Reported trial results for Ovarian Cancer
Every Ovarian 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.
94 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT05715216 · results posted 8 July 2026
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — nivolumab and etigilimab — in people with a type of ovarian cancer called platinum-resistant clear cell ovarian cancer. This means the cancer had stopped responding to a common chemotherapy treatment containing platinum. A total of 23 people started the trial, and 19 completed it, with 4 not completing it for reasons not detailed here. The trial was measuring how many participants had their tumours shrink or disappear (called the objective response rate), how long any tumour shrinkage lasted, and what unwanted reactions to the treatment were recorded. The reported data shows that 15% of participants had their tumour shrink or disappear (this is the objective response rate — the proportion of people whose cancer visibly reduced). A separate figure of 30% was also reported in relation to this measure, though the data as submitted does not make fully clear what this second figure specifically refers to — it may relate to a broader measure of benefit including stable disease, but this was not explicitly labelled in the submitted data. For how long tumour responses lasted, the reported data shows an average (median) duration of 8.6 months from the start of treatment until the disease was recorded as getting worse again. Regarding unwanted reactions, the reported data shows that 47.8% of participants experienced a reaction that was tracked under the toxicity measure, and 0% were recorded against a second category within that measure — however, the specific definitions of these two categories were not included in the submitted data, so they cannot be described in further detail here. The data was not reported in a way that allows a full breakdown of what types of reactions occurred or how serious they were. 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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NCT06390995 · results posted 16 June 2026
According to the results reported on ClinicalTrials.gov, this trial tested an experimental treatment called TAK-853, given at a dose of 6 mg/kg, in people with cancer. The trial had two phases. Phase 1 — the safety lead-in phase — enrolled 3 participants, and all 3 completed that phase. Phase 2 enrolled 25 participants, none of whom had completed the study by the time results were submitted. The main focus of Phase 1 was to look at how participants responded to the treatment in terms of unwanted medical events (called adverse events), particularly in the first treatment cycle. The reported data shows that, among the 3 Phase 1 participants, none experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious enough reaction in the first cycle that would signal the dose was too high by the trial's pre-set rules. All 3 participants experienced at least one treatment-emergent adverse event (meaning any unwanted medical occurrence that happened after starting the study drug). Of those 3 participants, 2 had adverse events rated as severe or higher (Grade 3 or above on a standard scale), and 2 experienced what were classified as serious adverse events. One participant stopped taking the study drug due to an adverse event, and none experienced an interruption to their infusion due to an adverse event. No outcome data for the 25 Phase 2 participants was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04729387 · results posted 4 June 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04729387) enrolled 358 people with cancer — 180 in the group receiving a combination of two medicines called alpelisib and olaparib, and 178 in a comparison group receiving one of two standard chemotherapy medicines (paclitaxel or pegylated liposomal doxorubicin, sometimes called PLD). The main thing the trial was measuring was "progression-free survival" — that is, how long participants went before their cancer showed signs of growing or spreading, or before they passed away. The reported data shows that, for the primary measure, the median time before disease progression or death was 3.6 months in the alpelisib-plus-olaparib group and 3.9 months in the chemotherapy group. ("Median" simply means the middle value — half the participants reached that point sooner, half later.) For secondary measures, the reported data shows that about 15.6% of people in the alpelisib-plus-olaparib group and 13.5% in the chemotherapy group had their tumour shrink meaningfully (known as the overall response rate). A slightly broader measure — counting people whose disease also stayed stable for at least 24 weeks — came to 21.1% versus 19.1% respectively. Among those whose tumours did respond, the reported time that response lasted was a median of 7.36 months in the alpelisib-plus-olaparib group and 5.5 months in the chemotherapy group. Overall survival data and time-to-response figures were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05041257 · results posted 9 January 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 79 participants, all of whom received at least one dose of the study drug, mirvetuximab soravtansine. The trial was a single-group study, meaning there was no comparison group — everyone received the same treatment. The main thing the trial set out to measure was the "objective response rate," which refers to the proportion of participants whose tumours shrank by a meaningful amount (either disappearing completely or reducing in size by at least 30%) based on standard imaging criteria. The reported data shows that 51.9% of participants met the criteria for a tumour response (either a complete or partial shrinkage) as assessed by their treating doctor. Among those who did respond, the reported data shows the average length of time that response lasted was approximately 8.25 months. For a separate blood marker commonly used in this type of cancer (called CA-125), the reported data shows that 74.5% of participants had at least a 50% reduction in their levels, sustained for at least 28 days. The trial also reported that the median time before the disease worsened or death occurred (known as progression-free survival) was approximately 6.93 months, and the median overall survival — meaning the midpoint for how long participants lived from their first dose — was reported as approximately 27.17 months. Regarding unwanted medical events during the study, the reported data shows that 78 out of 79 participants experienced at least one treatment-emergent adverse event (that is, a medical occurrence that happened after starting the study drug). The data does not break down the nature or severity of those events in this summary. It is also worth noting that none of the 79 participants were recorded as having "completed" the study in the formal sense, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04106492 · results posted 14 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04106492) tested an experimental treatment called SQ3370, which combines two components — SQL70 and SQP33 — that are injected directly into tumours. The trial involved people with solid tumours, including a type called soft tissue sarcoma (a cancer that forms in soft tissues like muscle or fat). A total of 54 participants took part across 15 groups, with each group receiving a different dose or dosing schedule. The trial was designed in two stages: an early phase to find a recommended dose, and a later phase to look at how tumours responded to that dose. The reported data shows that the recommended dose identified in the first stage was 1,250 mg per square metre of body surface area per cycle, and this was the same whether the smaller (10 mL) or larger (20 mL) volume of SQL70 was used. In the second stage, the trial measured how many participants had their tumours shrink or disappear — this is called the "objective response rate." Across the four groups in this stage, the reported data shows that out of a combined total of 15 participants, 2 individuals had an objective response (one tumour response was recorded in one group of 2 participants, and one in another group of 6 participants). The remaining groups recorded zero responses. No data was reported for some details that were not 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 ↗ · Linked publication on PubMed ↗
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NCT05370521 · results posted 9 October 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called tildacerfont in people with polycystic ovary syndrome (PCOS) who had elevated levels of a hormone called DHEAS, which is produced by the adrenal glands. A total of 27 people took part — 17 in the tildacerfont group and 10 in the placebo (dummy treatment) group. Of these, 16 and 9 respectively completed the trial, with one person in each group not finishing. The reported data shows that the main thing being measured was the change in DHEAS levels from the start of the trial to the end. In the tildacerfont group, DHEAS levels changed by an average of −22.93 µg/dL (meaning they went down by that amount on average), while in the placebo group the average change was −7.56 µg/dL. As secondary measurements, the trial also looked at how many participants had a reduction in DHEAS of 30% or more from their starting level — this was reported as 1 person in the tildacerfont group and 1 person in the placebo group. When looking at how many participants had DHEAS levels return to within the normal range, the reported data shows 8 out of 17 in the tildacerfont group and 6 out of 10 in the placebo group. The trial also recorded the number of people who experienced side effects (called treatment-emergent adverse events): 13 out of 17 in the tildacerfont group and 9 out of 10 in the placebo group had at least one such event 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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NCT03660826 · results posted 23 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03660826) enrolled 288 people across seven treatment groups, with between 40 and 43 participants in each group. The trial was testing several different drug combinations — including cediranib maleate, olaparib, capivasertib, and durvalumab — used alone or together. The main thing researchers were tracking was **progression-free survival**: how long participants went before their disease got worse or they passed away. The reported data shows that the median progression-free survival (that is, the midpoint time before disease worsening or death) ranged from 2.0 months in the olaparib-alone group up to 6.0 months in the cediranib plus durvalumab group. For overall survival (time from enrolment until death from any cause), the reported median figures ranged from 12.4 months to 22.6 months across the seven groups, with the cediranib plus durvalumab group recording the highest figure of 22.6 months. When looking at tumour response — meaning the number of participants whose tumours shrank or disappeared — the reported numbers ranged from 4 participants (olaparib alone) to 16 participants (cediranib plus durvalumab) across the groups. The reported data also shows that the number of participants who experienced at least one serious side effect (graded as "grade 3 or above," meaning a more significant medical event) ranged from 19 to 31 people per group. No results were reported for the planned analyses of DNA repair gene mutations or markers of blood vessel growth. