the group using a standard medical checklist (Common Terminology Criteria for Adverse Events, version 4.0), though the data as reported does not break these down further by type or severity. For the secondary outcome, the reported median progression-free survival — that is, the midpoint time before the condition showed signs of worsening — was 16.6 months. An additional measure recorded median overall survival at 23 months, meaning half of participants were alive beyond that point and half were not, based on follow-up of at least two and a half years from the start of radiation therapy. 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 ↗

  • NCT02514915 · results posted 26 June 2025

    According to the results reported on ClinicalTrials.gov, 24 people took part in this trial, and all 24 completed it. The trial looked at a type of precisely targeted radiation treatment called stereotactic radiosurgery. It measured two main things over time: first, whether tumours stayed under control (meaning they did not grow significantly compared to their size at the start of treatment); and second, how many participants were still alive at set points in time after treatment began. The reported data shows that when it came to tumour control, around 82 in every 100 participants (a proportion of 0.817) had their tumour considered locally controlled at both the 6-month and 12-month marks. By 24 months, that figure had dropped slightly, with approximately 75 in every 100 participants (0.749) still showing local tumour control. For overall survival — that is, the proportion of participants still alive — the reported data shows approximately 71 in 100 (0.708) were alive at 6 months, around 63 in 100 (0.625) at 12 months, and 50 in 100 (0.500) at 24 months. It is important to note that this trial involved only one group of participants, all of whom received the same treatment, so there was no comparison group. The figures above simply describe what was recorded for this particular group of 24 people at different points in time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04406272 · results posted 10 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04406272) enrolled 15 people across three groups. Group A (6 people) received VB-111 both before and after surgery; Group B (4 people) received a placebo before surgery and then VB-111 after surgery; and Group C (5 people) received a placebo before surgery and then standard care after surgery. The trial was measuring things like immune cell activity in tumour tissue, serious unwanted health events (called serious adverse events, or SAEs), how many participants showed no sign of disease progression six months after surgery, and how many participants were still alive over the course of the study. The reported data shows that for the main (primary) measure of immune cell density in tumour tissue, no data was collected or analysed — the trial team noted this testing was not performed and will not be performed. For the other primary measure — the number of participants who experienced a reportable serious adverse event — the reported figures were 3 out of 6 in Group A, 1 out of 4 in Group B, and 2 out of 5 in Group C. For the secondary measure of progression-free survival at six months (meaning no detectable worsening of disease at that point), 1 participant in Group A, 1 in Group B, and 0 in Group C met that mark. The reported overall survival data shows multiple counts across the groups, but the breakdown as submitted does not clearly separate the survival time-points, so a straightforward plain-English summary of those specific figures cannot be provided without risk of misrepresenting 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 ↗

  • NCT02655601 · results posted 8 June 2025

    According to the results reported on ClinicalTrials.gov, this trial studied a drug called BMX-001 in people newly diagnosed with high-grade brain tumours (a type of aggressive brain cancer). The trial had two parts: a Phase 1 part to find a suitable dose of BMX-001 when given alongside standard radiation therapy and a chemotherapy drug called temozolomide (TMZ), and a Phase 2 part to look at how long patients lived. In the Phase 1 part, 17 people were enrolled across four different dose levels. In the Phase 2 part, 80 people received BMX-001 plus radiation and TMZ, and another 80 people received radiation and TMZ without BMX-001. The reported data shows that in Phase 1, a single participant across all four dose groups experienced what is called a dose-limiting toxicity — meaning a side effect serious enough to potentially limit how much of the drug could be given. No formal maximum tolerated dose was reached, but a dose was selected for use in Phase 2. The median overall survival for Phase 1 participants — meaning the point in time by which half of the participants had died and half were still alive — was reported as 22.2 months. For Phase 2, the reported median overall survival was 32.2 months for the group receiving BMX-001 alongside standard treatment, and 27.6 months for the group receiving standard treatment alone. The reported data also includes scores from two thinking and memory tests carried out during Phase 1, with small changes in scores across the different dose groups; however, the numbers reported are change scores rather than full baseline results, so a complete picture of cognitive performance is not available from this data 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 ↗

  • NCT01288235 · results posted 3 June 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 100 children who received proton radiotherapy (a type of radiation treatment that uses proton particles rather than standard X-rays). All 100 participants completed the study. The trial was measuring several things over time: whether participants developed hormonal (endocrine) problems, how their thinking and learning abilities changed, whether their cancer came back or spread, and whether they experienced significant side effects — including hearing loss. The reported data shows that, looking at hormonal problems, an estimated 14.5% of participants had developed endocrine (hormone-related) dysfunction by three years after treatment, rising to an estimated 20.2% by five years. For thinking and learning abilities, the trial used a standardised children's intelligence test where a score of 100 represents the average for the general population. The reported data shows participants scored an average of 99.2 at one measurement point and 100.3 at another — both close to the general population average, though the data does not specify the exact timing of each measurement. Regarding disease control, the reported figures suggest an estimated 89.9% probability of the cancer not returning locally (near the original site) at three years, and 85.9% at five years; for distant spread (further from the original site), the estimated figures were 97.0% at three years and 95.0% at five years. The reported data also shows that an estimated 12.2% of participants experienced serious side effects (graded as severe or higher on a standard medical scale) by three years after treatment, increasing to 16.3% by five years. For hearing loss specifically, an estimated 12.5% of participants were reported to have experienced significant hearing loss at both the three-year and five-year marks — meaning no additional cases appeared to be recorded between those two time points, though further detail 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 ↗ · Linked publication on PubMed ↗

  • NCT02521051 · results posted 13 May 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02521051) looked at a combination of two medicines — alectinib and bevacizumab — in people with lung cancer that had spread to the brain. The trial had two stages: a Phase I stage to work out the right doses to use together, and a smaller Phase II stage to look further at those doses. In total, 11 people took part — 6 in the Phase I group and 5 in the Phase II group. No participants in either group were recorded as having left the study early. The reported data shows that, in the Phase I stage, the doses selected to carry forward were alectinib 600 mg and bevacizumab 15 mg/kg. In the Phase II stage, the trial was specifically tracking whether any participants experienced bleeding inside the brain (a known concern with bevacizumab), and the reported number of participants who had such an event was zero out of five. For secondary measures focused on brain tumour response, the reported data shows that in the Phase I group, approximately 67% of participants had their brain tumours shrink by a meaningful amount (called an "objective response"), and in the Phase II group this figure was 60%. All participants in both groups were reported to have had their disease either shrink or stay stable (a 100% "disease control rate" in each group). The reported time until brain disease worsened or death from brain disease (called "progression-free survival") was around 23.9 months in the Phase I group and around 7.2 months in the Phase II 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 ↗

  • NCT04006119 · results posted 18 April 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people with recurrent or progressive glioblastoma (an aggressive form of brain tumour that had come back or kept growing). All participants received a combination of three treatments: an injection directly into the tumour (Ad-RTS-hIL-12), a daily oral tablet (veledimex), and an intravenous drug called cemiplimab. The trial was measuring two main things: how often and how seriously participants experienced unwanted side effects, and how long participants lived overall. The study was closed earlier than planned, which the researchers noted limited how fully the results could be assessed. The reported data shows that of the 39 participants tracked for side effects, 28 experienced any treatment-related unwanted effects, and 32 experienced what are classed as serious unwanted effects. Five participants had unwanted effects that led to changes in their dose, and 8 had unwanted effects that led to stopping treatment altogether. The median overall survival — meaning the point at which half the participants had died and half were still alive — was reported as approximately 12.09 months from the first dose. For the secondary measures, the reported data shows that 8 participants had died by the 6-month mark, 19 by 12 months, and 24 by 18 months. The mean (average) time until disease progression or last scan was reported as 89 days. Three participants showed a recorded tumour response (meaning some measurable reduction in tumour size) at any point during the study, and 5 participants showed what is called pseudoprogression — where scans can look worse before potentially stabilising — at some point while on the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01604512 · results posted 8 April 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 148 people who had a brain tumour, and 141 of them completed the study. The trial was looking at two types of brain scans — a PET/CT scan and an MRI perfusion scan (a special MRI that measures blood flow in the brain) — to see whether these scans could help tell apart two things that can look similar on standard imaging after radiation treatment: damage caused by the radiation itself, versus the tumour growing back. The reported data shows that, of the 148 participants who started the study, 53 received the PET/CT scan and 95 received the MRI perfusion scan. The trial was set up to assess how useful each of these imaging approaches might be in guiding diagnosis and treatment planning in this situation, though no further breakdown of imaging findings or outcomes was included in the submitted results data. For the secondary measure, the reported data shows that the middle-point time (known as the "median" — meaning half the participants fell above this figure and half below) between finishing radiation therapy and when a suspicious or uncertain lesion was first detected on a scan was 9 months. No additional secondary outcome data beyond this figure 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 ↗

  • NCT03642067 · results posted 28 January 2025

    According to the results reported on ClinicalTrials.gov, a total of 59 people with colorectal cancer took part in this trial. They were divided into three groups based on certain biological markers (proteins) found in their tumour tissue: 12 people in Cohort A (who had both markers present), 15 in Cohort B (who had neither marker present), and 32 in Cohort C (who did not require marker testing). The trial was primarily measuring how many participants had their tumours noticeably shrink or disappear in response to the study treatment, a measure known as the "objective response rate." The reported data shows that very few participants across all three groups had their tumours shrink to the level required to count as a response. In Cohort A (12 participants), zero people met that threshold. In Cohort B (15 participants), one person did. In Cohort C (32 participants), two people did. The trial also tracked how many participants had to stop taking the study drug due to side effects thought to be related to it. According to the results reported on ClinicalTrials.gov, zero participants in each of the three groups stopped treatment for that reason. The reported data shows that 58 out of 59 participants completed the study, with one person in Cohort C not completing it — though the reason for this was not reported in the data provided. No further detail on other outcomes was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03276676 · results posted 27 December 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03276676) enrolled a total of 10 participants, split into two groups: 4 people in Arm A and 6 people in Arm B. The trial was looking at brain tumour imaging, specifically whether two special PET scan tracers — [18F]FLT and [18F]Fluciclovine — could detect changes in tumour activity in the brain at different points during and after chemoradiotherapy (a combined chemotherapy and radiation treatment). The scans were taken before treatment, shortly after treatment finished, and again if the tumour appeared to change on an MRI scan within six months of completing chemoradiation. The reported data shows that the main outcome measure — counting how many patients in Arm A showed a greater than 25% reduction in how much of the tracers the brain took up — was only assessed in Arm A, as multiple scans over time were needed to calculate the change. Across the various individual measurements reported (covering different combinations of the two tracers and two ways of measuring uptake, called SUVmax and SUVmean), the numbers of participants showing that level of reduction were small, ranging from 0 to 2 out of the participants scanned at each time point. Of the 4 people who started in Arm A, only 2 completed the study, and the reported figures reflect this small group size. The reported data shows no secondary outcome measures were submitted alongside these results on ClinicalTrials.gov, so no further numerical findings are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03296696 · results posted 29 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03296696) tested a drug called AMG 596 in people with a type of brain tumour. A total of 30 people were enrolled across ten groups, each receiving a different dose of the drug — ranging from a very small 4.5 micrograms up to 6,000 micrograms — to help researchers understand how the body responded at each dose level. Almost all participants did not complete the full study period; only one person (in the 1,500 mcg group) was recorded as having completed the trial. The reported data shows that none of the participants in any dose group experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious harmful reaction severe enough to be considered a limit on how much of the drug could be given. However, the trial also tracked any unwanted medical events that occurred after starting treatment. Across the groups, nearly all participants who received the drug — 28 out of 29 who received the investigational product — had at least one such event recorded. The number judged to be related to the treatment ranged from 1 to 4 participants per dose group. For the blood-level measurements of AMG 596, the reported data shows that the average concentration of the drug in the blood tended to rise as the dose increased, from 0.733 ng/mL at the lowest dose up to 610 ng/mL at the highest. One measure of how the drug moved through the body over time (area under the concentration curve) was not reported, as the trial noted there were insufficient samples collected to calculate it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT04013672 · results posted 28 August 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 41 participants, all of whom were placed in Arm A — people with recurrent glioblastoma (a type of aggressive brain tumour) who had not previously received immunotherapy. Arm B, which was intended for people who had already tried a type of immunotherapy called anti-PD1 therapy, recorded zero participants enrolled. The trial was measuring how a combination of two treatments — Pembrolizumab (an immunotherapy drug) and SurVaxM (a vaccine-type treatment) — performed in this setting. Of the 41 people who started, 32 completed the study and 9 did not. The reported data shows that the primary outcome being tracked was "progression-free survival at 6 months" — meaning the percentage of participants whose disease had not visibly worsened at the 6-month mark. For Arm A, the reported figure was 34.5% of participants. No data was reported for Arm B, as no participants were enrolled in that group. For the secondary outcome, the trial recorded side-effect events using a standard medical grading system (which categorises events from mild, grades 1–2, through to more serious, grades 3–5). The reported data shows a range of event counts across different categories — for example, figures including 481, 107, 43, 6, 31, 508, 6, 25, 38, 67, 452, and 39 events were listed for Arm A — however, the data as submitted does not include labels clearly linking each number to a specific event category, so a full plain-English breakdown of those figures cannot be provided without risk of misrepresentation. 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 ↗

  • NCT01244737 · results posted 11 July 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 children in total across three groups: 16 with a new brain tumour diagnosis, 28 where doctors were concerned a brain tumour may have come back, and 6 whose brain tumour was being monitored during chemotherapy. The trial was measuring whether a specialised type of PET scan — using a radioactive tracer called FLT that is taken up by rapidly dividing cells — could reflect how actively the tumour cells were growing, as confirmed by laboratory analysis of tumour tissue removed during surgery. The reported data shows that in the newly diagnosed group, the average FLT scan uptake (a measure called SUV max, which reflects how much tracer collected in the tumour) was 1.57, while in the possible recurrence group it was 3.00. When tumour tissue from these same patients was examined under a microscope using a staining test called MIB immunostaining (which labels actively dividing cells), the reported average percentage of positively stained cells was 17.3% in the newly diagnosed group and 32.8% in the possible recurrence group. For the chemotherapy monitoring group, the reported FLT uptake was 0.85 before treatment and 0.47 after two cycles of chemotherapy. The secondary outcome looking at how the tracer spread through the body was listed in the data but no numerical results were reported for it. It is worth noting that not all participants who started the trial completed all stages — for example, only 8 participants in the new diagnosis group and 5 in the possible recurrence group reached full completion, meaning the numbers in the final analysis were quite small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04796935 · results posted 6 June 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people in the tactile imaging group (using a device called VerTouch) and 48 people in the control group (where the standard hand-feel method, called palpation, was used to locate the right spot on the back). The trial was looking at a procedure that involves inserting a needle into the spine — likely a spinal anaesthetic or similar — and was measuring how many times the needle needed to be moved or reinserted before the right location was reached. Both groups were made up of people undergoing this type of procedure, and the trial compared the device-guided approach against the standard touch-based approach. The reported data shows that, for the primary measure — the number of separate needle insertion attempts — the VerTouch group averaged 1.8 attempts and the control group averaged 2.2 attempts. For needle redirections (adjusting the needle's angle without fully withdrawing it), the VerTouch group averaged 4.5 and the control group averaged 5.8. When insertions and redirections were added together, the VerTouch group averaged 6.4 total needle movements compared to 8.0 in the control group. For participants who succeeded on the very first insertion without any reinsertion, the reported data shows 25 people in the VerTouch group and 25 in the control group achieved this. Success on the very first pass (no reinsertion and no redirection at all) was reported in 10 VerTouch participants and 9 control participants. The reported data also includes a measure of discomfort during the landmarking phase (finding the right spot before the needle is used), rated on a 1–10 scale where 1 means no pain. The VerTouch group averaged a score of 2.0 and the control group averaged 1.9. It is worth noting that the data as submitted includes what appear to be two sets of figures for each outcome measure, though the trial record does not clearly label these as separate time points or subgroups — this detail was not fully explained 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 ↗