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02489903 · results posted 17 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02489903) enrolled people with cancer who had already received prior treatment. A total of 118 people entered the screening phase in one part of the study, and a further 21 in a later part. Of those, 94 went on to receive a combination of RRx-001 (an experimental drug) plus a standard chemotherapy duo called a "platinum doublet," while 11 received RRx-001 combined with platinum chemotherapy followed by more RRx-001, and 2 received a treatment chosen by their doctor (the "investigator's choice" comparison group). The trial was primarily measuring how long participants lived overall, and also tracked whether tumours shrank or stopped growing. The reported data shows that, for overall survival — meaning the time from joining the trial until death or last check-in — the median (the midpoint figure, where half of participants lived longer and half shorter) was 6.85 months for the main RRx-001 plus chemotherapy group, 7.6 months for the RRx-001 plus platinum then RRx-001 group, and 7.5 months for the investigator's choice group. For the secondary measure of how long disease stayed stable or improved before worsening (progression-free survival), the reported figures were 5.87 months, 6.50 months, and 12 months respectively. The reported data also shows that, in the main RRx-001 plus chemotherapy group, 32 participants had their tumour shrink or disappear (overall response), and 42 participants had their disease either shrink, disappear, or remain stable (disease control). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02601950 · results posted 11 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02601950) looked at a drug called tazemetostat across eight separate groups of participants, each with a different type of rare cancer — including rhabdoid tumours, synovial sarcoma, renal medullary carcinoma (RMC), epithelioid sarcoma (ES), chordoma, and other related tumour types. In total, 267 people took part across all groups. The trial was measuring things like how many participants' tumours shrank or disappeared (called the "objective response rate"), how long that response lasted, and how long participants went without their cancer growing or spreading (called "progression-free survival"). For one smaller group testing a higher dose, the trial tracked the number of participants who experienced medical events during treatment. The reported data shows that the proportion of participants whose tumours shrank or disappeared varied by cancer type: roughly 9% in the rhabdoid tumour group, 9% in the other INI1-negative tumour group, 0% in the RMC group, 16% in the epithelioid sarcoma group, 16% in the epithelioid sarcoma paired biopsy group, and about 6% in the chordoma group. For the synovial sarcoma group, the primary measure was different — the proportion still free from cancer progression at 16 weeks was reported as approximately 15%. Among those participants who did show a tumour response, the reported data shows the length of that response ranged from around 29 weeks in the rhabdoid tumour group up to approximately 152 weeks in one of the epithelioid sarcoma groups. The median time before cancer progressed or participants died ranged from about 7 weeks in some groups to approximately 40 weeks in the chordoma group. For the small higher-dose group (7 participants), 7 experienced treatment-emergent adverse events (medical events that occurred or worsened during treatment) and 2 experienced serious adverse events, though the data as reported does not break these down 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 ↗
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NCT04406623 · results posted 30 January 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called SL-172154 in 27 people with cancer. Participants were split into five groups, each receiving a different dose of the drug — 0.1, 0.3, 1.0, 3.0, or 10.0 milligrams per kilogram of body weight. All 27 participants across the five groups completed the study. The trial was primarily looking at what side effects or reactions occurred at each dose level, and whether any dose caused a reaction serious enough to limit how high the dose could go (called a "dose-limiting toxicity"). It also looked at how the drug behaved in the body, and whether there were any early signs of the drug affecting tumours. The reported data shows that across all five dose groups, every participant who started the study experienced at least one treatment-related adverse event (an unwanted reaction that emerged during treatment). When it came to dose-limiting toxicities — serious reactions that would signal a dose was too high — the data shows that none occurred in the four lower-dose groups, while one out of five participants in the highest dose group (10.0 mg/kg) experienced one. The reported data also shows that no participant in any dose group had a measurable reduction in their tumour according to standard criteria (known as an "objective response"). For the secondary outcome looking at the recommended dose for future studies, the data shows a figure of 3.0 mg/kg was put forward. The trial also measured blood levels of the drug, with the highest dose group showing the largest peak drug concentration in the bloodstream. The reported data shows that some participants also developed antibodies against the drug (known as anti-drug antibodies), with numbers varying across the dose groups, though the full breakdown of the different antibody categories was not entirely clear from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03994653 · results posted 20 January 2025
According to the results reported on ClinicalTrials.gov, this trial — called CLOCS — enrolled 306 people who had been diagnosed with ovarian cancer (referred to as "Cases") and 657 people without ovarian cancer ("Controls"). The trial was looking at whether shopping purchase records, specifically how often people bought pain relief and indigestion medications, might differ between these two groups in the period leading up to a cancer diagnosis. The reported data shows three sets of measurements comparing the average number of relevant items purchased by each group. In the first measurement, the Cases group purchased an average of 3.2 items compared to 2.0 items in the Controls group. In the second measurement, those figures were 5.9 items for Cases and 4.3 items for Controls. In the third measurement, the reported averages were 11.4 items for Cases and 8.5 items for Controls. It is worth noting that not all participants completed the study — 153 of the 306 Cases and 120 of the 657 Controls were recorded as having completed it. For the secondary outcome, which aimed to define a specific purchase level that might act as an "alert" signal for cancer symptoms, 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 ↗
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NCT02312245 · results posted 5 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants across four treatment groups. Each group received a different chemotherapy drug — paclitaxel (3 participants), gemcitabine hydrochloride (1 participant), liposomal doxorubicin (0 participants), or topotecan hydrochloride (9 participants) — with the drug chosen based on testing done on a laboratory-grown tumour model (called an "avatar") derived from each patient's own cancer. No participants completed the study as planned; all 13 did not complete it. Results for Arm C (liposomal doxorubicin) were not reported in the outcomes, as no participants were enrolled in that group. The reported data shows that, for the primary measure — the proportion of participants whose tumour shrank or disappeared — zero out of the evaluable participants in each of the three reported groups (paclitaxel, gemcitabine, and topotecan) met that threshold. For secondary measures, the reported data shows that 1 participant in the paclitaxel group, 1 in the gemcitabine group, and 4 in the topotecan group experienced serious side effects graded 3 or above (meaning more severe in intensity on a standard scale). Regarding how long participants lived overall, the reported median figures were 7.9 months for the paclitaxel group, 8.7 months for the gemcitabine group, and 9.2 months for the topotecan group. The reported data also shows the time participants went without their disease getting worse was 7.9 months, 8.7 months, and 3.0 months for those three groups respectively. It is worth noting that the very small number of participants — particularly just one person in the gemcitabine group and no one in the liposomal doxorubicin group — means the reported figures for those arms are based on extremely limited data. An exploratory analysis looking at a laboratory marker called an "enriched avatar response signature" was listed as a planned outcome, but no results data was reported for it 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.
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NCT03113487 · results posted 8 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03113487) enrolled 29 participants, all of whom received a combination of two treatments: p53MVA (a type of vaccine designed to target a protein called p53, which is often abnormal in cancer cells) and Pembrolizumab (an immunotherapy drug). Twenty-eight of the 29 participants completed the study. The trial was primarily measuring how many participants' tumours shrank or disappeared in response to the combination treatment, and also tracked how long participants lived without their cancer getting worse, how long they survived overall, and the proportion who experienced any meaningful benefit from treatment. The reported data shows that out of the 29 participants, 3 achieved either a complete response (tumours fully disappeared) or a partial response (tumours shrank by at least half), as measured by a standardised set of imaging criteria. For the secondary measures, the reported data shows a median progression-free survival — that is, the midpoint estimate of how long participants went before their cancer worsened or they died — of 1.8 months. The median overall survival was reported as 15.1 months. The reported clinical benefit rate — meaning the percentage of participants who had tumours shrink, disappear, or remain stable for more than six months — was approximately 21.4%. 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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NCT02601937 · results posted 3 October 2024
According to the results reported on ClinicalTrials.gov, this trial tested a medicine called tazemetostat in children and young people with cancer. The trial ran in two parts: a dose-escalation phase, where researchers gradually increased the dose across seven groups to find a safe starting dose for future studies (a total of 46 participants), and a dose-expansion phase, where four further groups — totalling 63 participants — received the medicine at set doses to look at how tumours responded. In all, 109 participants took part across the eleven groups. The reported data shows that in the dose-escalation phase, only 2 out of the 46 participants had a "dose-limiting toxicity" — a side effect serious enough, within the first month, to affect how the dose was set. Based on this, the trial reported a Recommended Phase 2 Dose (the dose suggested for the next stage of research) of 1,200 mg/m² twice daily for most tumour types, and 520 mg/m² twice daily for one specific tumour type. For tumour response in the expansion phase, the reported data shows that the percentage of participants whose tumours shrank by a meaningful amount (called the Overall Response Rate) was 26.3% in Cohort 1, 0% in Cohort 2, 16.7% in Cohort 3, and 16.7% in Cohort 4. The reported median time before the disease progressed or participants died (Progression-Free Survival) ranged from 7.7 weeks (Cohort 2) to 28.3 weeks (Cohort 4), and the reported median overall survival ranged from 14.1 weeks (Cohort 2) to 103.1 weeks (Cohort 4). 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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NCT04672460 · results posted 25 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04672460) enrolled a total of 73 participants across two groups (35 in one sequence and 38 in the other). The trial ran across several phases and was designed to compare how the body absorbs a drug called talazoparib when taken as two different capsule forms — an existing commercial capsule and a newer soft gel capsule — and to look at whether taking the soft gel capsule with food (fed) versus without food (fasted) made a difference. The trial measured levels of talazoparib in participants' blood over time. The reported data shows two key blood-level measurements for each comparison. The first is the total amount of drug in the blood over 24 hours (sometimes called "drug exposure"), and the second is the highest level the drug reached in the blood. For the fasted comparison, the total 24-hour exposure was reported as 178.7 ng·hr/mL for the commercial capsule and 173.0 ng·hr/mL for the soft gel capsule. The peak blood level was reported as 14.95 ng/mL for the commercial capsule and 19.19 ng/mL for the soft gel capsule. For the food-effect comparison (both using the soft gel capsule), the total 24-hour exposure was 173.0 ng·hr/mL when fasted and 151.3 ng·hr/mL when fed, while the peak blood level was 19.19 ng/mL when fasted and 11.36 ng/mL when fed. Secondary measurements included how quickly the body cleared the drug and the time it took to reach peak blood levels, which were also reported across the three treatment conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03493464 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03493464) enrolled 14 participants in a single treatment group, and 13 of them completed the study (one did not complete it). The trial was measuring two main things: how well an imaging agent called BR55 showed up on ultrasound scans of participants, and how many participants experienced any unwanted health events (known as adverse events) after receiving the agent. The reported data shows that, of the participants whose scans were assessed, 5 showed no detectable imaging signal from BR55, 6 showed a weak signal that was considered possibly stationary (meaning it appeared to stay in one spot), and 3 showed a strong, well-defined signal that was considered definitely stationary. Regarding adverse events, the reported data shows that 3 out of the participants who received the imaging agent experienced an adverse event of some kind. No further detail about the nature of those events was included in the submitted results data. It is worth noting that this was a small, single-group trial with no comparison group, and the results cover only what was observed in these 14 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04296890 · results posted 7 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people, all of whom received a drug called mirvetuximab soravtansine. The trial was measuring how the drug performed in participants with a specific type of ovarian cancer. The main thing researchers were tracking was the "objective response rate" — that is, the proportion of participants whose tumours shrank or disappeared by a defined amount during treatment. A number of secondary measures were also tracked, including how long any tumour shrinkage lasted, how long before the disease progressed, and how long participants survived overall. The reported data shows that 32.4% of participants (roughly 1 in 3) had their tumours shrink or disappear to a degree that met the trial's definition of a response. Among those who did respond, the reported duration of that response was a median of approximately 6.93 months (median means half lasted longer, half shorter). For a blood marker of ovarian cancer called CA-125, 46.5% of participants showed a meaningful reduction. The reported median progression-free survival — the time before the disease was recorded as worsening — was approximately 4.27 months, and the reported median overall survival was approximately 15.0 months. Regarding unwanted medical events during the trial, the reported data shows that 105 out of 106 participants experienced at least one treatment-emergent adverse event (an unintended medical occurrence that happened during or shortly after treatment); the nature and severity of those events are detailed separately in the trial's adverse events section 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04209855 · results posted 1 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04209855) enrolled 453 people with ovarian cancer — 227 assigned to receive a drug called mirvetuximab soravtansine and 226 assigned to receive a chemotherapy chosen by their doctor (referred to as "Investigator's Choice" chemotherapy). The trial's main goal was to measure **progression-free survival** — that is, how long participants went without their disease getting worse or dying. Secondary goals included looking at overall survival (how long participants lived), how many people's tumours shrank, how long those responses lasted, and participants' quality of life relating to abdominal and gut symptoms. The reported data shows that, for the main measure, the mirvetuximab soravtansine group had a median progression-free survival of 5.59 months, compared with 3.98 months in the chemotherapy group. (Median means half the participants in each group reached that point before the disease progressed or they died, and half did not.) For overall survival, the reported median figures were 16.85 months in the mirvetuximab soravtansine group and 13.34 months in the chemotherapy group. When looking at tumour shrinkage, 41.9% of participants in the mirvetuximab soravtansine group showed a confirmed response (tumour shrinkage meeting set criteria), compared with 15.9% in the chemotherapy group. Among those who did respond, the reported median duration of that response was 6.93 months versus 4.44 months. Regarding quality of life, 34 participants in the mirvetuximab soravtansine group and 23 in the chemotherapy group recorded at least a 15-point improvement in abdominal and gut symptom scores at around weeks 8–9. The reported data also shows that 211 out of 218 participants who received at least one dose of mirvetuximab soravtansine experienced a treatment-emergent adverse event (an unwanted medical occurrence during the study period), compared with 194 out of 207 in the chemotherapy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04408599 · results posted 25 July 2024