  • NCT02014844 · results posted 29 May 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02014844) looked at a drug called aldoxorubicin in people with a type of brain tumour. A total of 28 participants took part — 21 received a lower dose (250 mg/m²) and 7 received a higher dose (350 mg/m²). The trial's main goal was to measure the "objective response rate," which means the proportion of participants whose tumours showed a clear, measurable shrinkage or disappearance according to standard imaging criteria. The reported data shows that in the lower-dose group of 21 participants, zero participants met the criteria for a meaningful tumour response. In the higher-dose group of 7 participants, one participant met those criteria. No other outcome measure results were included in the data submitted to ClinicalTrials.gov for this trial, so further details beyond these numbers cannot be reported here. It is worth noting that these are the numbers as submitted, and the trial involved a small number of participants overall. The reported data shows only what was measured and counted — it does not on its own tell us whether aldoxorubicin does or does not work for this condition. 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 ↗

  • NCT01494662 · results posted 22 May 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 140 people in total, divided into seven groups (called cohorts). Each cohort was made up of people with cancer that had spread to the brain (known as brain metastases), and the different groups reflected different cancer types or treatment situations. The trial was measuring how often tumours in the brain shrank or disappeared in response to treatment, as well as how long participants went without their disease getting worse, and how long they survived overall. The reported data shows that the main measurement — the proportion of participants whose brain tumours shrank or disappeared — varied considerably across the groups. In Cohort 1, around 7.5% of participants met this threshold using one set of measuring rules, and 10% met it under a slightly different set of rules. In Cohort 3A, 48.6% of participants met the threshold, while in Cohort 3B it was 33.3%. For Cohorts 4A, 4B, and 4C (measured using a different standard called RANO-BM criteria), the figures were 33.3%, 35.3%, and 28.6% respectively. For the secondary measures, the reported data shows that the time participants went without their disease worsening (progression-free survival) ranged from about 1.9 months in Cohort 1 up to about 5.5 months in Cohort 3A. Overall survival — the time from joining the trial until death — ranged from 8.7 months in Cohort 1 to 30.16 months in Cohort 4A; the figure for Cohort 2 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 ↗

  • NCT03581292 · results posted 23 April 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people in total, split across two groups (called strata) based on their condition. Stratum 1 had 24 participants and Stratum 2 had 14. The trial was measuring how long people went without their disease getting worse or experiencing other serious events (called "event-free survival"), as well as how many people's tumours shrank during treatment and how many people were still alive at two years. The reported data shows that for the primary measure — event-free survival, expressed as a probability where 1.0 would mean all participants remained event-free — Stratum 1 recorded a probability of 0.99 (roughly 99%) and Stratum 2 recorded 0.96 (roughly 96%). For the secondary measure of tumour shrinkage (meaning tumours that completely disappeared or shrank by at least half), the reported data shows this occurred in approximately 9% of Stratum 1 participants and 14% of Stratum 2 participants who had measurable disease. For two-year overall survival — the proportion of participants still alive at two years — the reported figures were notably different between the two groups: 0.27 (about 27%) for Stratum 1 and 0.85 (about 85%) for Stratum 2. It is worth noting that 13 people in Stratum 1 and 5 in Stratum 2 did not complete the study, which may affect how these numbers are interpreted. The biomarker analysis results were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01854554 · results posted 2 January 2024

    According to the results reported on ClinicalTrials.gov, this trial compared two types of radiation treatment for brain tumours: standard intensity modulated radiotherapy (IMRT) and a newer form called intensity modulated proton radiotherapy (IMPT). A total of 90 people took part — 48 in the IMRT group and 42 in the IMPT group. The main thing the trial was measuring was how long it took for participants to show a meaningful decline in thinking and memory skills (called "cognitive failure"), based on a set of six standardised tests covering memory, attention, and verbal skills. The reported data shows that, on average, participants in the IMRT group took 7.7 months before showing a measurable decline in cognitive test scores, compared to 4.9 months in the IMPT group. For overall survival — how long participants lived from the start of the trial — the reported figures were 21.2 months for the IMRT group and 24.5 months for the IMPT group. The reported data also shows that the time before the disease progressed or worsened (called progression-free survival) was 8.9 months for the IMRT group and 6.6 months for the IMPT group. Regarding side effects, the trial tracked unwanted health events by severity level. The numbers of participants who experienced moderate side effects (Grade 2), severe side effects (Grade 3), and life-threatening side effects (Grade 4) were reported, but the data as submitted does not clearly separate which grade corresponds to which count, so those specific breakdowns cannot be described with certainty 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 ↗

  • NCT02323880 · results posted 2 January 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02323880) tested a drug called selinexor in children and young people with certain brain tumours (high-grade gliomas) and other solid tumours. A total of 59 participants were enrolled across eight different dosing groups, which varied by how much of the drug was given and how often (daily or weekly). The trial was organised into different parts — Part A (finding the right dose), Part B (a broader treatment group), and Part PK (focused on how the body processes the drug). Notably, the reported data shows that zero participants across all groups completed the study as defined by the trial protocol, with all participants recorded under "not completed." The reported data shows that three main things were measured as primary outcomes. First, the number of participants who experienced a "dose-limiting toxicity" — meaning a side effect serious enough to prevent the dose being increased — ranged from 0 to 4 participants depending on the dosing group. Second, the number of participants who experienced any adverse events (unwanted reactions) at least possibly linked to selinexor was high across groups, ranging from 6 to 12 out of the participants in each group. Third, the trial measured how much of the drug was present in the bloodstream over time; the reported median figures ranged from roughly 2,600 to 7,100 units (h·ng/mL) across the different groups. For the secondary outcomes, the reported data shows that no participants in any group achieved a measurable shrinkage of their tumour (either a partial or complete response) according to standard imaging criteria. Researchers also measured changes in a biological marker (XPO1 mRNA) in participants' blood before and after treatment; the reported median ratios of this marker after treatment compared to before ranged from approximately 1.7 to 7.9 across the different groups, suggesting the marker did change, though the trial data does not indicate what this means clinically. 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 ↗

  • NCT02078648 · results posted 6 December 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02078648) enrolled 74 adults in total — 46 people in a group receiving a treatment called SL-701 combined with GM-CSF and Imiquimod, and 28 people in a group receiving SL-701 combined with Poly-ICLC and Bevacizumab. The trial was measuring a number of things, including whether certain serious side effects (called "regimen-limiting toxicities") occurred, whether any unexpected deaths occurred that were linked to the study drug, how many participants were still alive at 12 months, and how tumours responded to treatment over time. No participants were recorded as having formally "completed" the study, which the reported data indicates was the case for all 74 enrolled. The reported data shows that, across both groups, zero participants experienced the pre-defined serious side effects being monitored, and zero participants experienced a sudden or unexpected death considered related to the study drug. Regarding survival at 12 months, 20 out of 46 participants in the first group and 14 out of 28 in the second group were reported as alive at that point. For tumour response, 2.2% of participants in the first group and 14.3% in the second group had their tumour shrink or disappear based on scan measurements. The reported data shows that 21.7% in the first group and 53.6% in the second group had their disease recorded as either shrinking or staying stable. For how long that response lasted, the data was not reported for the first group, while the second group showed a figure of 8.8 months on average. 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 ↗

  • NCT01128218 · results posted 30 November 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 33 people in total across two phases. In Phase 1, 19 people were divided into five groups, each receiving a different dose of a substance called 5-ALA (ranging from 10 mg per kilogram of body weight up to 50 mg/kg), taken by mouth before brain surgery for malignant glioma (a type of brain tumour). The goal was to find a dose that did not cause serious side effects, and then to test how well that dose helped surgeons visually identify tumour tissue during surgery using a special blue light that makes certain tissue glow. A further 14 people took part in Phase 2, all receiving the 40 mg/kg dose identified in Phase 1. All 33 participants who started the trial completed it. The reported data shows that in Phase 1, no "dose-limiting toxicities" (meaning serious side effects severe enough to stop increasing the dose) were recorded at any of the five dose levels tested. In Phase 2, tissue samples were taken from areas that glowed under blue light and areas that did not, and a specialist examined each sample to confirm whether tumour was actually present. The reported data shows: 14 samples came from glowing areas that did contain tumour (true positives), 6 samples came from non-glowing areas that did contain tumour (false negatives), 8 samples came from non-glowing areas with no tumour (true negatives), and 0 samples came from glowing areas with no tumour (false positives). From those biopsy counts, the trial calculated four summary figures for Phase 2: sensitivity (how often the glow correctly identified tumour tissue) was reported as approximately 63.64%; specificity (how often the absence of glow correctly identified non-tumour tissue) was reported as 100%; positive predictive value (the chance that a glowing area was actually tumour) was reported as 100%; and negative predictive value (the chance that a non-glowing area was actually tumour-free) was reported as approximately 42.86%. These figures are based on a small number of participants, and the data for any additional outcome measures beyond those listed above was not reported 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 ↗ · Linked publication on PubMed ↗

  • NCT00588523 · results posted 27 October 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people who had been newly diagnosed with a type of brain tumour called anaplastic oligodendroglioma. Of those 60, 57 completed the study and 3 did not. The trial was looking at how long participants went without their disease getting worse after receiving a high-dose chemotherapy treatment that required support from their own stored blood stem cells (a process used to help the body recover after intensive chemotherapy). The reported data shows that the main thing being measured was "progression-free survival" — that is, the proportion of participants whose disease had not gotten worse by a certain point in time. According to the results reported on ClinicalTrials.gov, 85.7% of participants fell into this category, meaning their disease had not progressed at the time of reporting. The reported data also shows that all 60 participants were assessed for side effects and reactions to the treatment, though the specific details of what those side effects were and how many people experienced them were not reported in the structured results data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT03190967 · results posted 11 October 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03190967) was conducted in two stages. The first stage (Phase I) involved 12 people in total — 3 at the lowest drug dose, 3 at a middle dose, and 6 at the highest dose — and was designed to find the highest dose of the chemotherapy drug temozolomide (TMZ) that could be given alongside another drug called ado-trastuzumab (T-DM1) without causing too many serious side effects. The second stage (Phase II) was intended to compare T-DM1 alone against T-DM1 combined with TMZ in people with breast cancer that had spread to the brain, but the reported data shows that no numerical results were submitted for the Phase II portion of the trial. The reported data shows that in Phase I, the dose identified as the maximum tolerated level — meaning the highest dose where the number of participants experiencing a pre-defined serious reaction stayed within an acceptable limit — was 40 mg/m² of TMZ. When it came to serious side effects (graded as "severe" or "life-threatening" on a standard medical scale), the numbers reported across the three dose groups were generally low, though the highest-dose group (50 mg/m²) had more participants recorded with severe or life-threatening events compared to the lower-dose groups. No participants in any dose group were reported as having a "dose-limiting toxicity" — a pre-set threshold of serious reaction used to judge whether a dose is too high. For median survival (the point in time by which half the participants in each group had passed away), the reported figures were 37.8 months for the lowest-dose group, 48.4 months for the middle-dose group, and 38.5 months for the highest-dose group. These are descriptive numbers only from small groups, and the Phase II outcome data — including how long participants went without new brain lesions — 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 ↗

  • NCT00626990 · results posted 11 September 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 751 people across four groups, all of whom had been diagnosed with a type of brain tumour (low-grade glioma). The four groups received different combinations of radiotherapy (RT) and a chemotherapy drug called temozolomide (TMZ): radiotherapy alone, radiotherapy with temozolomide given at the same time, radiotherapy followed by temozolomide given afterwards, or radiotherapy with temozolomide given both at the same time and afterwards. The trial was primarily measuring how long participants lived after joining the study, and also tracked how long they lived before their disease got worse. The reported data shows that, when looking at overall survival (time from joining the study until death from any cause), participants who did not receive temozolomide at the same time as radiotherapy had a median survival of about 60 months, compared to about 67 months for those who did receive it concurrently. When comparing the adjuvant (after radiotherapy) temozolomide groups, those without adjuvant temozolomide had a median survival of around 47 months, while those who received adjuvant temozolomide had a median survival of around 82 months. For progression-free survival (time before the disease worsened or death), the reported figures were approximately 21 months without concurrent temozolomide versus 33 months with it, and about 19 months without adjuvant temozolomide versus approximately 43 months with it. Quality of life and neurological deterioration-free survival were also listed as outcomes, but no numerical results for these 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 ↗ · Linked publication on PubMed ↗

  • NCT04410367 · results posted 1 August 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 23 participants who received an injection of a radioactive imaging agent called 18F-fluciclovine and then had a PET scan (a type of body imaging). All 23 participants completed the study. The trial was measuring how well the PET scan could identify whether a brain lesion was a returning cancer (called a brain metastasis) compared to the result of a tissue biopsy, which was used as the reference standard. Three independent readers assessed each scan and rated the level of tracer uptake (how much of the imaging agent was absorbed by the lesion) as absent, mild, moderate, or marked. The reported data shows results for two key measures: **sensitivity** (the percentage of people whose scan correctly flagged a lesion as cancerous when the biopsy confirmed it was) and **specificity** (the percentage of people whose scan correctly showed no cancer when the biopsy confirmed there was none). These were calculated across different reading thresholds. For sensitivity, the reported figures ranged from 40% to 100% depending on the threshold used and which reader assessed the scan — at the lowest threshold (any uptake at all), sensitivity was reported as 100% by some readers, while at the strictest threshold (marked uptake only), it dropped as low as 40%. For specificity, the pattern was roughly the opposite — at the loosest threshold, specificity was reported as low as 0%, while at the strictest threshold, it reached as high as 100%. The reported data also shows results using a numerical measurement method (SUV), where sensitivity ranged from 0% to 80% and specificity from 84.6% to 100% depending on the approach. For the dynamic uptake patterns assessed by the three readers, sensitivity ranged from 0% to 100% and specificity from 0% to 100% across the different pattern categories. Regarding side effects, the reported data shows that 1 out of 23 participants experienced a treatment-related adverse event (an unwanted effect) in the day following the injection, though the specific nature of that event was not described 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 ↗