According to the results reported on ClinicalTrials.gov, this trial tested a drug called NC410 in 46 people with solid tumour cancers. Participants were divided into seven groups, each receiving a different dose of NC410 — ranging from 3 mg up to 200 mg — to help researchers understand how the drug behaved at different dose levels. The trial was primarily looking at how many participants experienced side effects or unwanted health events during treatment (called "treatment-emergent adverse events"). It also tracked measures related to how participants' tumours responded to the treatment. The reported data shows that across all seven dose groups, nearly every participant experienced at least one treatment-emergent adverse event — with the numbers ranging from 3 out of 3 participants in the lowest dose group, up to 10 out of 10 in the 60 mg group. Regarding tumour response, the reported data shows that in every dose group, zero participants had their tumours shrink enough to meet the criteria for a full or partial response. For "disease control" — which also includes participants whose tumours stayed stable — the reported data shows that only 1 participant in most groups, and 3 participants in the 6 mg group, met this measure. The median time until the disease progressed (or the participant passed away) was reported as being between approximately 1.3 and 3.6 months across the different dose groups. No duration-of-response data was reported, as no participants achieved a qualifying tumour response. Blood level measurements of NC410 (how much of the drug was detected in the bloodstream) were not reported for the two lowest dose groups, but were reported for the remaining groups and appeared to increase with higher doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02157974 · results posted 4 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 92 participants across five groups: 24 people without polycystic ovary syndrome (PCOS) who acted as a comparison group (controls), and 68 people with PCOS split into four sub-groups based on their medication status — those on no medication (42 people), those on no medication but also receiving a drug called Byetta (10 people), those taking the oral contraceptive pill (10 people), and those taking Metformin (6 people). Three participants in the medication-naive PCOS group did not complete the study; all others finished. The trial was measuring how the liver handles glucose (sugar) and fat in people with PCOS compared to those without it, using a range of specialised scans and tracers. The reported data shows the following figures for the main outcome — the rate at which the liver releases glucose into the blood (measured in mg/kg/min): 1.85 for controls, 1.46 for medication-naive PCOS, 1.54 for the Byetta group, 1.88 for the oral contraceptive group, and 1.57 for the Metformin group. For liver fat content (where above 5% is considered elevated), the reported percentages were 4.1% for controls, 7.6% for medication-naive PCOS, 6.9% for the Byetta group, 6.8% for the oral contraceptive group, and 13.3% for the Metformin group. The rate at which the body broke down fat (lipolysis) was reported as 0.54 for controls, 0.49 for medication-naive PCOS, 0.49 for Byetta, 0.78 for the oral contraceptive group, and 0.65 for the Metformin group. A measure of new fat production in the liver was reported as 9.3, 6.6, 7.9, 18.2, and 19.4 for the five groups respectively. Results for liver phosphate concentrations were also reported, though the data as submitted covers only four of the five groups and does not include the medication-naive PCOS group for that particular measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02326064 · results posted 15 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 221 women who had been found to have an ovarian tumour (a growth on the ovary). Of these, 209 women had a tumour that was classed as benign (non-cancerous), and 12 had a tumour classed as borderline or malignant (potentially or actively cancerous). All 221 women who started the trial also completed it. The trial was measuring two substances found in the blood — called CA125 and HE4 — which are sometimes referred to as "tumour markers." The study looked at the levels of these markers across the two groups of women. The reported data shows that for the CA125 marker (where a reading above 35 U/mL is considered abnormal), 189 women in the benign tumour group and 4 women in the borderline/malignant tumour group returned a result. For the HE4 marker (where the cut-off for an abnormal reading differs depending on whether a woman has been through menopause — above 70 pmol/L for pre-menopausal women and above 140 pmol/L for post-menopausal women), 191 women in the benign group and 6 women in the borderline/malignant group returned a result. It should be noted that the data as submitted does not break down how many of those results fell above or below the abnormal thresholds, so that level of 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 ↗
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NCT03151005 · results posted 4 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03151005) enrolled 70 participants in total, split evenly into two groups of 35 — one group received a combination of metformin and a GLP-1 receptor agonist (a type of medication that affects blood sugar and appetite), and the other received a combination of metformin and an oral contraceptive pill. The trial was measuring several things related to reproductive hormones, body weight, liver function, and blood pressure. Of the 70 people who started, 60 completed the study — 30 in each group — and 5 people in each group did not finish. The reported data shows the following figures at the end of the trial. For the primary measure — a reproductive hormone called LH (luteinising hormone, which plays a role in the menstrual cycle) — the metformin–GLP-1 group recorded an average of 5.52 mIU/ml, and the metformin–oral contraceptive group recorded 5.33 mIU/ml. For body mass index (BMI, a measure comparing weight to height), the reported averages were 26.26 kg/m² and 27.12 kg/m² respectively. A liver enzyme called alanine transaminase (a marker sometimes used to check liver health) averaged 39.09 IU/L in the first group and 36.73 IU/L in the second. Systolic blood pressure (the top number in a blood pressure reading) was reported as 122.83 mmHg and 122.40 mmHg. Finally, testosterone levels averaged 1.82 nmol/L in the metformin–GLP-1 group and 2.14 nmol/L in the metformin–oral contraceptive group. No further detail about how these numbers changed over time, or any comparison between groups, was 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 ↗
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NCT04034927 · results posted 13 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04034927) enrolled 61 people in total — 30 in a group receiving olaparib alone, and 31 in a group receiving olaparib combined with tremelimumab. The trial was looking at two main things: how many participants experienced their cancer growing or spreading (called "progression") or died during the study period, and how many people in the combination group were unable to complete at least three rounds of treatment due to serious treatment-related side effects (called dose-limiting toxicities, or DLTs). It also tracked a number of secondary measures, including how many participants showed a measurable shrinkage in their cancer, how many died over the course of the study, and how many experienced serious side effects. The reported data shows that, for the primary measure of disease progression or death, 24 out of 30 participants in the olaparib-alone group and 23 out of 31 in the combination group reached that point during the study. For the DLT safety check, 0 participants in the olaparib-alone group and 6 participants in the combination group were recorded as experiencing a dose-limiting toxicity. Regarding the secondary outcomes, the reported data shows that 11 participants in the olaparib-alone group and 9 in the combination group had a measurable reduction in their cancer (either a complete or partial response). The number of deaths recorded was 9 in the olaparib-alone group and 11 in the combination group. For serious side effects graded as severe or higher (Grade 3 or above), 15 participants in the olaparib-alone group and 20 in the combination group were reported to have experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02734004 · results posted 13 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02734004) enrolled a total of 262 participants across seven groups, covering four cancer types: small cell lung cancer, breast cancer, ovarian cancer, and gastric cancer. The trial was run in two stages. In the first stage, the main thing being measured was how many participants had their disease controlled (meaning it had either shrunk or stayed stable) at 12 weeks into treatment. In the second stage, the focus shifted to ovarian cancer specifically, looking at how many participants showed a measurable response to treatment and how many had their disease controlled at 24 weeks. It is worth noting that the data shows zero participants recorded as having "completed" the study across all groups — the results do not explain this further, and no additional detail was reported on ClinicalTrials.gov for that figure. The reported data shows the following results for the first stage at 12 weeks: approximately 28.9% of participants in the small cell lung cancer group, 80.0% in the breast cancer group, 81.3% in the ovarian cancer group, and 25.6% in the gastric cancer group had their disease controlled at that point. At the later 28-week mark, those figures were reported as 5.3%, 50.0%, 65.6%, and 7.7% respectively for those same groups. For the second stage, the reported data shows that 92.2% of participants in the ovarian cancer expansion group had a measurable response to treatment (meaning their disease appeared to shrink or disappear based on scans). At 24 weeks, 88.2% of that same expansion group had their disease controlled, compared with 74.2% in the ovarian cancer "triplet" group and 28.1% in the "doublet" group. By 56 weeks, those disease-control figures had fallen to 41.2%, 38.7%, and 9.4% for the expansion, triplet, and doublet groups respectively. These numbers reflect what researchers measured and recorded at specific points in time during the trial, using standard imaging-based criteria to assess each participant's disease. The reported data does not include information about what treatments were given in each group or further context about the participant characteristics, so these figures should be read with that limitation in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02101775 · results posted 8 September 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 124 people in total with recurrent, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Participants were split into three groups: 65 people received the experimental drug AZD1775 (a WEE1 inhibitor) combined with the chemotherapy drug gemcitabine; 34 people received a placebo combined with gemcitabine; and 25 people took part in a separate exploratory group also receiving AZD1775 with gemcitabine. The trial was primarily measuring how long people went without their cancer growing or spreading (called "progression-free survival"), and also looked at a number of secondary measures including overall survival, tumour response, and a blood marker called CA-125. The reported data shows that the median time before cancer progression was 4.6 months in the AZD1775 plus gemcitabine group, compared to 3.0 months in the placebo plus gemcitabine group, and 5.3 months in the exploratory group. For overall survival, the reported median figures were 11.4 months, 7.2 months, and 13.0 months for the three groups respectively. Looking at tumour response (how many participants' tumours shrank by a meaningful amount according to standard imaging criteria), 14 participants in the main AZD1775 group, 2 in the placebo group, and 3 in the exploratory group met the threshold for an objective response. For the CA-125 blood marker measure, 14, 3, and 4 participants across the three groups respectively showed at least a 50% reduction in that marker. The reported data also shows that 38 out of 65 participants in the main AZD1775 group, 10 out of 34 in the placebo group, and 18 out of 25 in the exploratory group experienced serious (grade 3 or 4) side effects considered related to the study treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03302156 · results posted 9 August 2023
According to the results reported on ClinicalTrials.gov, this trial looked at whether a special type of imaging scan — called a PSMA PET/MR scan — could accurately detect ovarian cancer. The scan uses a radioactive tracer to highlight a protein called PSMA, which can appear on some cancer cells. A total of 15 people started the trial across two groups: 2 healthy volunteers and 13 cancer patients (with 1 patient not completing the study, leaving 12 in the final analysis). A third planned group — a dosimetry group, which would have measured radiation exposure in more detail — had no participants enrolled. The reported data shows results for one of the secondary outcomes: how much of the tracer was taken up in different tissues, measured using a value called SUVmax (a number that reflects how much of the tracer collected in a particular area — higher numbers mean more tracer). In normal tissues, the reported SUVmax values ranged from around 1.5 to 12.1 in healthy volunteers and from approximately 1.7 to 10.0 in the patient group, across several different body areas. In cancer tissue, the reported data shows an SUVmax value of 10.5 was recorded in the patient group. For the trial's primary outcome — how often the scan and a laboratory tissue test agreed or disagreed on whether disease was present — no numerical results were reported in the submitted data. Similarly, no results were reported for the radiation dosimetry outcome or the sensitivity and specificity outcome. It is worth noting that only one patient was confirmed to have ovarian cancer with detectable PSMA uptake, which means the dataset is very small and the reported figures reflect a very limited number of cases. 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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NCT03330405 · results posted 12 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03330405) tested a combination of two medicines — avelumab and talazoparib — across several groups of people with different types of advanced cancer, including lung cancer, breast cancer, ovarian cancer, bladder cancer, and prostate cancer. A total of 223 people took part across all groups: 12 in an early safety-testing phase (Phase 1b) and 211 across the later Phase 2 groups. The trial was measuring, among other things, how often tumours shrank or disappeared (called an "objective response"), and what kinds of unwanted medical events (called adverse events) participants experienced while on treatment. The reported data shows that in the early Phase 1b portion, 3 out of 12 participants experienced what are called "dose-limiting toxicities" — that is, serious unwanted effects serious enough to affect how much of the medicine could be given. In Phase 2, the percentage of participants whose tumours showed a confirmed response varied considerably depending on the cancer group: for example, the reported figures ranged from 0% in the BRCA/ATM-mutated prostate cancer subgroup, up to 63.6% in the ovarian cancer group with a BRCA gene mutation. For the two main prostate cancer groups, the reported response figures were 0% and 11.1% respectively. Regarding unwanted medical events during treatment, the reported data shows that all 12 Phase 1b participants and 207 out of 211 Phase 2 participants experienced at least one treatment-emergent adverse event. Of those, 9 Phase 1b participants and 156 Phase 2 participants experienced events graded as severe or worse, and serious adverse events were reported in 1 Phase 1b participant and 75 Phase 2 participants. No participants were recorded as having completed the study, though the data does not explain further what this means in context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03642132 · results posted 6 April 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 79 participants across three treatment groups. The first group (32 people) received chemotherapy combined with a drug called avelumab, then moved on to avelumab plus talazoparib. The second group (13 people) received chemotherapy alone, then talazoparib on its own. The third group (34 people) received chemotherapy combined with bevacizumab, then continued on bevacizumab. The trial was measuring, among other things, how many participants experienced unwanted medical events (called adverse events) during treatment, how the body absorbed and processed avelumab (a type of drug level monitoring), and whether participants developed antibodies against avelumab. The reported data shows that during the treatment period, 29 out of 32 participants in the chemotherapy-plus-avelumab group, all 13 participants in the chemotherapy-only group, and all 34 participants in the bevacizumab group experienced at least one adverse event — that is, an unwanted medical occurrence of any kind noted during the study. It is important to note that these events are not necessarily caused by the treatment; they simply occurred during the time participants were on the study. Regarding antibodies against avelumab, 17 participants were recorded as "never positive" and 12 as "ever positive" for these antibodies, though the full meaning of these categories was not further detailed in the submitted data. The reported data also shows the levels of avelumab measured in participants' blood at various time points. During the chemotherapy period, pre-dose drug levels ranged from 0.000 to 10.00 micrograms per millilitre (mcg/mL), while during the maintenance period they ranged from 3.47 to 41.60 mcg/mL. The peak drug levels (the highest concentration reached in the blood) ranged from 218.0 to 253.0 mcg/mL during chemotherapy and from 219.0 to 279.0 mcg/mL during maintenance. No primary outcome measure data appeared to be included in the submitted results, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00849667 · results posted 30 December 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled around 1,100 people in total across three groups. Approximately 370 people received a lower dose of the study drug farletuzumab (1.25 mg/kg) combined with standard chemotherapy (taxane and carboplatin), around 366 received a higher dose of farletuzumab (2.5 mg/kg) with the same chemotherapy, and roughly 364 received a dummy (placebo) treatment alongside the same chemotherapy. The trial's main goal was to measure how long it took for participants' cancer to grow or spread again — known as "progression-free survival" — and several secondary measures were also tracked, including how long participants lived overall. The reported data shows that for the primary measure — the time until the cancer progressed or death occurred — the lower-dose farletuzumab group recorded a median (the midpoint value for the group) of 9.5 months, the higher-dose group recorded 9.7 months, and the placebo group recorded 9.0 months. For overall survival (time from the start of the trial until death from any cause), the reported figures were 28.7 months, 32.1 months, and 29.1 months for the lower-dose, higher-dose, and placebo groups respectively. A blood marker for cancer called CA-125 was also used to track progression, and the reported times were 13.2, 18.1, and 12.0 months across the same three groups. When looking at the proportion of participants whose tumours shrank by a meaningful amount, the reported figures were approximately 57.6%, 58.2%, and 55.8% for the lower-dose, higher-dose, and placebo groups respectively. The proportion of participants whose second period of remission lasted longer than their first was reported as 4.0%, 6.5%, and 4.5% across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03382574 · results posted 14 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03382574) involved two groups of participants: one group received the drug denosumab followed by a risk-reducing surgical procedure to remove the fallopian tubes and ovaries, while the other group had the same surgery without the drug. The trial was designed to measure changes in cell activity in the fallopian tubes, ovaries, and uterine lining — specifically looking at a marker called Ki67, which indicates how quickly cells are dividing, as well as a range of other biological markers in tissue and blood samples. The reported data shows that zero participants were recorded as having started, completed, or left the study early. This means no participant data was entered into the results section on ClinicalTrials.gov. For every outcome the trial set out to measure — including the main measure of cell division activity in the fallopian tube, as well as all secondary measures such as other tissue markers, gene activity, and blood hormone levels — no numerical results were reported. The data for all of these outcomes 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.