  • NCT04631029 · results posted 27 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04631029) enrolled 3 participants, all of whom completed the study. There was only one dosing group, referred to as Dose Level 1. The trial was testing a combination of four medicines — entinostat, atezolizumab, carboplatin, and etoposide — and was primarily looking at safety signals early in development, including how many participants experienced serious side effects and whether the dose caused what are called "dose limiting toxicities" (side effects severe enough to prevent continuing or increasing the dose). The reported data shows that, for dose limiting toxicities, the measurements recorded were 1 and 2 participants across the reported data points (the structured data contains two separate figures, though the full breakdown of timing or categories was not further detailed in the submitted results). For serious side effects graded as severe or life-threatening (Grade 3 or 4), the reported figures were 3 and 2 participants respectively across the reported data points. Regarding how many participants received 3 or more treatment cycles, the reported data shows figures of 0 and 3. For the secondary outcome — the proportion of participants who were alive and whose disease had not progressed (called progression-free survival) — the reported figures were 0, 1, and 2 participants across the recorded time points. No further detail on specific timeframes for these figures was provided in the submitted data. It is worth noting that with only 3 participants, this was a very early-stage trial focused on exploring dosing and initial safety signals, not on drawing broad conclusions. The reported data shows only a small snapshot of results from a single dose level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02573324 · results posted 11 May 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 691 participants across two main groups: 341 people received a placebo combined with radiation therapy and a chemotherapy drug called temozolomide (TMZ), and 344 people received an experimental drug called depatuxizumab mafodotin combined with the same radiation and TMZ. A small separate group of 6 people took part in an open-label sub-study also receiving depatuxizumab mafodotin with radiation and TMZ. All participants had been diagnosed with a type of brain tumour called glioblastoma. The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked how long it took for the disease to get worse (called "progression-free survival"), as well as results broken down by certain tumour characteristics. The reported data shows that for the main measure — overall survival — the placebo group lived a median of 18.7 months from the time they joined the trial, while the depatuxizumab mafodotin group lived a median of 18.9 months. (A "median" here means the midpoint — half the people in that group lived longer than that figure, and half did not reach it.) For the secondary measures, in a subgroup whose tumours had a particular genetic feature called "MGMT unmethylated," the reported median survival was 16.2 months in the placebo group and 16.1 months in the depatuxizumab mafodotin group. For the "MGMT methylated" subgroup, the placebo group's median survival figure was listed as "not available" (meaning enough events had not yet occurred to calculate it), while the depatuxizumab mafodotin group's figure was reported as 25.4 months. In a further subgroup defined by a different tumour feature (EGFRvIII mutation), median survival was reported as 18.2 months for placebo and 19.8 months for the experimental drug. The reported data also shows that for progression-free survival — the time before the disease got worse — the placebo group had a median of 6.3 months, compared with 8.0 months for the depatuxizumab mafodotin group. In the EGFRvIII-mutated subgroup specifically, this figure was 5.9 months for placebo and 8.3 months for the experimental drug. No participants were recorded as having "completed" the trial in the formal sense, as all participants either passed away or were counted as not completing for other reasons during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01096368 · results posted 2 March 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 479 children with a type of brain tumour called ependymoma. Participants were placed into different groups depending on how much of their tumour could be removed by surgery and whether they were assigned by chance (randomised) to a particular treatment. The main question the trial was measuring was whether children who received radiation therapy followed by maintenance chemotherapy (ongoing drug treatment after the main treatment) did differently — in terms of how long they went without their disease getting worse, and how long they survived overall — compared with children who received radiation therapy alone with no further treatment. The reported data shows that, for the two main randomly assigned groups, the percentage of children estimated to be free from disease progression or death at the time of analysis was 69.2% in the radiation-plus-maintenance-chemotherapy group and 63.7% in the radiation-only group. For overall survival (the proportion still alive), the reported figures were 88.3% and 86.9% respectively. When the data was looked at separately for children whose tumour was fully removed at the first surgery, the reported event-free figures were 72.7% (chemotherapy group) versus 62.9% (radiation only). For children who initially had an incomplete removal but later achieved full or near-full removal, the reported figures were 41.7% (chemotherapy group) versus 67.5% (radiation only). The corresponding overall survival figures for these two subgroups were 90.7% vs 86.4%, and 69.2% vs 89.5%, respectively. It is important to note that these are estimated percentages based on a statistical method (called Kaplan-Meier, a way of tracking outcomes over time in a group) and reflect the data as submitted to the registry. The reported data shows differences between groups in these numbers, but this summary does not draw any conclusions about whether one approach is better or worse than another. 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 ↗

  • NCT03463525 · results posted 27 January 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03463525) enrolled 4 participants, and all 4 completed the study — none dropped out. The trial used a special type of brain scan called a PET scan to measure how much of a radioactively labelled version of the drug osimertinib entered the brain after being given to participants. It also took blood samples to track levels of osimertinib and one of its breakdown products (called a metabolite, AZ5104) in the bloodstream. The reported data shows that, for the brain measurements, the peak amount of the labelled drug reaching the brain (expressed as a percentage of the total dose given) was recorded at three separate time points, with values of approximately 1.47%, 1.62%, and 1.49%. A related brain measurement called the Standardised Uptake Value — a way of expressing how much of the drug concentrated in the brain relative to body size — was reported as roughly 1.01, 1.11, and 1.05 at those same points. The time it took for the drug to reach its highest level in the brain was reported as approximately 22, 36, and 37 minutes. The ratio of drug in the brain compared to drug in the blood (known as the brain-to-plasma partition coefficient) was reported as approximately 3.75, 3.96, and 4.66. For the blood measurements, the peak steady-state concentration of osimertinib in the blood was reported as 648.0 nanomoles per litre, and for the metabolite AZ5104 it was 76.53 nanomoles per litre. Both the drug and its metabolite reached their peak blood levels at around 4 hours. 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 ↗

  • NCT02337686 · results posted 11 January 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people who received a combination of pembrolizumab (an immunotherapy drug) and surgery. All participants were in a single treatment group, and 14 of the 15 people completed the study. The trial was primarily looking at how many participants were still alive and had not seen their disease get worse or spread at the 6-month mark. The reported data shows that all 15 participants were counted when measuring progression-free survival at 6 months (meaning they were all included in that assessment). For the secondary outcomes, 10 out of 15 participants experienced disease progression — that is, their disease got worse or spread at some point during the study. The reported median overall survival (the point at which half the participants had passed away and half were still alive) was 20 months. Three out of 15 participants showed a measurable response to treatment as assessed by brain scans, meaning their tumours either disappeared or shrank by at least 50%. Regarding reported side effects, the trial recorded 31 mild (grade 1) adverse events, 18 moderate (grade 2) adverse events, and 6 more significant (grade 3) adverse events. The reported data notes there were no grade 4 (severe) adverse events recorded. 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 ↗

  • NCT02017717 · results posted 29 June 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02017717) enrolled a total of 529 participants across several different treatment groups. The groups included people receiving various combinations of investigational treatments — referred to in the data as different "Arms" and "Cohorts." The trial was measuring a range of things: how often participants in the earlier cohorts (groups 1, 1b, 1c, and 1d) experienced unwanted health events (called adverse events) or abnormal results on liver and thyroid blood tests, and — for the largest group (Cohort 2, with 184 and 185 participants in two arms) — how long participants survived overall. The reported data shows that, across the earlier cohorts, 0% of participants stopped their treatment early due to a drug-related adverse event in all groups reported for that measure. The percentage of participants who experienced any adverse event (of the worst severity recorded) varied by group — ranging from 0% to around 30% depending on the treatment arm. Serious adverse events ranged from 0% in several groups to about 17% in one group. Abnormal liver test results were reported in 0% to about 23% of participants depending on the group and which liver marker was measured, and abnormal thyroid test results ranged from about 7% to 50% across groups. For Cohort 2 — the largest, randomised part of the trial — the reported median overall survival (that is, the point in time by which half the participants in each group had died) was approximately 9.77 months in one arm and 10.05 months in the other arm. 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 ↗

  • NCT02330562 · results posted 8 June 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02330562) enrolled a total of 121 participants across 11 groups, which were organised into four main parts. The trial was studying a drug called Marizomib, given alone or in combination with other treatments, in people with brain tumours. Different parts of the trial had different goals: Part 1 looked at finding an appropriate dose, Part 2 measured how often tumours showed a response on scans, Part 3 measured how long participants lived, and Part 4 explored a different way of delivering the drug. The reported data shows that in Part 2 (30 participants), the radiographic objective response rate — meaning the percentage of participants whose tumour showed a measurable reduction or disappearance on scans — was reported as 3.3%. For Part 3, the reported data shows that the median overall survival (that is, the midpoint of how long participants lived from their first dose) was 8.3 months for Part 3 Cohort 1 (31 participants) and 7.5 months for Part 3 Cohort 2 (10 participants). Notably, the reported data shows that zero participants were recorded as having "completed" the study across all groups, meaning all participants left the study before its scheduled end, for reasons not detailed in this summary. Regarding unwanted events, the reported data shows that across the various groups, all participants who started the study experienced at least one treatment-emergent adverse event (an unwanted health event that occurred after receiving the study drug). Serious adverse events were reported in a portion of participants in each group — for example, 14 out of 31 in Part 3 Cohort 1 and 10 out of 30 in Part 2. Dose-limiting toxicities (side effects serious enough to affect dosing) were reported in 1 participant each in Part 1 Cohort 1 and Part 4 Cohort 5. In Part 3, the reported data shows that all 31 participants in Cohort 1 and all 10 in Cohort 2 experienced dose-limiting adverse events as defined for that part of 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 ↗

  • NCT03150862 · results posted 31 May 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03150862) enrolled a total of 116 participants across eight different treatment groups. The trial tested a drug called pamiparib — either alone alongside radiation therapy, or combined with another medicine called temozolomide — in people with brain cancer. The study had two main phases: an early dose-finding phase (Phase 1b) to work out safe dosing, and a later expansion phase (Phase 2) to look at how tumours responded to treatment. The reported data shows that in the dose-finding phase, the number of participants who experienced what are called "dose-limiting toxicities" (that is, side effects serious enough to potentially limit how much of the drug could be given) varied by group: 0 out of 3 in the shortest pamiparib-plus-radiation group, 0 out of 8 in the next group, 2 out of 9 in the six-week pamiparib-plus-radiation group, 1 out of 9 in the group that also received temozolomide, 0 out of 9 in the lowest temozolomide dose group, and 3 out of 8 in the middle temozolomide dose group. All participants in the dose-finding phase experienced at least one treatment-emergent adverse event (meaning a medical event that appeared or worsened after starting treatment). Serious adverse events — those resulting in hospitalisation, being life-threatening, or similarly significant — were also recorded across all groups, ranging from 1 to 7 participants per group. For the Phase 2 results, the reported data shows that in the pamiparib-plus-radiation expansion group (40 participants), 65.6% had their disease recorded as controlled (meaning no worsening, or some shrinkage) at the end of treatment. In the temozolomide expansion group (30 participants), 10.7% were reported to have had their tumour shrink meaningfully. No participants across any group were recorded as having "completed" the study in the formal milestone sense, as noted 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 ↗

  • NCT02667587 · results posted 3 February 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02667587) enrolled 358 people in each of two groups — one group received radiotherapy and the chemotherapy drug temozolomide together with nivolumab (an immunotherapy drug), and the other received the same radiotherapy and chemotherapy but with a placebo (an inactive dummy treatment) instead. The trial was primarily measuring two things: how long participants went without their tumour growing or spreading (called progression-free survival), and how long participants survived overall (overall survival). The reported data shows that for progression-free survival — the time before the tumour grew or participants died — the nivolumab group had a reported median (middle value of all results) of around 10.6 months, compared with around 10.3 months in the placebo group, as assessed by an independent review panel. When assessed by the treating doctors instead, those figures were approximately 14.1 months and 15.2 months respectively. For overall survival, the reported data shows two sets of figures, likely reflecting different sub-groups of participants: in one analysis the nivolumab group had a median of around 28.9 months versus 32.1 months in the placebo group, and in another analysis approximately 31.3 months versus 33.0 months. For the secondary measures, the reported data shows that at 12 months, approximately 82.7% of the nivolumab group and 87.7% of the placebo group were still alive; at 24 months, those figures were approximately 55.9% and 63.3% 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 ↗

  • NCT01677741 · results posted 24 November 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 85 children and young people in total across two parts. Part 1 was a dose-escalation phase, meaning researchers started with a lower dose of the drug dabrafenib and gradually increased it to find an appropriate dose to carry forward. It included 27 participants split across four dose levels (3, 3.75, 4.5, and 5.25 milligrams per kilogram of body weight). Part 2 then tested dabrafenib in 58 participants grouped by tumour type: low-grade brain tumours (17 participants), high-grade brain tumours (28 participants), a condition called Langerhans Cell Histiocytosis (11 participants), and a mixed group of other tumour types (2 participants). The trial was primarily measuring how the drug moved through the body (its levels in the blood over time) and tracking any unwanted medical events (called adverse events) that occurred during treatment. The reported data shows that in Part 1, one participant in the highest dose group (5.25 mg/kg) experienced a dose-limiting adverse event — meaning an unwanted medical event serious enough to potentially limit how much of the drug could be given. No dose-limiting events were recorded in the three lower dose groups. Regarding blood levels of dabrafenib, the reported peak concentration (the highest amount of drug measured in the blood) ranged from around 1,250 to 1,900 nanograms per millilitre across the Part 1 dose groups, and from around 1,340 to 1,550 nanograms per millilitre in the Part 2 groups who received the carried-forward doses. The pre-dose trough level (the lowest amount of drug in the blood, just before the next dose) ranged from approximately 11 to 50.7 nanograms per millilitre across the different groups. Several other planned blood-level measurements — including a full picture of how long the drug stayed in the body — were not reported in the submitted data. The reported data shows that none of the 85 participants were recorded as having formally "completed" the study under the trial's own definitions, with all participants listed under "not completed." No data was reported for several secondary outcome measures, including the detailed breakdown of blood levels of dabrafenib's breakdown products (metabolites). 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 ↗

  • NCT01861717 · results posted 30 September 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01861717) enrolled 4 participants in a single group who received Somatuline Depot injections under the skin. The trial was looking at whether a 12-week course of this medication given before surgery, followed by a type of nasal surgery to remove a pituitary tumour, could lead to remission of a condition called acromegaly — a hormonal disorder caused by too much growth hormone. Of the 4 people who started, 2 completed the trial and 2 did not finish. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures. This includes the primary outcome — whether participants achieved remission of acromegaly based on hormone level tests — as well as all secondary outcomes, which were intended to measure changes in heart function, blood pressure, breathing, and quality of life. A longer-term outcome looking at remission status one year after surgery was also listed but similarly has no numbers reported. Because no measurement data was submitted for any outcome in this trial, it is not possible to describe what the results showed in numerical terms. The very small number of participants (4 in total) and the fact that only 2 completed the study may be relevant context, but no further explanation for the missing data is provided in the submitted record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02915744 · results posted 27 August 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 178 people with breast cancer that had spread to the brain. Participants were randomly assigned to receive either an investigational drug called NKTR-102 (92 people) or a treatment chosen by their doctor from existing options, referred to as Treatment of Physician's Choice, or TPC (86 people). The trial's main goal was to compare how long patients in each group lived overall, and it also measured how long it took for cancer to progress and how tumours responded to treatment. The reported data shows that for the primary measure — overall survival, meaning the time from entering the trial until death from any cause — the NKTR-102 group had a reported median of 7.8 months, compared with 7.5 months in the TPC group. (Median means half the participants in that group lived longer than this figure and half did not reach it.) For progression-free survival outside the brain — how long before the cancer outside the brain worsened — the reported medians were 2.8 months for NKTR-102 and 1.9 months for TPC. For progression in brain metastases specifically, the reported medians were 3.9 months versus 3.3 months. For overall progression (brain and body combined), the figures were 2.1 months versus 1.9 months. Regarding tumour response, 4 participants in the NKTR-102 group and 2 in the TPC group had a complete response (all measurable tumours disappeared), while 16 and 5 respectively had a partial response (tumours shrank by at least 30%). The clinical benefit rate — counting those with a complete response, partial response, or stable disease lasting at least four months — was 23 participants in the NKTR-102 group and 11 in the TPC 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 ↗

  • NCT01110876 · results posted 25 August 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 18 people in total across two groups. Thirteen participants took part in Phase I, which aimed to find the highest dose of a drug called vorinostat that could be given alongside two other drugs — erlotinib and temozolomide — without causing unacceptable side effects (known as "dose-limiting toxicity"). A further five participants took part in Phase II Part A, which was intended to compare different drug combinations in people with a brain tumour called recurrent glioblastoma (GBM) that had come back after earlier treatment. All participants in both groups completed their part of the study. The reported data shows that, in Phase I, the maximum tolerated dose — that is, the highest dose considered acceptable based on the side-effect monitoring process used — was identified as 200 mg of vorinostat when combined with erlotinib and temozolomide. For the secondary outcome — progression-free survival, which measures the length of time participants went without their disease getting worse — the reported data shows no numerical results were submitted to ClinicalTrials.gov for this measure. It is not possible to describe what was found for this outcome, as the 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 ↗