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NCT03106987 · results posted 19 April 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03106987) enrolled 220 people in total across four groups. Participants had either a BRCA1/2 gene mutation (positive) or did not (negative), and within each of those groups they were randomly assigned to receive either olaparib or a placebo (an inactive dummy treatment). The trial was primarily measuring **progression-free survival** — that is, how long participants went before their disease showed signs of worsening on scans, or before they died. Several secondary measures were also tracked, including overall survival (how long participants lived in total), and various time-based measures related to starting new treatments or stopping the study treatment. The reported data shows that for the primary measure — time until disease worsening or death — the median figure (the midpoint value across all participants in that group) was 4.3 months for the BRCA1/2-positive olaparib group, compared with 2.8 months for the BRCA1/2-positive placebo group. For those without the BRCA1/2 mutation, the reported figures were 5.3 months (olaparib) versus 2.8 months (placebo). For overall survival, the reported median figures were 20.1 months (BRCA1/2-positive, olaparib), 20.9 months (BRCA1/2-positive, placebo), 23.2 months (BRCA1/2-negative, olaparib), and 30.2 months (BRCA1/2-negative, placebo). The reported data also shows median time to starting a next treatment ranged from around 4.3 to 7.9 months across the four groups, and median time to starting a second subsequent treatment ranged from around 11.7 to 15.4 months. The reported data further shows that the time to stopping the study treatment had a median of 4.5 months (BRCA1/2-positive, olaparib), 3.4 months (BRCA1/2-positive, placebo), 5.6 months (BRCA1/2-negative, olaparib), and 3.1 months (BRCA1/2-negative, placebo). The measure tracking time to progression using a combined method (scan results plus a blood marker called CA-125) showed very similar figures of approximately 2.8–2.9 months across all four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03326193 · results posted 19 January 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03326193) enrolled 105 people, all of whom received a combination of two medicines — niraparib and bevacizumab. Of those 105 participants, 70 completed the study and 35 did not. The trial was primarily looking at how many participants had not experienced their cancer getting worse (or had not died) by the 18-month mark — a measure called the "progression-free survival rate." It also tracked several secondary measures, including how long on average participants went without their cancer progressing, how long they lived overall, and how they reported feeling during treatment using a quality-of-life questionnaire. The reported data shows that 62% of participants had not experienced disease progression or death at the 18-month mark. For the secondary measures, the reported median time before disease progression (the point at which half the participants had progressed and half had not) was 19.6 months, and the median overall survival was 61.1 months. When a blood marker for cancer called CA-125 was also used alongside the scan-based measure to detect progression, the reported median time before progression was 16.9 months. The median time before participants started a new cancer treatment after this study was 17.5 months. A quality-of-life symptom score (rated out of 32, where higher means fewer symptoms) started at an average of 25.7 at the beginning of the study, with small changes reported at various points during treatment — the reported changes ranged from around −2.0 to +0.7 points from that starting score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02289950 · results posted 2 September 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02289950) enrolled 214 people with ovarian cancer — 142 in the group receiving farletuzumab (an investigational medicine) combined with standard chemotherapy, and 72 in the group receiving a placebo combined with the same standard chemotherapy. The trial's main goal was to measure how long participants went without their cancer growing or spreading (called "progression-free survival"), and several secondary goals were also tracked, including how long participants lived overall, how their tumours responded to treatment, and how quickly and how durably those responses occurred. The reported data shows that, for the primary measure of time without cancer progression, the farletuzumab group had a reported median of 11.73 months compared with 10.78 months in the placebo group. For overall survival — that is, how long participants lived from the start of the trial — the reported median figures were 43.07 months in the farletuzumab group and 42.45 months in the placebo group. Looking at tumour responses, 24 participants in the farletuzumab group were reported to have had a complete response (tumour disappearing entirely) compared with 15 in the placebo group; 72 versus 35 had a partial response (tumour shrinking noticeably); and 36 versus 17 had stable disease (tumour neither shrinking enough to count as a response nor growing enough to count as progression). The reported data shows the time until a first response was around 2.69 months in the farletuzumab group and 2.53 months in the placebo group, and the duration of that response was reported as 10.12 months and 8.51 months respectively. Notably, the reported data shows that zero participants completed the study in either group, meaning all participants either experienced progression, died, or left the study before its formal completion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03029585 · results posted 27 April 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called NanoPac® (a form of the chemotherapy medicine paclitaxel) delivered directly into the abdominal cavity in people with ovarian cancer. It compared two doses — 100 mg/m² and 200 mg/m² — where "mg/m²" refers to the dose calculated based on a person's body surface area. A total of 10 people took part: 7 in the lower-dose group and 3 in the higher-dose group. Five people in the lower-dose group and 2 in the higher-dose group completed the study. The trial's main focus was on recording any unwanted medical events (called adverse events) that occurred after the treatment was given, and it also measured how much of the drug entered the bloodstream and how long participants went without their cancer getting worse over 12 months. The reported data shows that in the lower-dose group (100 mg/m²), a total of 80 treatment-related adverse events were recorded, while 28 were recorded in the higher-dose group (200 mg/m²). For the blood levels of the drug, the reported peak concentration of paclitaxel in the bloodstream was 12.56 ng/mL (nanograms per millilitre) in the lower-dose group and 26.50 ng/mL in the higher-dose group. Regarding how long participants went without their cancer progressing over 12 months, the reported data shows that 4 participants in the lower-dose group were progression-free at 12 months, while no participants in the higher-dose group were reported as progression-free at that point. The data was not reported in a way that allows a straightforward breakdown of the remaining progression-free survival figures across both groups. It is worth noting that only 10 people took part in total, which is a very small number, and results from small trials like this should be interpreted with great 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.
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NCT01849874 · results posted 30 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01849874) enrolled 341 people in total — 228 assigned to a medicine called MEK162 and 113 assigned to a group receiving their doctor's chosen treatment (referred to as "Physician's Choice"). The trial was primarily measuring how long participants went without their disease getting worse (called progression-free survival), and also tracked a number of secondary measures including how long participants lived overall, how many showed a measurable reduction in their cancer, how long those responses lasted, and how many experienced unwanted medical events during the trial. The reported data shows that, for the main measure — time until disease progression or death — the MEK162 group had a reported median of 9.10 months, compared with 10.58 months in the Physician's Choice group. (A "median" means half the participants in each group reached that point before that time, and half after.) For overall survival, the reported median was 25.33 months in the MEK162 group and 20.83 months in the Physician's Choice group. The reported data shows that 16% of participants in the MEK162 group and 13% in the Physician's Choice group had a measurable reduction in their cancer. Among those who did respond, the response lasted a reported median of 8.05 months (MEK162) and 6.67 months (Physician's Choice). The disease control rate figures were not reported in the submitted data. Regarding unwanted medical events, the reported data shows that all 227 treated MEK162 participants and 105 of the 106 treated Physician's Choice participants experienced at least one adverse event, with serious adverse events reported in 126 MEK162 participants and 31 Physician's Choice participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00945191 · results posted 18 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom received a combination of an investigational drug called CS-1008 together with two standard chemotherapy medicines, paclitaxel and carboplatin. The trial was looking at how patients with locally advanced or metastatic (spread) ovarian cancer responded to this treatment combination. Notably, the reported data shows that none of the 24 participants were recorded as having "completed" the study in the formal sense — all 24 were listed under "not completed," though this does not necessarily mean they dropped out early, as it may reflect how the study's completion criteria were defined. The reported data shows that when it came to the main (primary) outcome — the best overall tumour response — no participants had a confirmed complete response (disappearance of all measurable tumours) and no participants had a confirmed partial response (tumours shrinking by at least 30%). Of the 24 participants, 4 were reported as having stable disease (tumours neither shrinking enough to count as a response nor growing enough to count as progression), 5 had progressive disease (tumours growing), and 2 were not evaluable. The remaining participants fell into unconfirmed response categories. For a secondary measure, the reported data shows changes in the combined size of target tumours from the start of treatment, with figures of approximately −39.0 mm, −52.4 mm, and −48.3 mm recorded across different time points or subgroups — negative numbers indicating a reduction in tumour size measurements. Regarding side effects, the reported data shows that 22 of the 24 participants experienced at least one treatment-emergent adverse event rated as severe or worse (Grade 3 or higher), including 20 with blood-related issues, 18 with general body symptoms, and smaller numbers with other organ-system effects; the data also records 1 participant with a Grade 5 event, meaning a side effect associated with death. 