  • NCT02564198 · results posted 17 August 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02564198) looked at the cancer drug ramucirumab given to a total of 29 people across three groups: 8 people received a lower dose (8 mg/kg) in Part A of the trial, 15 people received a higher dose (12 mg/kg) also in Part A, and 6 people received the higher dose (12 mg/kg) in Part B. The trial was primarily measuring whether the drug caused serious side effects at each dose level (called "dose-limiting toxicities"), how the drug moved through the body (its concentration in the blood over time), and whether the body developed antibodies against the drug. Secondary measurements included whether participants' tumours shrank, stayed stable, or grew. The reported data shows that in Part A, one participant out of 8 in the lower-dose group and one participant out of 15 in the higher-dose group experienced a dose-limiting toxicity (a serious side effect potentially linked to the drug). For the blood concentration measurements, the minimum levels of the drug detected in the blood were reported as 30.0 and 53.6 micrograms per millilitre (µg/mL — a standard unit for measuring how much of a substance is in the blood) for the lower-dose group at two time points, and 48.3 and 80.2 µg/mL for the higher-dose group. No participants in any of the three groups developed antibodies against the drug. When it came to tumour response, the reported data shows that none of the participants across any group had their tumour shrink enough to count as a meaningful response (0% overall response rate). However, some participants' disease did not progress — the proportion whose disease was considered "controlled" (tumour shrank, responded, or stayed stable) was reported as 62.5% in the lower-dose group, 40.0% in the higher-dose Part A group, and 33.3% in the Part B group. The duration of response 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 ↗

  • NCT02765165 · results posted 23 July 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total across seven groups. Participants were divided into two main parts (Part 1a and Part 1b), each testing different doses of the study treatment. The trial was primarily trying to find the highest dose that could be given while keeping a particular type of side effect — called a "dose-limiting toxicity," meaning a side effect serious enough to prevent giving more — within an acceptable range. Secondary goals included tracking how long participants went without their disease getting worse, how many were still alive five years after starting treatment, and how many saw their disease shrink or disappear. The reported data shows that for both the primary outcome measures — the maximum tolerated dose in Part 1a and Part 1b — the recorded value was listed as "NA" (not available), meaning no specific dose figure was reported to ClinicalTrials.gov. The reported data also shows that none of the secondary outcome measures — including progression-free survival at six months, overall survival at five years, median time without disease progression, and the rate of disease shrinking or disappearing — had any numerical results submitted to ClinicalTrials.gov. Additionally, the data shows that zero participants were recorded as having "completed" either the treatment period or the follow-up period across all seven groups, though the reasons for this were not detailed in the submitted data. Because key figures were not reported for the primary or secondary outcomes, it is not possible to describe what the trial found about the dose or about participants' disease outcomes — that information was simply not included in the data 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 ↗

  • NCT02260531 · results posted 18 May 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people with breast cancer that had spread to the brain (known as brain metastases). Participants were divided into three groups based on the type of breast cancer they had: 21 people in Cohort 1 had HER2-positive cancer and received two drugs (cabozantinib and trastuzumab); 7 people in Cohort 2 had hormone receptor-positive cancer (ER+ and/or PR+) and received cabozantinib alone; and 8 people in Cohort 3 had triple-negative cancer (ER-, PR-, and HER2-negative) and also received cabozantinib alone. The trial's main focus was measuring how many participants saw their brain tumours shrink or disappear during treatment. The reported data shows that for the primary measure — the proportion of participants whose brain tumours shrank significantly or disappeared — 5% of Cohort 1 (roughly 1 out of 21 people), 14% of Cohort 2 (roughly 1 out of 7), and 0% of Cohort 3 met that threshold. A second way of measuring brain tumour response using volume (size in 3D) showed 5% in Cohort 1 and 0% in both other cohorts. For tumours outside the brain, 0% across all three groups met the response threshold. The reported data shows that the median time before the disease progressed or a participant died was 4.1 months in Cohort 1, 0.8 months in Cohort 2, and 2.4 months in Cohort 3. The 12-week "clinical benefit rate" — meaning the percentage of participants whose disease had not clearly worsened by 12 weeks — was reported as 43% in Cohort 1, 14% in Cohort 2, and 13% in Cohort 3. Data for the first site of progression (brain versus elsewhere) 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 ↗

  • NCT03419403 · results posted 14 April 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03419403) enrolled 40 people in total across four groups. Three groups received the cancer drug depatuxizumab mafodotin alongside different combinations of eye-protection strategies: "Standard Steroids" (14 people), "Standard Steroids plus a vasoconstrictor eye drop and cold compress" (12 people), and "Enhanced Steroids plus a vasoconstrictor eye drop and cold compress" (12 people). A small fourth group of 2 people received no eye-protection treatment. The trial was measuring whether different approaches to managing eye side effects — such as drops, compresses, and steroid medicines — could prevent those side effects from becoming serious enough to require a change in how they were managed. It is worth noting that very few participants completed the study: only 2, 3, and 0 in the first three groups respectively, with none completing in the fourth group. The reported data shows that for the primary outcome — the percentage of participants whose eye side effects became poorly controlled and needed a change in management — the figures were 50% in the Standard Steroids group, 27.3% in the Standard Steroids plus vasoconstrictor and cold compress group, and 41.7% in the Enhanced Steroids plus vasoconstrictor and cold compress group. For a secondary measure of vision change (using a scale called LogMAR, where higher numbers mean greater change from normal vision), the reported average maximum changes from each person's starting point were 0.353, 0.402, and 0.272 across the three groups respectively. Regarding dose changes to the cancer drug caused by eye side effects, 2, 3, and 2 participants in each group respectively had their dose modified. The total average amount of the cancer drug received was 8.5, 10.5, and 7.0 mg/kg across the three groups. The reported data also shows results for how long it took before some participants needed a special protective contact lens: this was not applicable for the Standard Steroids group, while the average time was around 3.6 months and 2.1 months for the other two groups. The data for the untreated fourth group was not reported for most outcome measures. Given the very small numbers of participants and the low completion rates, these figures should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02630030 · results posted 26 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, and all 3 completed the study. The trial involved a drug called ixazomib, and it was primarily measuring how much of the drug reached tumour tissue after it was taken. The trial also tracked any unwanted reactions participants experienced during the period from when they took the drug through to their surgery and wound healing. The reported data shows that ixazomib was detected in tumour tissue samples across all participants. In one set of tissue samples, the measured concentrations were 7.88, 2.03, 4.17, 2.70, and 3.25 nanograms per gram of tissue (a nanogram is an extremely tiny unit of weight). In a second set of tissue samples from the same group, the concentrations reported were 21.8, 18.0, and 36.2 nanograms per gram. These figures represent how much of the drug was found in the tumour at the time of testing. On the safety tracking outcome, the reported data shows that all 3 participants were assessed for unwanted reactions. For the secondary outcome — which looked at treatment-related unwanted reactions using a standard medical grading scale — the reported data notes that all 3 participants were included in this assessment, and the entry on ClinicalTrials.gov states there were no clinically relevant adverse events reported as a result of ixazomib administration. It is worth noting that with only 3 participants, this was a very small study, and the data was not reported in a way that allows for 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 ↗ · Linked publication on PubMed ↗

  • NCT00905060 · results posted 24 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total, all of whom received a treatment called HSPPC-96 (a protein peptide-complex). Of those 70, 46 went on to the vaccination treatment stage and all 46 completed it. The remaining 24 did not progress to the vaccination stage. The trial was measuring how long participants lived after surgery, how long they went without their disease getting worse, how many experienced side effects linked to the treatment, and levels of a particular protein marker (called PD-L1) in certain blood cells. The reported data shows that the median overall survival — meaning the point at which half the participants had passed away and half were still alive, measured from the time of surgery — was 23.8 months. The median time before the disease showed signs of getting worse (called progression-free survival) was reported as 18 months. When it came to side effects, the reported data shows that 34 out of the 46 participants who received the vaccination experienced at least one side effect considered to be related to the treatment. Regarding the blood marker measurement, the reported median level of PD-L1 positivity in circulating myeloid cells (a type of immune cell in the blood) was 54.5%. It is worth noting that this trial had only one group — everyone received the same treatment — so there was no comparison group included in the reported 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 ↗

  • NCT02617589 · results posted 3 February 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 560 adults with a type of brain tumour, with 280 randomly assigned to receive nivolumab (an immunotherapy drug) combined with radiation therapy, and 280 assigned to receive temozolomide (a chemotherapy drug) combined with radiation therapy. The trial's main goal was to measure overall survival — that is, how long participants lived after joining the study. The reported data shows that, for the primary measure of overall survival, the median time (the point at which half the participants had died and half were still alive) was approximately 13.4 months in the nivolumab plus radiation group, compared with approximately 14.9 months in the temozolomide plus radiation group. For a secondary measure — how long participants lived without their disease getting worse (called progression-free survival) — the reported median was about 6.0 months in the nivolumab group and 6.2 months in the temozolomide group. The reported data also shows that at the two-year mark, approximately 10.6% of participants in the nivolumab group and 21.2% in the temozolomide group were estimated to still be alive. For two additional secondary measures looking at outcomes specifically in participants whose tumours had a high number of genetic changes (known as "tumour mutational burden high"), no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02614794 · results posted 28 September 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02614794) enrolled 612 participants in total — 410 received a combination of tucatinib, capecitabine, and trastuzumab (referred to here as the active treatment group), while 202 received a placebo together with capecitabine and trastuzumab (the comparison group). The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), how long participants lived overall, and what proportion of participants' tumours shrank to a meaningful degree (called "objective response rate"). A subgroup of participants who had cancer that had spread to the brain at the start of the trial was also looked at separately. The reported data shows that, for the main measure — how long until the disease progressed — the active treatment group had a reported median of 7.8 months, compared with 5.6 months in the comparison group. (A "median" means the middle value: half the participants in that group reached that point sooner, and half took longer.) For participants who already had cancer in the brain at the start, the reported medians were 7.6 months versus 5.4 months. The reported data shows that for overall survival — how long participants lived from the start of the trial — the median was 21.9 months in the active treatment group and 17.4 months in the comparison group. Regarding tumour shrinkage, approximately 40.7% of participants in the active treatment group had a confirmed meaningful reduction in tumour size, compared with 23.4% in the comparison group, based on independent review. Notably, the data shows zero participants recorded as having "completed" the study, which likely reflects how trial completion was defined by the sponsor rather than meaning no one finished treatment — however, the data as submitted does not explain this further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01915303 · results posted 18 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 68 participants, all in a single group, to study a treatment approach for a condition involving too much of a hormone called cortisol in the body (measured through urine). The trial had two phases: a core phase and an extension phase. Of the 68 who started the core phase, 52 finished it and 16 did not. Of the 29 who went on to the extension phase, 12 completed it and 17 did not. The trial was primarily measuring how many participants reached a urine cortisol level within the normal range by week 35. The reported data shows that by week 35 — the main measurement point — 50% of participants had their urine cortisol level at or below the upper limit of normal. Looking at how that figure changed over time across scheduled check-ins, the proportion of participants reaching that normal-range target rose from about 4% at the earliest visit to as high as 100% at the final recorded visit in the extension phase, though the number of people still in the trial became smaller over time. A separate measure tracked participants who either reached the normal range or had their cortisol level drop by at least half from where it started; that figure also rose across visits, reaching 100% at some later time points. The reported data also shows that the average urine cortisol level across the group fell from around 502 units at the start to lower levels at later visits, with figures varying across check-ins. The average length of time participants maintained a controlled or partially controlled response was reported as approximately 13 weeks for one definition and 22 weeks for another. The reported data also includes measurements of a related hormone in the blood (ACTH), which appeared to fluctuate across visits in a relatively narrow range, though the clinical meaning of those numbers is not described here. It is worth noting that participant numbers decreased as the trial progressed, which can affect how the later percentages should be interpreted — this was not addressed 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 ↗

  • NCT00402116 · results posted 6 August 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called enzastaurin, given alongside standard brain tumour treatment (radiation and another medicine called temozolomide). The trial had two stages: a smaller Phase 1 stage to find a safe starting dose, and a larger Phase 2 stage. In total, 72 people took part — 6 in the lower-dose group (250 mg), 6 in the higher-dose group (500 mg), and 60 in the Phase 2 stage. Of those, only 8 people completed the study in full (3 from the first group and 5 from Phase 2), while the remaining participants did not complete it. The reported data shows that in Phase 1, the dose identified as the maximum tolerated dose — meaning the highest dose the researchers tested without too many serious side effects — was 250 mg per day. When looking at overall survival (the time from diagnosis to death from any cause) across participants who received the 250 mg dose in both phases combined, the reported median figure was 18.3 months. Regarding unwanted side effects (called adverse events), the reported data shows that in Phase 1, no participants in the 250 mg group and 1 participant in the 500 mg group had a recorded adverse event in this summary. In Phase 2, 22 out of 60 participants were reported as having adverse events. The trial also measured a biological marker called pS6 protein to see if it was linked to outcomes; the reported figures (called hazard ratios, which compare relative outcomes between groups) were 1.70 and 1.69 — a number above 1 suggesting a worse outcome for those with higher marker scores — though the data as submitted does not provide full detail on response rates (tumour shrinkage measurements), as 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 ↗

  • NCT01259869 · results posted 22 May 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people, all of whom received a treatment called PX-866. Thirty-three participants completed the study, and one did not. The trial was measuring what is called the "objective response rate" — that is, how many participants showed a reduction in the size of their brain tumour based on scans (either CT or MRI). The reported data shows that out of 34 participants, 1 person showed a measurable reduction in tumour size on their brain scans. No other outcome measures, such as secondary endpoints, appear to have been submitted in the structured results data on ClinicalTrials.gov, so no further figures can 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 ↗

  • NCT01763606 · results posted 15 May 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in a group receiving enoxaparin (a blood-thinning injection) and 10 in a group receiving aspirin (a blood-thinning tablet). All 20 participants completed the study. The trial was primarily looking at two things: whether it was practical to recruit patients (called a "feasibility" measure), and at a number of serious health events that were tracked across both groups. A secondary aim was to count how many people in each group experienced further strokes or other blood-clot-related events during the study period. The reported data shows that of all the patients who were considered eligible to join the trial, 41% actually enrolled. On the safety tracking, 1 participant in the enoxaparin group had a bleed inside the skull (intracranial haemorrhage), compared with 0 in the aspirin group. Symptomatic intracranial haemorrhage (a bleed inside the skull causing noticeable symptoms) was reported in 0 enoxaparin participants and 3 aspirin participants. Major bleeding (serious bleeding elsewhere in the body) occurred in 1 enoxaparin participant and 0 aspirin participants. Deaths during the study were reported as 8 in the enoxaparin group and 7 in the aspirin group. For the secondary outcome, recurrent ischaemic stroke (a further stroke caused by a blockage) was reported in 1 participant in the enoxaparin group and 0 in the aspirin group, while 9 enoxaparin participants and 10 aspirin participants did not have a recurrent ischaemic stroke. It is worth noting that this was a very small study of only 20 people, and the data as submitted does not include any further breakdown of the other secondary events (such as heart attack or deep vein thrombosis) beyond what is described above — those figures were not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01478321 · results posted 12 March 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people who had a type of recurrent brain cancer called high-grade malignant glioma — meaning their cancer had come back after earlier treatment. All 54 participants received a combination of re-irradiation (radiation therapy), a chemotherapy drug called temozolomide, and a targeted medicine called bevacizumab given together over five weeks, followed by further courses of the same medicines. The trial was primarily measuring how long participants lived overall, and also looked at how long their disease stayed stable, their quality of life, and side effects they experienced. The reported data shows that the middle value for overall survival — that is, the point at which half the participants had died and half were still alive — was 8.5 months from the start of re-irradiation. For disease stability (called progression-free survival, meaning the cancer had not grown or the person had not died), the reported middle value was 5.5 months. At six months, 48% of participants were reported to still be free of disease progression, and at twelve months that figure was 12%. In terms of how the cancer responded to treatment during the trial, the reported data shows 3 participants had a complete response (no detectable cancer signs), 10 had a partial response (cancer shrank significantly), 28 had stable disease (cancer neither shrank significantly nor grew), 9 had progressive disease (cancer grew), and 4 participants' response was not assessed. The reported data also included quality-of-life questionnaire scores and a record of side effects experienced by participants. Side effects were graded from mild (Grade 1) to life-threatening (Grade 4), and the data recorded the number of participants who experienced reactions considered possibly related to the study treatments — however, the full breakdown of which specific side effects occurred at each grade was not detailed in the structured data provided. Quality-of-life scores were collected at several points during treatment using standard questionnaires, with scores reported at baseline, end of treatment, and after the first and second cycles, though interpreting those individual numbers meaningfully would require the full context of each questionnaire's scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01189266 · results posted 3 March 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01189266) enrolled a total of 79 participants across three groups. Six people were in a lower-dose testing group (Group 1), six were in a higher-dose testing group (Group 2), and 67 were in the main evaluation group (Group 3). The trial was studying a medicine called vorinostat, given alongside chemotherapy and radiation, and then continued as a maintenance (ongoing) treatment. The trial was looking at what dose of vorinostat could be given, how long participants went without their disease getting worse, and how many experienced serious side effects (defined as grade 3 or higher on a standard medical scale — meaning significant or severe reactions). The reported data shows that the highest dose identified in the early testing phase was 230 mg/m² (a dose calculated based on body surface area). For how long participants went without disease progression — called "event-free survival," expressed as a percentage probability — the reported figures were 0% for Group 1, 0% for Group 2, and 3.1% for Group 3. For overall survival (the probability of still being alive at the end of follow-up), the reported figures were 22% for Group 1, 0% for Group 2, and 3.1% for Group 3. Regarding serious side effects during the combined chemotherapy and radiation phase, 5 of 6, 2 of 6, and 24 of 67 participants were reported to have experienced them across the three groups respectively. During the maintenance phase, those numbers were 6 of 6, 4 of 6, and 39 of 67. For the laboratory measure looking at chemical changes in blood cells (H3 and H4 acetylation levels), no measurement data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02336451 · results posted 21 February 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 156 people in total across five groups. Participants had a type of lung cancer involving a gene change called ALK, and all had cancer that had spread to the brain. The five groups differed by their treatment history — for example, whether they had previously received a type of drug called an ALK inhibitor and/or previous brain radiation. The trial was measuring how the cancer responded to the study treatment, both across the whole body and specifically in the brain. The reported data shows that for the main measure — the proportion of participants whose cancer showed a meaningful reduction or disappearance across the whole body (called the overall response rate) — the figures ranged from 16.7% in the group with a specific type of brain involvement (Arm 5) up to 59.1% in the group that had received neither a prior ALK inhibitor nor prior brain radiation (Arm 4). The other arms fell in between, at 35.7% (Arm 1), 30.0% (Arm 2), and 50.0% (Arm 3). For the secondary measures looking at the brain specifically, the proportion of participants whose brain tumours showed a meaningful reduction ranged from around 12.5% to 58.8% depending on the group and who did the assessment. A broader measure — which also counted people whose cancer stayed stable rather than growing — ranged from roughly 67% to 85% across the groups for both whole-body and brain assessments. No participants were recorded as having formally "completed" the study, with all participants listed under "not completed" — the reason for this is not explained 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 ↗