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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NCT00391118 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people across three groups. Eleven participants took part in a preliminary safety phase (Part 1 – Modified Regimen A), while the main part of the trial (Part 2) included 69 people in Regimen A and 73 in Regimen B. The trial was primarily measuring how long participants went without their cancer getting worse (called "progression-free survival"), and also looked at how many people's cancer responded to treatment and how many experienced serious medical events. The reported data shows that, in Part 2, the median time before cancer worsened or participants died was 18.9 months for those in Regimen A and 15.2 months for those in Regimen B. ("Median" means half the participants reached this point sooner, and half took longer.) At the two-year mark, approximately 35% of Regimen A participants and 28% of Regimen B participants had not yet had their cancer worsen. When looking at tumour response, around 43% of Regimen A participants and 39% of Regimen B participants were recorded as having a complete or partial response — meaning scans showed their tumours had shrunk or disappeared. The reported data also shows that serious medical events were recorded in 26 people in Regimen A and 20 people in Regimen B during Part 2, with non-serious adverse events recorded in 60 and 56 people respectively. Regarding the biological marker analysis, the reported data shows varying progression-free survival figures depending on the level of certain proteins measured in tumour tissue, with results ranging from approximately 10 to 19 months across the different markers and groups — though some figures were not reported for certain subgroups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02101788 · results posted 29 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 260 people in total — 130 in the control group (Arm A, which included standard treatments such as letrozole, tamoxifen, paclitaxel, and others) and 130 in the experimental group (Arm B, which received a drug called trametinib). The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as overall survival, tumour response, side effects, and self-reported quality of life. Notably, 88 participants in the control group whose disease progressed were later permitted to cross over and receive the experimental treatment. The reported data shows that, for the primary measure — the time before disease progression or death — the control group had a reported average of 7.2 months, while the experimental group had a reported average of 13.0 months. For overall survival (time from enrolment until death from any cause), the reported figures were 29.2 months for the control group and 37.0 months for the experimental group. Regarding tumour response (tumours shrinking to a meaningful degree), the reported data shows 8 participants in the control group and 34 in the experimental group met that measure. For serious side effects (graded 3 or higher), the data shows varying numbers across different categories of adverse events in both groups, though the full breakdown of each individual category was not clearly separated in the submitted data. Quality-of-life scores (on a scale of 0–100, where higher means better) were reported as similar between the two groups at the start of the trial (both 74.5), with small fluctuations across follow-up time points in both groups. Peripheral neuropathy symptom scores (on a scale of 0–16, where higher means fewer symptoms) were also reported as broadly similar across both groups throughout 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 ↗
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NCT02470585 · results posted 14 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02470585) enrolled 1,140 people in total, split across three groups of roughly 375–383 participants each. The trial was comparing three different treatment approaches for cancer: one group received chemotherapy (carboplatin and paclitaxel) plus a dummy tablet (placebo) during and after chemotherapy; a second group received the drug veliparib alongside chemotherapy but then switched to a placebo afterwards; and a third group received veliparib alongside chemotherapy and continued taking veliparib afterwards. The main thing the trial measured was "progression-free survival" — that is, how many months participants went without their disease getting worse or dying. The reported data shows the results across three different subgroups of participants. For participants whose cancer had a specific gene fault called a BRCA deficiency, the placebo group went a reported median (middle value) of 22.0 months without their disease worsening, the veliparib-during-chemotherapy-only group 21.1 months, and the veliparib-throughout group 34.7 months. For a broader group of participants whose cancer had a related DNA-repair fault (called homologous recombination deficiency), the reported figures were 20.5 months, 18.1 months, and 31.9 months respectively. When looking at all participants regardless of gene status, the reported median progression-free survival figures were 17.3 months for the placebo group, 15.2 months for the veliparib-during-chemotherapy-only group, and 23.5 months for the veliparib-throughout group. The reported data shows these figures as medians — meaning half the participants in each group reached that point sooner and half took longer. No other outcome figures were reported in the submitted results data beyond these progression-free survival numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03414047 · results posted 17 June 2020
According to the results reported on ClinicalTrials.gov, this trial tested a drug called prexasertib in people with ovarian cancer. Participants were divided into four groups (called cohorts) based on their cancer type or characteristics. In total, 169 people started the trial — 53 in Cohort 1, 46 in Cohort 2, 41 in Cohort 3, and 29 in Cohort 4. The main thing the trial was measuring was how many participants' tumours shrank or disappeared (known as the "overall response rate"). The trial also tracked how long those responses lasted, how long participants went without their disease getting worse, changes in a blood marker called CA-125, and how the drug moved through the body. The reported data shows that, for the main measure, the percentage of participants whose tumours shrank significantly or disappeared was 11.3% in Cohort 1, 13.0% in Cohort 2, 12.2% in Cohort 3, and 6.9% in Cohort 4. For a broader measure — the percentage of participants whose disease either shrank or stayed stable for at least four months — the reported figures were 45.3% (Cohort 1), 32.6% (Cohort 2), 31.7% (Cohort 3), and 31.0% (Cohort 4). Among those whose tumours did respond, the reported length of time that response lasted ranged from approximately 3.8 months (Cohort 2) to 8.6 months (Cohort 1). The reported time from enrolment until disease worsened or death (progression-free survival) was between roughly 3.6 and 3.9 months across all four cohorts. The percentage of participants who showed at least a 50% drop in the CA-125 blood marker ranged from about 17% (Cohort 3) to approximately 40% (Cohort 1). 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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NCT03759587 · results posted 25 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03759587) enrolled 19 participants, all of whom received a 300 mg daily dose of a drug called niraparib. The trial was primarily looking at how many participants developed a serious drop in blood platelet levels — known as thrombocytopenia (platelets are tiny blood cells that help with clotting) — within the first 30 days of starting the drug. The trial also tracked a range of other unwanted medical events that occurred after participants began treatment. Notably, none of the 19 participants completed the study, and only 5 were included in a smaller group assessed for treatment response. The reported data shows that 6 out of 19 participants experienced a severe or serious drop in platelet levels (graded as Grade 3 or 4, meaning the drop was either medically significant or potentially life-threatening) within the first 30 days. For the secondary measurements, all 19 participants were reported to have experienced at least one unwanted medical event after starting the drug. Of those, 14 participants experienced events graded as severe or worse (Grade 3 or higher). The reported data also shows that 4 participants had what were classified as "serious" adverse events — those resulting in hospitalisation, being life-threatening, or other significant consequences. Additionally, 16 out of 19 participants had their dose temporarily interrupted, and 5 participants stopped taking the drug altogether due to unwanted medical events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02718417 · results posted 18 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 998 people in total across three groups: 332 people received chemotherapy followed by a drug called avelumab, 331 received chemotherapy combined with avelumab from the start and then continued on avelumab, and 335 received chemotherapy followed by observation only (no further treatment). The trial was primarily measuring how long participants went without their cancer getting worse or spreading — a period called "progression-free survival" — as judged by an independent review panel who did not know which treatment each person had received. The reported data shows that, for the main outcome measured by that independent panel, the group who received chemotherapy followed by avelumab went a median (middle value across the group) of 16.8 months before their cancer progressed or they died, and the group who received chemotherapy combined with avelumab from the start went a median of 18.1 months. A comparable figure for the observation group was not reported for this particular measure. When the treating doctors (rather than the independent panel) assessed the same outcome, the reported figures were 13.8 months, 16.1 months, and 15.0 months for the three groups respectively. For overall survival — how long participants lived — the data was not reported as a final number for any of the three groups at the time of this submission. Regarding tumour shrinkage, the reported data shows that between roughly 26% and 36% of participants in each group had their tumours shrink to a measurable degree, depending on the group and who did the assessment. Among those whose tumours did shrink, the reported data shows the shrinkage lasted a median of 10.6 months in the chemotherapy-then-avelumab group, was not yet reported as a final number in the combined avelumab group, and lasted a median of 15.4 months in the observation group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02580058 · results posted 19 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02580058) enrolled 566 people across three groups: 188 received avelumab alone, 188 received avelumab combined with pegylated liposomal doxorubicin (PLD, a type of chemotherapy), and 190 received PLD alone. The trial was measuring two main things: how long participants lived overall (called overall survival), and how long they went without their disease getting worse (called progression-free survival). Notably, the reported data shows that no participants were recorded as having "completed" the study, meaning all participants either left or the study ended before a formal completion milestone was reached. The reported data shows the following numbers for overall survival — that is, the midpoint estimate (the point at which half the group had died and half had not): 11.8 months for the avelumab-alone group, 15.7 months for the avelumab-plus-PLD group, and 13.1 months for the PLD-alone group. For progression-free survival — how long until disease worsening or death was first recorded — the reported midpoint figures were 1.9 months for avelumab alone, 3.7 months for the combination group, and 3.5 months for PLD alone. Among the secondary outcomes, the reported data shows that the percentage of participants whose tumours shrank by a meaningful amount (called the objective response rate, as assessed by an independent review team) was 3.7% for avelumab alone, 13.3% for the combination, and 4.2% for PLD alone. For those who did respond, the reported duration of that response was 9.2 months, 8.5 months, and 13.1 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.