  • NCT01985971 · results posted 31 January 2020

    According to the results reported on ClinicalTrials.gov, this trial involved just 2 participants who received an imaging procedure using a substance called F18 EF5 as part of a PET/CT scan — a type of medical imaging. One participant completed the study, while the other did not finish. The trial was measuring whether any unwanted or harmful reactions (called adverse events) occurred during or after the imaging procedure. The reported data shows that out of the participants assessed, zero (0) experienced any adverse events. It is worth noting that because only 2 people took part and the numbers are very small, this is an extremely limited dataset. No other outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00390299 · results posted 2 January 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total across five groups. Participants were split into two main treatment arms — "Arm A," where a study treatment was delivered into the cavity left after brain tumour surgery (10 people across three dose levels), and "Arm B," where it was delivered both directly into the tumour and into the surgical cavity (13 people across two dose levels). The trial was primarily looking at whether increasing doses caused serious side effects, and at what dose level those serious side effects might begin to appear. The reported data shows that, across all five dose groups, zero out of 23 participants experienced what the researchers defined as a "dose-limiting" side effect — that is, a side effect severe enough to set a ceiling on the dose. When looking at serious adverse events more broadly (rated Grade 3 or higher on a standard scale, meaning significant or severe), 6 out of 9 participants in Arm A and 5 out of 14 participants in Arm B were reported to have experienced at least one such event. For the secondary outcomes, the reported data shows that at 3 months, roughly 56% of Arm A participants and 62% of Arm B participants had not yet had their disease progress; by 6 months those figures were approximately 22% and 23% respectively. The reported median overall survival — meaning the point at which half the participants in each group had died and half had not — was 11.8 months for Arm A and 11.4 months for Arm B. Data for a laboratory measure called CEA titers 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 ↗

  • NCT00263588 · results posted 12 December 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 242 people across two groups: 95 participants in Cohort A and 147 in Cohort B. The trial was measuring how brain tumours that had spread from a type of breast cancer (one that overproduces a protein called ErbB2, also known as HER2) responded to a medicine called lapatinib. The main thing researchers were tracking was whether the brain tumours shrank by at least half in volume on MRI scans, with no worsening of symptoms or spread elsewhere — this was called a "CNS objective response." It is worth noting that a relatively small number of participants completed the study: 14 in Cohort A and 15 in Cohort B. The reported data shows that, for the main outcome — the rate of participants whose brain tumours met the criteria for a full or partial response — 6% of participants in both Cohort A and Cohort B reached that threshold. When looking at disease control (meaning tumours that were either responding or staying stable) at six months, the reported figures were 9% for Cohort A and 2% for Cohort B. For a secondary measure — improvement in neurological signs and symptoms (things like strength, sensation, and coordination) — the data reported that 24 out of the combined group showed some form of improvement, though the full breakdown across categories was not clearly separable from the data as submitted. The reported median duration of a CNS objective response (how long that response lasted) was approximately 2.43 months for Cohort A and 1.58 months for Cohort 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 ↗

  • NCT01975701 · results posted 4 December 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01975701) enrolled 26 people, all of whom received a treatment called BGJ398 (also referred to as BGJ398X). Participants had a type of brain tumour called glioblastoma (GBM) or a related brain tumour, and all had specific genetic changes in a gene family called FGFR. The trial was measuring how long participants went without their tumour growing (called progression-free survival), how many participants' tumours shrank or disappeared (overall response rate), and how long participants lived overall (overall survival). Only 1 of the 26 participants completed the study, with 25 not completing it for reasons not detailed here. The reported data shows that the median progression-free survival — meaning the midpoint time before tumours started growing again — was 1.7 months. The median overall survival — the midpoint time participants were alive — was reported as 6.74 months. For the overall response rate, the reported data shows counts across different response categories: 2 participants had a partial response (tumour shrank), 7 had stable disease (tumour neither shrank nor grew significantly), 13 had progressive disease (tumour grew), and 3 were listed as "not evaluable," with 1 in another category. Regarding side effects and tolerability, the reported data shows 13 participants experienced adverse events (unwanted health changes observed during the trial) and 4 experienced serious adverse events, though further detail on the nature of these events was not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01756352 · results posted 30 October 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people, all of whom had a form of brain cancer called glioblastoma that had come back after earlier treatment. Twelve of the 13 participants completed the study, and one did not. The trial was looking at whether a special type of brain scan — called an FET-PET scan, which uses a mildly radioactive tracer to highlight areas of the brain — could be useful for predicting how long patients might go without their cancer getting worse, and how long they might survive overall. The reported data shows that, on average, participants went approximately 158 days (a little over five months) before their cancer was recorded as progressing — this is referred to as "progression-free survival," meaning the length of time without the disease getting noticeably worse. The reported data also shows that the average overall survival — meaning the length of time participants lived from the point measured — was approximately 271 days (roughly nine months). These figures are group averages as submitted to ClinicalTrials.gov, and no further breakdown of the numbers was reported in the structured 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 ↗

  • NCT02336165 · results posted 28 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02336165) enrolled 159 people across five groups — called Cohort A (40 people), Cohort B (31), Cohort B2 (33), Cohort B3 (33), and Cohort C (22) — all of whom had a type of brain tumour. The trial was testing a medicine called durvalumab and was measuring how many participants were still alive or had not seen their disease worsen after a set period of time, depending on which group they were in. The reported data shows the following results for the main (primary) measurements: In Cohort A, 60% of participants were reported to be alive at 12 months. In Cohorts B, B2, and B3 — where the key measure was how many people had not seen their disease progress by 6 months — the figures reported were 19.4%, 15.2%, and 17.2% respectively. In Cohort C, 36.4% of participants were reported to be alive at 6 months. For secondary measurements, the reported data shows the middle point (median) for how long participants went without their disease worsening ranged from 7.9 weeks (Cohort C) to 19.9 weeks (Cohort A), while the median overall survival ranged from 19.3 weeks (Cohort C) to 64.8 weeks (Cohort A). The number of participants who completed the full study was low across all groups — ranging from zero to six people per group — though the data does not fully explain the reasons for this in the structured results 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 ↗

  • NCT02804750 · results posted 25 September 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in a low-dose group and 18 people in a high-dose group, for a total of 35 participants. The trial was testing a medicine called CORT125134 and was set up across multiple periods (or stages). The main things being measured were how many participants experienced any unwanted health events (called adverse events) during the trial, and how many experienced severe ones. Secondary measurements looked at whether participants with high blood pressure or blood sugar problems showed certain improvements on set definitions. The reported data shows that, for any adverse event of any kind, 15 out of 17 people in the low-dose group and all 18 out of 18 in the high-dose group recorded at least one. For severe adverse events (graded as serious on a standard medical scale), 3 out of 17 in the low-dose group and 7 out of 18 in the high-dose group were reported to have experienced one. On the secondary blood pressure measure, approximately 42% of eligible low-dose participants and approximately 64% of eligible high-dose participants met the trial's definition of a blood pressure improvement. For blood sugar control, using the trial's original definition, about 23% of eligible low-dose participants and 0% of eligible high-dose participants met the target; however, using a different definition applied after the trial was completed, approximately 15% of eligible low-dose participants and 50% of eligible high-dose participants met that revised measure. It is worth noting that the data reports participant counts (not percentages) for the adverse event outcomes, so the "percentage" labels in those results appear to reflect raw numbers of participants rather than calculated percentages. Where any figures were not separately broken down in the submitted data, those details were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02186509 · results posted 9 September 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people, and all 17 completed the study. Participants received a combination of a drug called alisertib and a targeted form of radiation therapy known as fractionated stereotactic radiosurgery (a precise type of radiation treatment aimed at specific areas of the brain). The trial was primarily looking to find the highest dose of alisertib that could be given alongside the radiation treatment before too many participants experienced serious side effects — this is known as the "maximum tolerated dose." The reported data shows that the maximum tolerated dose of alisertib was identified as 50 mg. For the secondary measurements, which looked at how participants' disease responded to treatment, the reported data shows that none of the 17 participants had their tumour shrink or disappear (what researchers call a complete or partial response) based on the criteria used. Of the 17 participants, 6 were reported as having their disease not progress (get worse) at the 6-month mark, and 15 of the 17 participants were reported as still being alive at 6 months. It is important to note that this type of trial — often called a Phase 1 trial — is primarily designed to find a safe dosing level, not to draw broad conclusions about whether a treatment works across a wider population. The reported data shows only what was measured in these 17 participants under the specific conditions of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02031237 · results posted 26 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total across three treatment groups: 14 received Stereotactic Radiosurgery (SRS, a focused form of radiation), 35 received Whole Brain Radiation Therapy (WBRT), and 3 received Stereotactic Radiation Therapy. The trial was measuring how radiation treatment affected the "blood-tumour barrier" (BTB) — a kind of protective lining around brain tumours — by looking at how leaky or permeable that barrier was before, during, and after radiotherapy. Leakiness was measured using a special MRI scan technique that produces a number called Ktrans (a measure of how easily a substance passes through the barrier), with a higher number meaning a leakier barrier. The reported data shows that, for the main outcome, researchers looked at 50 tumour spots from 21 WBRT patients and 14 spots from 9 SRS patients. The WBRT tumour spots were divided into "high-leaky" (43 spots) and "low-leaky" (7 spots) groups based on scans taken before treatment; all 14 SRS spots fell into the high-leaky group. Before treatment began, the reported percentage of tumour volume with a Ktrans above the threshold was 78.6% for SRS lesions, 85.6% for high-leaky WBRT lesions, and 6.4% for low-leaky WBRT lesions. During treatment, those figures were reported as 74.4%, 81.3%, and 30.2% respectively. One month after treatment, the reported figures were 75.3%, 76.7%, and 52.6%. For the remaining primary outcome (looking at regional variability of barrier permeability across the tumour, its edges, and surrounding normal brain) and the secondary outcome (mean Ktrans change over the course of treatment), the data was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00902577 · results posted 8 April 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people who had been newly diagnosed with glioblastoma multiforme, a type of brain tumour. The study was not testing a new treatment — instead, it was investigating whether different types of brain scans taken at the start of the study could predict how long patients lived or how long it took for their disease to progress. The scans included specialised PET scans (which looked at oxygen levels in the tumour) and several types of MRI scans (which looked at blood flow, blood volume, and water movement within the tumour). Of the 50 people who started, 42 completed the study and 8 did not. The reported data shows that the number of participants whose scan results could be fully analysed varied depending on the type of scan. For the primary question — whether baseline scan features were linked to overall survival (how long patients lived) — between 20 and 25 participants had evaluable results depending on the scan type. For the secondary question about time to disease progression, between 20 and 29 participants contributed data. The reported data also shows that two ways of measuring tumour oxygen uptake on PET scans (called T/Bmax and T/Cmax) were very closely related to each other, with a reported correlation of 0.98 out of a possible 1.0. For the reproducibility of the PET scan measurements — that is, how consistent the results were when the same scan was repeated — the variation between repeat scans was reported to be between roughly 7% and 10%. The reported median overall survival was 408 days and the reported median time to disease progression was 258 days, though these figures simply describe what was observed in this particular group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT02410577 · results posted 19 March 2019

    According to the results reported on ClinicalTrials.gov, this trial involved just 2 participants, both of whom completed the study. The trial was testing a radioactive imaging agent called 89Zr-J591, which is designed to be used in a type of scan called a PET scan. The main thing researchers were looking to measure was whether this agent would attach (or "bind") to its target in the body, which would show up on the scan. The reported data shows that although the primary outcome measure — the uptake of 89Zr-J591 seen on PET scans — was listed in the trial's results, no actual numbers or measurements were provided for this outcome. In other words, the result for the key thing being measured was not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01044966 · results posted 12 February 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a combination of two treatments: ITV DepoCyt (a chemotherapy drug delivered directly into a body cavity) and temozolomide (a chemotherapy tablet taken by mouth). The trial was designed for people whose brain tumour known as glioblastoma (GBM) had come back after earlier treatment. The main thing the trial set out to measure was how many participants experienced side effects that were considered related to the study treatments, using a standard medical checklist called CTCAE v4.0. All 12 participants completed the first phase of the trial (called the Induction Phase), but only 2 of the 12 went on to complete the second phase (the Consolidation Phase). The reported data shows that all 12 participants experienced at least one treatment-related side effect, as recorded by the CTCAE checklist. For the secondary measures — which looked at additional questions beyond the main focus — the data shows that 12 out of 12 participants were counted in relation to the 16-week progression-free measure (meaning tumour growth or spread had not met the threshold for worsening, as defined by standard imaging criteria). However, only 2 out of 12 participants were counted as being progression-free for the "progression-free survival" outcome, 2 out of 12 were recorded as having a response to the treatment (defined as stable neurological examination with no signs of progression), and 2 out of 12 were recorded as having an improvement in quality of life scores on the standard questionnaire used (EORTC QLQ-C30). The reported data does not include further breakdown of the side effect types or severity. It is worth noting that the gap between the 16-week progression-free figure (12 participants) and the progression-free survival figure (2 participants) is not fully explained in the data as submitted, and the figures should be interpreted with that limitation in mind. The trial involved a very small number of people, which the reported data does not comment on further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00602667 · results posted 30 January 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 290 children with medulloblastoma (a type of brain tumour), divided into three groups based on their level of risk: 57 in the low-risk group, 156 in the intermediate-risk group, and 77 in the high-risk group. The trial was measuring how long patients went without their disease getting worse (called "progression-free survival" and "event-free survival"), as well as looking at the genetic and chromosomal features of their tumours. Only patients who received any amount of the chemotherapy drug methotrexate were included in the survival analyses. The reported data shows that the percentage probability of remaining free from disease progression differed across the three risk groups. For the low-risk group, the reported figure was approximately 73.9%; for the intermediate-risk group it was 46.9%; and for the high-risk group it was 30.8%. These same figures were also reported for event-free survival (which additionally counts second cancers or deaths from any cause). When researchers further broke down results by the tumour's molecular subtype — categories known as SHH, Group 3, and Group 4 — the reported progression-free survival figures varied across subgroups, ranging from approximately 9.1% to 73.9%, though some subgroup figures were not reported in the data. The secondary outcomes recorded how many participants had certain chromosomal changes or gene alterations in their tumours, with numbers varying across the risk groups, but detailed breakdowns for every category were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01846871 · results posted 8 January 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people with recurrent glioblastoma (a type of aggressive brain tumour that had come back after previous treatment). All 10 participants completed the study. The trial was testing a drug called tivozanib, and the main thing researchers were looking to measure was how many patients were still alive and had not seen their disease get worse six months after starting the treatment. The reported data shows that out of the 10 participants, only 1 was alive and free from disease progression at the six-month mark — the key measure the trial was designed to assess. When looking at survival over time, the reported median overall survival (meaning the point at which half the participants had passed away) was 8.1 months from the start of treatment. The median progression-free survival — the midpoint for how long it took before the disease got worse or a participant died — was reported as 2.3 months. In terms of how the tumour responded, the reported data shows 1 participant had a complete response (tumour disappearing on scans), 1 had a partial response (tumour shrinking), 4 had stable disease (tumour neither clearly growing nor shrinking), and 4 had disease progression (tumour growing). Regarding serious side effects considered related to the treatment, the reported data shows 0 participants experienced any. 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 ↗

  • NCT00720356 · results posted 26 October 2018

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — erlotinib and bevacizumab — in people with a type of brain tumour. A total of 115 people entered the initial registration process, but 48 went on to receive the combination treatment and were fully followed up. The trial was measuring how long participants lived overall, how many were free from their cancer getting worse at certain time points, and how tumours responded to the treatment. The reported data shows that, on average, participants who received the combination treatment lived for 13.2 months from the start of treatment (this is called "overall survival" — meaning the time from starting treatment until death from any cause). When it came to the cancer not getting worse, 32% of participants were reported to be free from progression at 12 months (meaning their disease had not grown or spread). Looking at how tumours responded during treatment, out of 46 participants assessed: 4 had a complete disappearance of measurable disease, 12 had tumours shrink by at least half, 28 had stable disease (no major change), and 2 had their disease get worse. The 18-month progression-free survival figure was not reported in the submitted data. Some side-effect (adverse event) numbers were also submitted, but the data as reported does not include enough labels to describe each individual figure clearly. 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 ↗

  • NCT01977677 · results posted 3 July 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01977677) looked at a drug called plerixafor, given at two different daily doses — 200 micrograms per kilogram and 400 micrograms per kilogram — alongside radiation treatment for people with brain cancer. A total of 30 people took part across three groups: 3 people received the lower dose, 6 received the higher dose in an initial testing phase, and 21 received the higher dose in a later expanded phase. The trial was primarily measuring two things: whether the drug caused serious side effects at each dose level (called "dose-limiting toxicity"), and how many participants were still alive and had not seen their disease get worse six months after starting radiation. The reported data shows that, when it came to serious side effects considered to be related to plerixafor, zero participants in any of the three groups experienced what the researchers classified as a dose-limiting toxicity. For the second primary measure — the number of people alive and without their disease getting worse at the six-month mark — the reported figures were: 3 out of 3 participants in the lower-dose escalation group, 5 out of 6 in the higher-dose escalation group, and 19 out of 21 in the higher-dose expansion group. One participant in the expansion group did not complete the study, and no reason for non-completion is specified in the reported data. It is worth noting that this was a relatively small trial, and the data reported here covers only the specific measurements the researchers set out to track. 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 ↗

  • NCT02337491 · results posted 9 April 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 50 in Cohort A, who received a combination of two medicines called pembrolizumab and bevacizumab, and 30 in Cohort B, who received pembrolizumab alone. The trial was studying these treatments in people with a type of brain tumour, and it was measuring things like how many participants were still alive and their disease had not grown after six months, how long participants lived overall, and how long it was before the disease showed signs of growing. An early safety phase within Cohort A also looked at whether the starting dose of pembrolizumab caused serious side effects (called dose-limiting toxicities) that would require a lower dose to be used. The reported data shows that in the safety lead-in phase, none of the participants experienced a dose-limiting toxicity, and the starting dose of 200 mg of pembrolizumab every three weeks was recorded as the recommended dose going forward. For the main six-month progression-free survival measure — meaning the proportion of people still alive with no sign of their disease growing at the six-month mark — the reported data shows 0.26 (roughly 26 in every 100 participants) in Cohort A and 0.067 (roughly 7 in every 100 participants) in Cohort B. For overall radiographic response — meaning scans showing a meaningful shrinkage of the tumour — the reported figure was 20% for Cohort A and 0% for Cohort B. The reported data shows that the median time before disease progression or death (progression-free survival) was 4.1 months for Cohort A and 1.4 months for Cohort B. The median time participants were reported to have lived from the start of the study (overall survival) was 8.8 months for Cohort A and 10.3 months for Cohort B. It should be noted that the trial recorded zero participants as having "completed" the study, which the data indicates reflects the way completion was defined in this trial rather than meaning all participants left early. 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 ↗

  • NCT01657799 · results posted 14 February 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 307 people with brain metastases (cancer that has spread to the brain) across three groups. Around 102 people received a dummy tablet (placebo) twice daily alongside whole-brain radiation therapy (WBRT — a treatment that delivers radiation to the entire brain), 103 received a lower dose of the study drug veliparib (50 mg twice daily) plus WBRT, and 102 received a higher dose of veliparib (200 mg twice daily) plus WBRT. The trial was measuring how long people lived overall, how well the brain tumours responded to treatment on scans, and how long it took before the brain cancer showed signs of getting worse — either on imaging or based on clinical assessment by doctors. The reported data shows that for overall survival (the number of days from the start of the study until death), the placebo group had a median of 185 days, while both veliparib groups had a median of 209 days. Regarding tumour response on brain scans — meaning the proportion of people whose tumours either disappeared completely or shrank by at least half — the reported figures were 41.2% in the placebo group, 36.9% in the lower-dose veliparib group, and 42.2% in the higher-dose veliparib group. For the time until brain scans showed the cancer growing again, the placebo group's median was 259 days, compared with 226 days and 224 days in the lower- and higher-dose veliparib groups respectively. The reported data also shows that the time until doctors clinically assessed the brain cancer as having progressed was a median of 348 days in the placebo group, 286 days in the lower-dose group, and 255 days in the higher-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00482677 · results posted 23 January 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 562 people in total — 281 in a group receiving a chemotherapy medicine called temozolomide, and 281 in a group receiving radiation therapy. All participants who started the trial were recorded as having completed it. The trial was comparing these two treatments in people with a type of brain tumour, looking mainly at how long participants lived overall, and also at how long they lived before their disease got worse. The reported data shows that, for overall survival — meaning the time from joining the trial until death from any cause — the temozolomide group had a reported median (the midpoint figure, where half lived longer and half lived shorter) of around 9.33 months, while the radiation group had a reported median of around 7.62 months. For progression-free survival — meaning the time before the disease got worse or death occurred — the reported medians were 5.29 months for the temozolomide group and 3.94 months for the radiation group. The trial also looked at a biological marker called MGMT methylation status, which relates to a chemical change in a gene that may influence how tumours behave. Among participants whose tumours had this marker, the reported median overall survival was 13.47 months in the temozolomide group and 7.69 months in the radiation group. Data on adverse events (unwanted side effects) was listed as a secondary outcome but no specific numbers were 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 ↗

  • NCT02299089 · results posted 15 December 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02299089) enrolled 12 people in total — 7 with a condition called acromegaly (a hormonal disorder) and 5 with neuroendocrine tumours (NETs, a type of tumour that can affect various organs). All 12 participants completed the study, with no drop-outs. The trial was measuring how a drug called CAM2029 — a new formulation of a medicine called octreotide — was absorbed and moved through the body compared with an existing version of the same medicine called Sandostatin LAR. This type of measurement is called pharmacokinetics, which simply means tracking how much of a drug gets into the bloodstream, how high the levels peak, and how much remains between doses. The reported data shows three main blood-level measurements were tracked for both the existing Sandostatin LAR and the new CAM2029. For Sandostatin LAR, the total drug exposure over 28 days (a measure of how much drug was present in the blood overall) ranged from 6.23 to 39.9 day\*ng/mL depending on the dose and condition. The peak blood level reached ranged from 0.349 to 2.48 ng/mL, and the lowest level recorded just before the next injection ranged from 0.225 to 1.27 ng/mL. For CAM2029, the reported data shows notably higher numbers across all groups: total drug exposure over 28 days ranged from approximately 72.4 to 135 day\*ng/mL, peak blood levels ranged from 5.61 to 16.3 ng/mL, and the lowest levels between doses ranged from 0.403 to 1.81 ng/mL. These figures were recorded at two different time points during the CAM2029 treatment period, and the numbers were broadly similar at both points. It is important to note that this was a very small study involving just 12 participants, and its purpose was to measure drug levels in the blood rather than to draw conclusions about how well the treatment worked for patients. The reported data shows only what drug concentrations were observed — no conclusions about patient outcomes were reported 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 ↗

  • NCT00105560 · results posted 21 August 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 59 participants, all of whom received radiation therapy. Fifty-eight participants completed the study. The trial was looking at children who had received radiation treatment, and it was tracking three main things over time: whether participants experienced hearing problems (called ototoxicity), whether they developed hormonal problems (called endocrine dysfunction), and whether their thinking and learning abilities (neurocognitive outcomes) changed during the follow-up period. The reported data shows that when it came to hearing problems, around 12% of participants had developed this issue by the 3-year follow-up point, rising to 16% by 5 years and remaining at 16% by 7 years. For hormonal problems, the reported figures grew noticeably over time — across the overall group, 27% were recorded as having experienced some form of hormonal issue at 3 years, rising to 55% at 5 years, and 63% at 7 years. Regarding thinking and learning abilities, participants were tested using a standard intelligence scale where a score of 100 is considered average in the general population. The reported data shows that scores declined over time across several areas measured — for example, overall thinking ability declined by an average of 1.5 points per year, and the area of processing speed showed the largest average annual decline of 2.4 points per year, based on a median follow-up of around 5 years. 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 ↗

  • NCT00540722 · results posted 12 July 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 participants, all of whom were assigned to receive a treatment called R-(-)-Gossypol Acetic Acid. All 56 participants completed the study. The trial was measuring how long participants survived overall, how long they lived without their disease getting worse, how their tumours responded to the treatment, and what serious side effects occurred. The reported data shows that the median overall survival — that is, the point at which half of participants had passed away and half had not — was 5.9 months. For progression-free survival (the time participants were alive with their disease not getting worse), the reported figure was 1.87 months. Looking at tumour response among the 56 participants: no participants had a complete disappearance of their tumour; 1 had a partial response (tumour shrinking by at least half); 15 had stable disease (tumour neither shrinking nor growing enough to count as either response or progression); 35 had progressive disease (tumour growing or new lesions appearing); and 5 were recorded in a separate category. Regarding serious side effects (graded as severe or life-threatening, known as Grade 3 or 4), the reported data shows small percentages — figures of 2%, 2%, 2%, 4%, and 2% — across different categories of side effects, though the specific side effect for each figure was not individually labelled in the submitted data. The reported data also notes that a separate exploratory analysis looking at blood markers and tumour tissue characteristics was planned, but no numerical results for that measure were included in the submitted data — so those findings 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 ↗

  • NCT01268566 · results posted 6 April 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 participants, all of whom received a single treatment — MEDI-575 at a dose of 25 mg/kg. MEDI-575 is a type of antibody treatment being studied in people with a form of brain cancer called high-grade glioma. The trial was primarily looking at how many participants were still alive and had not seen their cancer grow six months after starting treatment. Of the 56 people who started, 13 completed the study and 43 did not complete it. The reported data shows that 15.4% of participants — roughly 1 in 6 — were free from disease progression (meaning their cancer had not grown or spread) and still alive at the six-month mark. When it came to how the disease responded overall, the reported data shows that no participants had a complete or partial response to treatment (meaning no one's tumour shrank by the amounts needed to count as a response under the study's measurement rules). Around 41% of participants had stable disease (the cancer neither shrank nor grew significantly), while approximately 55% had progressive disease (the cancer grew). About 3.6% of participants could not be assessed. The reported data also shows that the median time to disease progression — that is, the midpoint at which half the participants had seen their cancer begin to grow — was 1.4 months. Data for time to response and duration of response were not reported, likely because no confirmed responses occurred. 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 ↗

  • NCT00027846 · results posted 1 March 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 378 children with ependymoma (a type of brain tumour). Participants were placed into one of three groups based on how much of the tumour was removed by surgery and where it was located: Group 1 (13 children who had a complete or near-complete removal of a certain tumour type in the upper part of the brain), Group 2 (287 children who received radiation therapy), and Group 3 (78 children who had only a partial removal of the tumour). The trial was primarily measuring "event-free survival" — that is, the estimated chance that a child would reach the five-year mark without their disease getting worse, coming back, developing a new tumour, or dying. The reported data shows that the estimated probability of being event-free at five years was 0.614 (roughly 61 in 100) for Group 1, 0.685 (roughly 69 in 100) for Group 2, and 0.372 (roughly 37 in 100) for Group 3. For overall survival at five years — meaning the estimated chance of still being alive — the reported figures were 1.0 (all participants) for Group 1, 0.862 (roughly 86 in 100) for Group 2, and 0.702 (roughly 70 in 100) for Group 3. These are statistical estimates, not exact counts of individuals. The reported data also shows some additional findings for Group 3. Among children in that group who initially had only a partial removal, 76% were reported to have achieved a complete or near-complete removal after a second surgery following chemotherapy. When looking separately at tumour type within Group 3, the five-year event-free survival estimate was 0.424 for those with a less aggressive tumour type (differentiated ependymoma) and 0.298 for those with a more aggressive type (anaplastic ependymoma). 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 ↗

  • NCT00238264 · results posted 23 February 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 92 participants, all of whom received a type of targeted radiation treatment called reduced-field conformal radiation therapy. This approach aims to focus radiation more precisely on a tumour rather than a wider area. The trial was designed for people with low-grade brain tumours (called low-grade gliomas) that had come back, were growing, or were causing symptoms. Of the 92 people who started, 56 completed the study and 36 did not complete it. The main thing the trial was measuring was whether any tumour recurrences happened right at the edge of the treated area — what researchers call a "marginal failure." The reported data shows that for the primary outcome, the marginal failure rate was reported as 0%, meaning that among those who experienced a recurrence, none were recorded as occurring at the edge of the treated area. For the secondary outcomes, the reported data shows that approximately 77.1% of participants were free from their disease progressing or from a study-defined "event" at the three-year mark (these two measures gave the same figure). The three-year overall survival rate — meaning the proportion of participants still alive at three years — was reported as 94.0%. The reported data also includes a laboratory measurement called the MIB-1 labelling index, which reflects how actively tumour cells were dividing, and this was reported as 3.1% of tumour cell nuclei. Quality of life was listed as a secondary outcome, but no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01310855 · results posted 27 January 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01310855) enrolled 38 people in total — 19 in a group receiving cediranib combined with gefitinib, and 19 in a group receiving cediranib combined with a placebo (an inactive dummy pill). All 38 participants completed the study period. The trial was primarily measuring "progression-free survival" — that is, how long participants went before their condition worsened or they passed away, whichever came first. The reported data shows that, for the primary outcome, the cediranib and gefitinib group had a median progression-free survival of 3.6 months, while the cediranib and placebo group had a median of 2.8 months. (Median here simply means the middle value — half the participants in each group reached that point sooner, and half took longer.) For all six of the secondary outcomes — including overall survival, radiographic response rate (tumour changes seen on scans), progression-free survival at six months, steroid use, and time to deterioration of neurological status — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00100802 · results posted 13 January 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 118 participants who went through a treatment programme involving surgery, chemoradiotherapy (a combination of chemotherapy and radiation treatment), a rest period, maintenance therapy, and follow-up care. The trial was measuring two main things: how many participants were still alive one year after starting the programme, and whether any deaths occurred that were linked to complications from the treatment itself. Of the 118 people who started, 38 completed the full programme, while 80 did not complete it — the reasons for this were not detailed in the reported data. The reported data shows that the estimated probability of surviving to the one-year mark was approximately 0.72, meaning that based on a statistical estimation method called Kaplan-Meier (which uses the data from all participants to estimate survival over time), roughly 72 in every 100 participants were estimated to be alive at one year. For the second main measure, the reported data shows that 1 participant died from complications that were attributed to the treatment protocol itself. It is worth noting that these numbers describe what was recorded and reported for this specific group of trial participants under controlled research conditions, and they may not reflect what would happen in other settings or for other 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 ↗

  • NCT01577966 · results posted 8 December 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom completed the study — none dropped out. All participants were given a medicine called sulfasalazine. The trial was looking at whether sulfasalazine could reduce levels of a chemical called glutamate inside brain tumours known as gliomas. Glutamate levels were measured using a brain scanning technique called Magnetic Resonance Spectroscopy (MRS), which can detect certain chemicals in the brain without surgery. The reported data shows the main outcome measured was the percentage decrease in glutamate levels inside the tumour for each individual participant. The nine reported percentage decreases were: 17%, 23%, 28%, 5%, 55%, 58%, 12%, 18%, and 42%. These figures represent how much each person's tumour glutamate level changed during the trial. No single combined or average figure was reported in the structured results data — only the individual results for each participant. No secondary outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01371643 · results posted 22 July 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people in total. Fifteen participants were assigned to receive a medication called Octreotide LAR on its own, while 26 participants received surgery first, followed by the same medication. The trial was measuring how many people in each group reached a specific biochemical target — a combination of low growth hormone levels (measured during a sugar drink test) and normal levels of another hormone called IGF-I, which are standard markers used to assess a condition called acromegaly. The reported data shows that, looking at the response to each group's primary treatment alone, 6.7% of participants in the medication-only group met the target, compared with 50% of participants in the surgery-plus-medication group. When the full course of all treatments was taken into account (meaning medication given after surgery was also counted for the surgery group), the reported figures were 6.7% for the medication-only group and 76.9% for the surgery-plus-medication group. A secondary measure looked only at people in the surgery group who did not respond to surgery and then received medication — the reported data shows 53.9% of that subgroup met the target. Three participants in the medication-only group did not complete the study, while all 26 in the surgery group completed it; reasons for non-completion in the medication group were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00057746 · results posted 25 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 265 people across three groups: 131 participants in Arm I, 67 in Arm II, and 67 in Arm III. The trial was measuring something called "chronic neurotoxicity" — in plain terms, this meant looking at whether participants experienced a meaningful decline in certain thinking and memory skills over one year, as measured by three standard tests covering memory, word finding, and mental processing speed. Importantly, this decline only counted if it happened without the cancer spreading to the brain. The reported data shows that the percentage of participants recorded as experiencing this decline in thinking and memory skills differed across the three groups. In Arm I, 60% of participants were recorded as meeting the criteria for this decline. In Arm II, the reported figure was 85%, and in Arm III it was 89%. The data for one participant in Arm III was not included in the completed count, though no further detail on this was reported. These numbers describe only what was observed and recorded during the trial — they do not on their own tell us why the figures differed between groups, or what those differences mean in practice for any individual. 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 ↗

  • NCT00499473 · results posted 29 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people with brain tumours (gliomas) across two groups. Twenty-seven participants were in "Stratum 1" — people who were *not* taking a type of anti-seizure medication known as enzyme-inducing anticonvulsants (EIACs) — and four participants were in "Stratum 2," who *were* taking those medications. The trial was investigating a drug called sunitinib, and was measuring things like how long participants went without their disease getting worse, the best dose to use (particularly for the EIAC group), and overall survival (how long participants lived). The reported data shows that in Stratum 1, only 1 out of 27 participants was free from their disease getting worse at the 6-month mark. For the confirmed objective response measure — meaning scans showing the tumour had meaningfully shrunk or disappeared — the reported number was zero for both groups. Similarly, the percentage of participants still free from disease progression at 12 months was reported as 0% in both groups. For overall survival (how long, on average, participants lived during the study period), the reported figures were 5.7 months for Stratum 1 and 12.3 months for Stratum 2. The reported data shows that the primary outcomes relating to the maximum tolerable dose and drug concentration levels for the EIAC group were not reported in the submitted results. It is worth noting that Stratum 2 had only four participants, which is a very small number, so the figures from that group should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00456612 · results posted 5 October 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00456612) involved a single group of participants who received a radiation treatment called CyberKnife. Four people were enrolled in the study overall. The trial was measuring how many participants remained free from their condition progressing over time — specifically looking at progression-free survival at six months, as well as broader measures such as tumour response, time until the condition worsened, and overall survival at one year. The reported data shows that of the four people who started the trial, only one completed it, and three did not complete it. However, the actual numerical results for all of the outcome measures — including the six-month progression-free survival rate, tumour response, time to progression, and one-year overall survival — were not reported in the data submitted to ClinicalTrials.gov. Because no measurements were provided for any of the primary or secondary outcomes, it is not possible to describe what those figures showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01402063 · results posted 11 June 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01402063) involved people diagnosed with a type of brain tumour called glioblastoma (GBM) that had a specific genetic characteristic — the absence of a chemical "tag" on a gene called MGMT (known as methylation). A total of 63 people took part: 42 were assigned to receive radiation therapy combined with a drug called PPX (CT-2103), and 21 received radiation therapy combined with a more commonly used drug called temozolomide. The trial's main goal was to measure how long participants went without their tumour growing or spreading — a period known as "progression-free survival." The reported data shows that, for the primary outcome of progression-free survival, 31 out of 42 participants in the radiation-plus-PPX group and 15 out of 21 participants in the radiation-plus-temozolomide group were counted in the measurement. Tumour response was assessed using brain scans (MRI), with changes in tumour size used to classify each person's response — whether the tumour had shrunk, stayed the same, or grown. Beyond these participant counts, the reported data does not include further breakdown figures (such as average survival times or response rates) for this outcome measure, so those numbers cannot be described here. It is also worth noting that 3 participants in each group did not complete the study, though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01663012 · results posted 11 June 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, and all 20 completed the study. Participants had a type of brain tumour (glioma) that had stopped responding to a treatment called bevacizumab. The trial was looking at a drug called etirinotecan pegol (also known as NKTR-102), and the main thing it measured was how many participants went a certain period of time — at least six weeks — without their disease getting worse, based on a standard brain tumour assessment tool called the RANO criteria. The reported data shows that out of the 20 participants, 11 had not experienced disease progression at the six-week mark, according to the RANO assessment. For the additional measures tracked, the reported data shows that the estimated average time participants survived after starting the drug was 4.5 months. The estimated average time participants survived from the point of their original diagnosis was 17.1 months. These figures are summaries across the group and do not represent any individual person's experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00004146 · results posted 8 May 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 55 participants, all of whom completed the study (none dropped out). The trial was looking at a treatment combining a drug called CAI with radiation therapy (RT) in people with a type of brain tumour. The study was measuring three things: how long participants lived overall, how many experienced significant unwanted side effects from CAI when combined with radiation, and how much of the CAI drug was present in participants' blood depending on whether they were also taking certain anti-seizure medications. The reported data shows that the overall survival figure was 10.3 months, measured from the time of diagnosis. This number represents the median — meaning it is the midpoint figure where roughly half of participants lived longer than this and half did not. Regarding side effects, the reported data shows that 16 out of 55 participants experienced what was classified as a grade 3 or higher event (meaning a more serious unwanted effect) that was considered at least possibly related to CAI. The reported data also shows a difference in the amount of CAI measured in the blood depending on whether participants were taking a type of anti-seizure medication known as enzyme-inducing anticonvulsants. Those who were taking these anti-seizure medications had an average blood concentration of 1.3 micrograms per millilitre, while those who were not taking them had a higher average concentration of 4.06 micrograms per millilitre. 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 ↗

  • NCT01462695 · results posted 23 March 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 children or young people with recurring brain tumours — 17 in a group with a type of tumour called high grade glioma (Stratum A), and 13 in a group with a tumour type called ependymoma (Stratum B). The trial was measuring whether tumours showed a meaningful reduction in size that lasted for at least 8 weeks, which the researchers called a "sustained objective response." None of the participants in either group were recorded as having formally completed the study. The reported data shows that the sustained objective response rate — the percentage of patients whose tumours shrank significantly and stayed smaller for at least 8 weeks — was 0% in both groups. In plain terms, according to the reported numbers, none of the 17 participants in the high grade glioma group and none of the 13 participants in the ependymoma group met this particular measure of tumour shrinkage during the trial. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT01549392 · results posted 15 September 2014

    According to the results reported on ClinicalTrials.gov, this trial looked at the use of two specialised scanning techniques — dual-energy CT (a type of X-ray scan) and MR spectroscopy (a type of MRI scan) — to monitor brain tumour (glioma) patients. The study had two groups: patients receiving a drug called Avastin (bevacizumab), and glioma patients not receiving Avastin. A total of 3 people were enrolled in the Avastin group, and no participants were enrolled in the non-Avastin group. Of the 3 who started, 2 completed the study and 1 did not. The reported data shows that the primary outcome being measured was tumour size reduction at 3 months in the group receiving Avastin. According to the results reported on ClinicalTrials.gov, a value of 3 participants was recorded against this outcome measure. However, the data as submitted is limited — no results were reported for the non-Avastin group (since no one was enrolled in it), and no further detail about the measurements or how tumour changes were assessed was included in the submitted results. It is worth noting that this was a very small study, and the results data provided on ClinicalTrials.gov is minimal. Several outcome details were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01363986 · results posted 11 August 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01363986) enrolled 3 participants, all of whom received trastuzumab as a single treatment (monotherapy). The trial was set up to look at how brain tumour lesions responded to the treatment in people with cancer that had spread to the brain. The main thing being measured was whether the brain lesions shrank or disappeared by a set point in the treatment schedule (called Cycle 7), using a standard measuring system known as RECIST — a set of rules that classifies responses based on changes in tumour size. The reported data shows that at Cycle 7 (the primary measurement point), 2 out of 3 participants had a recorded brain "objective response," meaning their brain lesions either disappeared completely or shrank by at least 30%. At a later point in the study (Cycle 15), the reported data shows 0 participants had that same level of response. At the final visit, 1 participant was recorded as having a brain objective response, and 1 participant was reported as still surviving. The data for one secondary outcome — how long participants went without their brain disease getting worse (called "Brain Progression-Free Survival") — was not reported in the submitted results. It is worth noting that this was an extremely small trial with only 3 participants, and 1 did not complete the study. The reported data shows numbers only, and no broader conclusions about the treatment can be drawn from such a small 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 ↗

  • NCT00085202 · results posted 27 February 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00085202) enrolled 413 children with medulloblastoma (a type of brain tumour), split into two groups based on how their disease was assessed: 269 in the "average-risk" group and 144 in the "high-risk" group. The trial was measuring several things, including how long participants went without their disease getting worse (called progression-free survival), whether a particular protein called ERBB2 found in tumours was linked to that outcome, the presence of certain gene changes in tumour tissue, and aspects of reading and memory in participants. The reported data shows that among the 122 participants whose tumours were tested for ERBB2, those whose tumours did not show the ERBB2 protein had a reported probability of going two years without disease progression of around 86.7% overall, compared to about 79.2% for those whose tumours did show the protein. When broken down further by risk group, the reported two-year progression-free survival probability was approximately 93.5% for ERBB2-negative/average-risk participants, 83.3% for ERBB2-positive/average-risk, 71.4% for ERBB2-negative/high-risk, and 69.6% for ERBB2-positive/high-risk. On the reading assessment, participants in both the reading intervention group and the standard care group scored in what the scale describes as the average range (104.1 and 102.4 respectively out of a population average of 100). For memory scores at enrolment, the average-risk group scored 93.61 and the high-risk group scored 98.04, both within or near the described average range. Six average-risk participants experienced treatment setbacks in the area of the brain where reduced radiation was used, and this was reported as a safety monitoring figure. Gene mutation data was also reported, though numbers were small and some categories recorded zero mutations detected. 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 ↗

  • NCT00047320 · results posted 27 February 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 104 participants, all of whom had received induction chemotherapy (an initial course of cancer treatment) and went on to receive radiation therapy. The trial was measuring how well participants responded to the induction chemotherapy phase, and then tracking their longer-term outcomes including survival and the occurrence of serious side effects. Of the 104 who started, 76 completed the study and 28 did not complete it. The reported data shows that, when looking at response to induction chemotherapy, 74 participants achieved a complete response and 11 achieved a partial response (meaning their tumour shrank by at least 65%). For the longer-term survival outcomes, the trial used a statistical method called a Kaplan-Meier estimate — a way of calculating the probability, or likelihood, of a particular outcome over time. The reported probability for both "event-free survival" (remaining free from death, disease return, or a new cancer) and "progression-free survival" (remaining free from the disease returning or worsening) was 0.837, which can be read as roughly an 84 in 100 chance. The reported probability for overall survival (remaining alive) was 0.927, or roughly a 93 in 100 chance. The data does not specify over what time period these probabilities were measured. The reported data also shows that no participants died from treatment-related causes, and 22 participants experienced a serious (grade 4) non-blood-related side effect at some point during chemotherapy. 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 ↗

  • NCT00470847 · results posted 20 January 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom received a combination of three treatments: lapatinib (a tablet medicine), whole-brain radiation therapy, and Herceptin (also known as trastuzumab, a targeted medicine given by infusion). Thirty-four of the 35 participants completed the study. The trial was looking at patients with HER2-positive breast cancer that had spread to the brain. The main thing the trial set out to find was the highest dose of lapatinib that could be given alongside the other treatments without causing unacceptable side effects — known as the "maximum tolerated dose." The reported data shows that the maximum tolerated dose of lapatinib in this combination was 1,250 milligrams. For the secondary measurements, the reported data shows that 79% of participants had a measurable reduction or disappearance of tumours in the brain (the "objective response rate" in brain sites). The median progression-free survival — meaning the midpoint length of time before the disease was recorded as worsening or a participant died — was reported as 4.8 months. When progression did occur, the reported data shows it was first seen in the brain in 23% of participants, and first seen outside the brain in 46% of participants. The median overall survival — the midpoint length of time participants lived after starting the study treatment — was reported as 19 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 ↗

  • NCT00328510 · results posted 19 August 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 83 people in total — 42 in one group and 41 in another. The study compared two different ways of keeping a patient's head still during a type of precision brain radiation treatment called stereotactic radiotherapy (SRT). One group used a device called a GTC Frame, which is a rigid frame attached to the head, while the other group used a BrainLab Thermoplastic Mask, which is a moulded plastic mask that fits over the face. The trial measured how accurately each method kept the patient's head in exactly the right position during treatment, using an imaging system to detect any small movements or shifts. The reported data shows that positioning accuracy was measured in millimetres — specifically, how far the patient's head was from the ideal target position on average. For the GTC Frame group, the reported average deviation was 2.00 millimetres, meaning the head was, on average, 2 mm away from the ideal position. For the BrainLab Thermoplastic Mask group, the reported average deviation was 3.17 millimetres. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov. It is also worth noting that 10 people in the GTC Frame group and 4 in the Thermoplastic Mask group did not complete the study, though the reasons were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00943826 · results posted 20 May 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 921 people (458 in one group, 463 in the other) who were being treated for a type of brain tumour called glioblastoma. Participants were randomly assigned to receive either bevacizumab or a placebo (an inactive substance), both given alongside standard treatment — radiation therapy and a chemotherapy medicine called temozolomide. The trial had two main goals: to measure how long people went without their disease getting worse (called progression-free survival), and how long people lived overall. The reported data shows that, for progression-free survival as assessed by the treating doctors, the bevacizumab group had a reported median of 10.6 months compared with 6.2 months in the placebo group. (A "median" simply means the midpoint — half the people in that group had a longer time, half a shorter time.) For overall survival — how long people lived from the start of the trial — the reported median was 16.8 months in the bevacizumab group and 16.7 months in the placebo group, which were very close to each other. A separate review of scans done by an independent team reported progression-free survival medians of 8.4 months (bevacizumab) and 4.3 months (placebo). The reported data also shows that roughly 72 in 100 people in the bevacizumab group and 66 in 100 in the placebo group were estimated to be alive at one year, and approximately 34 in 100 versus 30 in 100 were estimated to be alive at two years. Additional measures looked at how long people went without worsening on quality-of-life questionnaires covering areas such as general health, physical ability, social functioning, and specific brain-related symptoms. The reported figures for these measures ranged from around 4 to 8 months depending on the group and the specific area being assessed, with the bevacizumab group generally reporting slightly longer timeframes across 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 ↗

  • NCT00597402 · results posted 18 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 125 participants, all of whom were treated with a combination of four treatments: Avastin (bevacizumab), radiation, temozolomide, and irinotecan. All 125 participants were recorded as having completed the study. The trial was primarily looking at how many participants were still alive 16 months after starting treatment. It also tracked a number of secondary measures, including how many participants had not experienced their disease getting worse at the 12-month mark, as well as recording certain serious side effects. The reported data shows that 64.8% of participants (roughly 65 out of every 100) were still alive at the 16-month mark. For the 12-month secondary measure — tracking participants who were alive and whose disease had not progressed (gotten worse) — the reported figure was 63.2%. Regarding bleeding events (haemorrhage), the data shows that 1 participant experienced a bleed in the central nervous system (brain or spinal cord) and no participants experienced a bleed elsewhere in the body, though the full breakdown across the multiple reported categories was not entirely clear from the submitted data. The reported data also shows that 20 participants experienced a serious blood-related side effect (graded as severe or higher), and 49 participants experienced a serious non-blood-related side effect of at least a moderately severe grade. It is worth noting that this trial had only one group, meaning there was no comparison group receiving a different treatment, so the numbers above reflect only the experience of participants on this particular combination. 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 ↗

  • NCT01004874 · results posted 18 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people, all of whom completed the study. Participants received a combination of treatments including bevacizumab (also known as Avastin), radiation therapy, temozolomide (a chemotherapy medicine), and topotecan (another chemotherapy medicine). The main thing the trial set out to measure was how many participants went six months without their disease getting worse — known as "progression-free survival at six months." The reported data shows that 88.8% of participants reached the six-month mark without their disease progressing. The middle point for how long participants went without disease progression (called "median progression-free survival") was reported as 11.1 months — meaning half of participants had progression before that point and half after. For overall survival (time from the start of treatment until death from any cause), the reported data shows that 73.8% of participants were alive at one year and 35.6% were alive at two years, with the midpoint for overall survival reported as 17.2 months. Regarding side effects tracked in the trial, 1 participant experienced a bleed in the central nervous system (brain or spinal cord), none experienced a bleed elsewhere in the body, and 2 experienced both types. Additionally, 23 participants experienced serious blood-related side effects (graded at the most severe level) and 17 experienced serious non-blood-related side effects. 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 ↗

  • NCT00777153 · results posted 21 December 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 325 people with brain cancer who had already received prior treatment. Participants were divided into three groups: 131 people received cediranib alone (30mg), 129 received a combination of cediranib (20mg) and a chemotherapy drug called lomustine (110mg), and 65 received lomustine alone (110mg). The trial's main goal was to measure how long people went without their disease getting worse (called "progression-free survival"), and several secondary goals were also tracked, including how long people lived overall, how many showed a measurable reduction in tumour size, and how steroid medication use changed over time. The reported data shows that, for the main outcome, the median number of days without disease progression was 92 days for the cediranib-only group, 125 days for the combination group, and 82 days for the lomustine-only group. For overall survival, the reported median figures were 8.0 months, 9.4 months, and 9.8 months for the three groups respectively. The number of participants who showed a notable reduction or disappearance of their tumour on scans was 18 in the cediranib-only group, 21 in the combination group, and 5 in the lomustine-only group. The reported data also shows that the proportion of people who were still alive and progression-free at six months was approximately 16.2% for cediranib alone, 34.5% for the combination, and 24.5% for lomustine alone. Regarding steroid use, the reported data shows that average daily steroid doses changed by −17.6% (a decrease) in the cediranib-only group, −1.8% (a very slight decrease) in the combination group, and +36.6% (an increase) in the lomustine-only group, compared to where each person started. The number of days participants were recorded as not using any steroids prior to disease progression was reported as 75.8 days, 74.8 days, and 92.3 days for the three groups 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 ↗

  • NCT00187226 · results posted 20 August 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 202 children and young people with brain tumours across six groups, based on tumour type and the size of the treatment margin used during radiation therapy. The two margin sizes studied were 1 centimetre and 2 centimetres around the tumour area. The groups included children with ependymoma (88 participants), low-grade glioma (49 or 1 participant depending on margin group), craniopharyngioma (28 participants), high-grade glioma (34 participants), and a small "other" category (2 participants). All participants who started the study were recorded as having completed it. The primary outcome measured was local tumour control — meaning whether the tumour stayed within the treated area or showed signs of growing back there — checked by MRI scans taken regularly over up to five years. The reported data shows the proportion of participants in each group whose tumour did not progress locally. For the 1 centimetre margin groups, the reported proportions were: ependymoma 0.966 (roughly 97 in 100), low-grade glioma 0.959 (roughly 96 in 100), craniopharyngioma 1.000 (all participants), and the "other" group 1.000 (all participants). For the 2 centimetre margin groups, the reported proportion for high-grade glioma was 0.618 (roughly 62 in 100), and for low-grade glioma 1.000 (the single participant). No secondary outcome data appears to have been 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 ↗

  • NCT00393094 · results posted 6 July 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 31 participants who had a type of brain tumour called a malignant glioma (which includes two sub-types: anaplastic glioma and glioblastoma multiforme). The trial was measuring how tumours appeared on brain scans after treatment with a combination of two drugs — bevacizumab and irinotecan — and also tracking any side effects linked to those drugs. Thirty participants completed the first part of the study. The reported data shows that, when looking at brain scan results, tumour responses were grouped into four categories: complete disappearance of the tumour, partial shrinkage (at least 50% reduction in tumour size), stable or no change, and progression (tumour growing by 25% or more). For the overall malignant glioma group, the reported data shows 0% had a complete response, 0% had a partial response, 16.7% had stable disease, and 83.3% had progression. Breaking this down by tumour type: among participants with anaplastic glioma, 0% had a complete response, 0% had a partial response, 30% had stable disease, and 70% had progression. Among participants with glioblastoma multiforme, 0% had a complete response, 0% had a partial response, 10% had stable disease, and 90% had progression. The reported data also shows that 27 out of 31 participants experienced at least one side effect considered possibly, probably, or definitely related to the study drugs. The trial record notes that a more detailed breakdown of those side effects is available in the adverse events section of the ClinicalTrials.gov record, but that detail was not included in the structured results 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 ↗

  • NCT00576472 · results posted 16 April 2012

    According to the results reported on ClinicalTrials.gov, this trial involved children who had been treated for cancer — including acute lymphoblastic leukaemia (ALL) and brain tumours — along with some of their healthy siblings as a comparison group. The study had several stages. In the first screening stage, 469 participants were assessed across different treatment intensity groups (mild, moderate, and high). Later stages looked at a medication called methylphenidate (commonly known as a stimulant used for attention difficulties) in a laboratory setting, then in a crossover phase where 134 participants received different combinations of the medication and a dummy pill (placebo) in varying orders, and finally in a home maintenance phase involving 118 participants. The trial was measuring brain white matter volume (the amount of a particular type of brain tissue, seen on MRI scans) in patients compared to siblings, and also tracking attention-related behaviours using standard rating scales completed by teachers and parents. The reported data shows that when MRI results were compared, healthy siblings had an average white matter volume of 30.3%, while patients overall averaged 27%. Breaking this down further, ALL patients averaged 28.4% and brain tumour patients averaged 25.5%. When grouped by how intensive the cancer treatment had been, white matter percentages were reported as 28.8% for the mild group, 25.9% for the moderate group, and 25.4% for the high intensity group, compared to 30.3% for siblings. Regarding the attention behaviour scores measured during the home maintenance phase, the reported data shows average changes (from the start to the end of that phase) of minus 7.17 points on the teacher-rated ADHD score, minus 3.34 points on the teacher-rated cognitive problems score, and minus 8.74 points on the parent-rated ADHD score — where a negative number means the score went down (scores on these scales are higher when more difficulties are observed). The completion data was not reported for all sub-groups equally across every phase. 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 ↗

  • NCT00404495 · results posted 17 February 2012

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — temozolomide and irinotecan — in children and young people with one of two types of brain tumour: medulloblastoma or high-grade glioma. A total of 83 participants were enrolled — 66 in the medulloblastoma group and 17 in the high-grade glioma group. Of those, 22 and 6 participants respectively completed the study, while the remainder did not complete it (reasons were not detailed here). The trial's main goal was to measure how many participants showed a meaningful shrinkage of their tumour — defined as either the tumour disappearing completely (complete response) or shrinking by at least half (partial response). The reported data shows that, for the primary measure assessed by an independent review committee, about 32.6% of participants in the medulloblastoma group showed a complete or partial tumour response, while 0% in the high-grade glioma group met that threshold. When the treating doctors made their own assessments (a secondary measure), the figures were 34.9% for the medulloblastoma group and 11.8% for the high-grade glioma group. Among those who did show a response, the reported data shows the middle estimate for how long that response lasted was approximately 22.4 weeks in the medulloblastoma group and 36.3 weeks in the high-grade glioma group. The reported data also shows that the middle estimate for time until treatment stopped working was 3.8 months (medulloblastoma) and 1.6 months (high-grade glioma), time until the tumour progressed was 5.6 months and 1.6 months respectively, and overall survival from the start of treatment was 16.7 months and 9.4 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00253448 · results posted 26 July 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people, all of whom received the same treatment: a combination of stereotactic radiosurgery (a precise, focused form of radiation) plus conventional radiotherapy (a standard course of radiation therapy). Thirty-four of the 35 participants completed the study, with one person not completing it. The trial was measuring how long participants survived after receiving this combined radiation treatment, with follow-up check-ins every 3 months for the first 2 years, then every 6 months for 3 years, and once a year after that for at least 5 years in total. The reported data shows a series of individual survival figures (measured in months) for participants in the group. The values listed are 15.8, 22, 18.7, 12.5, 3.9, 20.8, and 11 months. It is worth noting that these figures appear to represent individual participant survival times rather than a single overall summary number, and the full set of individual results across all 35 participants was not reported in the structured data submitted to ClinicalTrials.gov. No secondary outcome measure results were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

  • NCT00424554 · results posted 29 June 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 40 people in total — 34 who received a chemotherapy medicine called temozolomide (TMZ) before surgery, and 6 who received no treatment before surgery. The trial was looking at whether temozolomide, given ahead of a brain tumour operation, had any effect on the levels of a particular protein in the tumour tissue called MGMT (a protein that can repair DNA damage in cancer cells). Researchers used a specially developed laboratory test to measure MGMT levels in tumour tissue removed during surgery. The reported data shows that in the temozolomide group, the average MGMT level measured in tumour tissue was 333.7 units (fmol/mg of proteins), compared with 105.1 units in the group that received no treatment before surgery. Regarding serious unwanted effects — specifically those rated "severe" or "life-threatening" on a standard medical grading scale — the reported data shows that 4 out of 34 participants in the temozolomide group experienced such effects, while none in the no-treatment group did. Importantly, no participants in either group stopped their treatment early because of unwanted effects. The reported data shows that two other planned measurements — temozolomide levels in the blood, brain fluid, and tumour tissue, and how those levels related to MGMT activity — could not be reported, because at the time the tumour samples were collected, the amount of temozolomide present was too low for the laboratory test to detect. These results were therefore 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 ↗

  • NCT00154375 · results posted 2 February 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 240 people with a type of brain tumour, split into two equal groups of 120. One group received a combination of two medicines — imatinib mesylate and hydroxyurea — while the other group received hydroxyurea alone. The trial's main goal was to measure "progression-free survival," which means the proportion of participants whose disease had not visibly worsened (or who had not died) over the course of the study. A standard set of brain tumour assessment guidelines called the MacDonald criteria were used to judge whether a participant's disease had progressed. The reported data shows that, for the primary measure of progression-free survival, 5.3% of participants in the combination group and 6.6% of participants in the hydroxyurea-alone group met this outcome at one time point, with both figures dropping to 2.1% at a later time point. Regarding serious or significant unwanted medical events (called adverse events), the reported data shows that 84 people in the combination group and 91 in the hydroxyurea-alone group experienced a death or serious adverse event of some kind. Severe or life-threatening adverse events were recorded in 76 and 77 participants respectively. Events that led to stopping study treatment were recorded in 6 participants in the combination group and 16 in the hydroxyurea-alone group. It should be noted that the majority of participants in both groups did not complete the full study — 113 in the combination group and 106 in the hydroxyurea-alone group did not finish. 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 ↗

  • NCT00021229 · results posted 9 April 2010

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called imatinib mesylate (also known as Gleevec) in children with certain brain tumours, particularly brainstem gliomas. A total of 85 participants were enrolled across three groups: 36 in a group receiving radiation therapy combined with imatinib mesylate (Stratum I), 33 receiving imatinib mesylate alone in one dosing group (Stratum IIA), and 16 in another dosing group without radiation (Stratum IIB). The trial had two phases — a first phase to find a safe dosing level, and a second phase to look further at the treatment, though only 14 participants from Stratum I moved into that second phase. The reported data shows that, during the first phase dose-finding period, 5 out of 23 participants in the radiation-plus-imatinib group experienced what are called "dose-limiting toxicities" — meaning unwanted reactions serious enough to affect how much of the drug could be given. Based on this, a maximum tolerated dose (the highest dose considered manageable) of 265 mg/m²/day was identified for that group. In the imatinib-alone group (Stratum IIA), 2 out of 20 participants had dose-limiting toxicities, giving a maximum tolerated dose of 465 mg/m²/day. In the third group (Stratum IIB), no dose-limiting toxicities were reported at any dose level tested, so no maximum tolerated dose was established for that group. The reported data also shows that for Stratum I, the median overall survival (meaning the midpoint time from starting treatment to death or last contact) was 324.5 days, and the highest recorded level of the drug in the blood on the first day of treatment ranged from 1.3 to 2.6 µg/ml across the groups. The median progression-free survival figure (the time before the disease worsened) 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 ↗

  • NCT00704808 · results posted 2 April 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people who had been newly diagnosed with a type of brain tumour called glioblastoma multiforme. All participants received a treatment called temozolomide (a chemotherapy medicine), given both at the same time as radiotherapy and then on its own afterwards, following surgery. The trial was designed to measure how long patients went without their tumour growing or spreading — a period known as "progression-free survival." The reported data shows that 49 of the 180 participants completed the study, while 131 did not complete it (the reasons for not completing were not detailed in the data provided). The main result reported was the **median progression-free survival** — meaning the point in time by which half of the participants had experienced their tumour growing or spreading again. According to the results reported on ClinicalTrials.gov, that figure was **9.57 months**. No secondary outcome measure results were included in the submitted data, so those figures cannot be reported here. It is worth noting that this trial involved only one group of participants, meaning there was no comparison group, so the reported number reflects only what was observed in people receiving temozolomide in this particular study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

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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.