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NCT02145247 · results posted 12 August 2019
According to the results reported on ClinicalTrials.gov, this trial involved 39 women in total — 20 women without any known hormonal condition (described as "normal adult women") and 19 women who had been diagnosed with polycystic ovary syndrome (PCOS). All 39 participants completed the study, with no dropouts reported. The trial was measuring how levels of a hormone called 17-OHP (17-hydroxyprogesterone, a hormone produced by the ovaries and adrenal glands) changed after participants were given a single intravenous dose of a medication called recombinant hCG — a synthetic version of a hormone that normally triggers hormone release. Blood samples were taken before and after the injection to track any change. The reported data shows that, on average, 17-OHP levels rose by 67% from the starting level in the group of normal adult women, and by 140% from the starting level in the group of women with PCOS, following the injection. These figures represent the percentage change — that is, how much higher the hormone level was after the injection compared to before it. No secondary outcome measures were included in the structured results data submitted to ClinicalTrials.gov, so no other figures are available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01844986 · results posted 9 July 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 455 people in total. In the main (global) group, 260 people received olaparib 300mg tablets and 131 received a placebo (a dummy tablet with no active ingredient). A separate group of 64 participants was enrolled in China (44 on olaparib, 20 on placebo). All participants had advanced ovarian cancer with a BRCA gene mutation and had responded to platinum-based chemotherapy. The trial was primarily measuring how long participants went without their cancer getting worse — known as "progression-free survival" — and also tracked a number of other outcomes including overall survival, time until a second treatment was needed, and quality of life. The reported data shows that for the primary outcome of time without cancer progression, a median figure (the point at which half the participants had experienced progression) was only reported for the placebo groups: 13.8 months in the global cohort and 9.3 months in the China cohort. The median figures for the olaparib groups were listed as "NA" (not available/not reached), meaning that at the time of reporting, at least half of those participants had not yet experienced progression. For the secondary outcome measuring time to first subsequent therapy or death, the reported data shows a median of 51.8 months for the olaparib group and 15.1 months for the placebo group in the global cohort, and 34.3 months versus 10.3 months in the China cohort. Overall survival data was not reported for any group, with final results anticipated in 2029. For quality-of-life scores (measured on a scale of 0–100, where higher means better), the reported data shows an average change from the starting score of +0.30 for the olaparib group and +3.30 for the placebo group in the global cohort. 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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NCT01621542 · results posted 5 April 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people in total across six groups, each receiving a different dose of a study drug called WT2725 (0.3 mg, 0.9 mg, 3.0 mg, 9 mg, 18 mg, or 27 mg). The trial was designed to look at two main things: whether the drug caused serious side effects at each dose level (called "dose-limiting toxicities," meaning side effects serious enough to stop or limit further dosing), and to find the highest dose that could be given without those serious side effects occurring. It also looked at whether there were any signs of the drug acting against participants' tumours. The reported data shows that none of the 62 participants were recorded as having completed the study — all were listed under "not completed," though the data does not explain the reasons for this in detail. The reported data shows that across all six dose groups, the number of dose-limiting toxicities recorded was zero, meaning no such serious side effects were reported at any dose level during the monitoring period. Because no dose-limiting toxicities were observed, the data as submitted does not identify a single maximum tolerated dose. For the secondary outcomes — which looked at signs of tumour response — the reported data shows that in the 9 mg group, 2 out of 28 participants with solid tumours showed a measurable tumour response, and 3 out of 28 showed an immune response (assessed using a separate set of criteria for a blood cancer called AML). In the 18 mg group, no solid tumour responses were recorded, while 2 participants showed an immune response. In the 27 mg group, 1 participant showed a solid tumour response and none showed an immune response. No tumour or immune responses were reported in the three lower-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02073929 · results posted 28 February 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 72 people in total — 48 in the liraglutide group and 24 in the placebo group. Of these, 44 and 21 people respectively completed the study. The trial was measuring how liraglutide (an injectable diabetes and weight-management medicine) compared to a placebo (an inactive dummy treatment) across several markers related to blood clotting and inflammation. The main thing being measured was something called Endogenous Thrombin Potential (ETP) — a laboratory test that indicates how strongly the blood is primed to form clots, expressed as a score calculated over time. The reported data shows that, on average, the ETP score changed by −56.7 units (nMolar × minutes) in the liraglutide group compared to −8.2 units in the placebo group — meaning both groups showed a reduction in this clotting measure from their starting point, with a larger reduction seen in the liraglutide group. For the secondary outcome, a substance called PAI-1 — which is involved in the body's ability to break down clots — changed by −12% in the liraglutide group and by +4% in the placebo group. Several other blood markers were also measured: a marker of inflammation called CRP changed by −15% in the liraglutide group and −25% in the placebo group; a heart-related marker called ANP changed by −11.5 units in the liraglutide group and +1.4 units in the placebo group; a marker called adrenomedullin changed by −0.02 units versus +0.003 units; and a marker called copeptin changed by +0.48 units versus +0.28 units. The reported data does not include information about the spread or reliability of these figures, so they should be understood as group averages only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01846611 · results posted 6 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01846611) involved 576 people in total — 289 who were assigned to receive a combination of trabectedin and DOXIL (a chemotherapy medicine), and 287 who received DOXIL alone. The trial was measuring how long participants lived overall, how long they lived before their cancer got worse, and how many participants saw their tumours shrink or disappear. The reported data shows that, for overall survival (how long participants lived from the start of the trial), the trabectedin-plus-DOXIL group had a reported median of 23.82 months, compared with 22.21 months for the DOXIL-alone group. (Median means half the participants in each group lived longer than that figure, and half did not reach it.) For progression-free survival (the time before the cancer got worse or a participant died), the reported median was 7.52 months in the combination group and 7.26 months in the DOXIL-alone group. For the objective response rate — meaning the percentage of participants whose tumours shrank significantly or disappeared entirely — the reported figures were 46.0% in the combination group and 35.9% in the DOXIL-alone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01968213 · results posted 3 August 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01968213) enrolled 564 people in total — 375 received rucaparib 600 mg tablets and 189 received placebo tablets. The trial was measuring how long people with ovarian cancer went without their disease getting worse or dying (called "progression-free survival"), as well as how long they lived overall, and how their cancer-related symptoms changed over time. The reported data shows that for the main measure — the time until the cancer was assessed by the treating doctor as getting worse, or until death — the rucaparib group had a reported median of 10.8 months, compared with 5.4 months in the placebo group. (A "median" is the midpoint value — half the people had a longer time, half had a shorter time.) When an independent panel of radiology reviewers assessed disease progression instead of the treating doctor, the reported median figures were 13.7 months for rucaparib and 5.4 months for placebo. For overall survival — the time from entering the trial until death from any cause — the reported median was 36.0 months for the rucaparib group and 43.2 months for the placebo group. Regarding symptom questionnaire scores, the reported data shows that the time until participants recorded a notable worsening in physical symptoms was 1.9 months in the rucaparib group versus 6.4 months in the placebo group, and the time to a notable worsening in the overall symptom score was 2.9 months versus 10.8 months respectively. Blood concentration measurements of rucaparib were also reported, with values around 1,128–1,165 ng/mL, though the full details of what these individual figures represent were not clearly described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01708161 · results posted 28 June 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01708161) enrolled 47 participants in total across two phases. The first phase (Phase Ib) tested three different dose combinations of two drugs — alpelisib (BYL) and ganitumab (AMG) — in 24 people, to look at how the body handled the treatment and to identify any dose-limiting side effects (meaning side effects serious enough to stop a dose from being increased further). The second phase (Phase II) enrolled 23 more participants with either hormone receptor-positive breast cancer or ovarian cancer whose tumours had a specific gene change (PIK3CA mutation or amplification). Notably, the reported data shows that none of the participants in any group completed the study. The reported data shows that in Phase Ib, only one participant experienced a dose-limiting side effect, and that was in the highest dose group (350mg alpelisib plus 12mg/kg ganitumab). When looking at how tumours responded to treatment in Phase II — measured using a standard imaging-based method called RECIST — 12.5% of hormone receptor-positive breast cancer participants and 16.7% of ovarian cancer participants showed a complete or partial reduction in tumour size, giving an overall figure of 13% across both groups. A broader measure called "disease control rate" (which also counts tumours that stayed stable and did not grow) was reported at 43.8% for the breast cancer group, 50% for the ovarian cancer group, and 47.8% overall in Phase II. Blood level measurements of alpelisib were also recorded but were not reported in a way that allows plain comparison across doses. The reported data also shows that in the earlier Phase Ib portion, no participants achieved a complete or partial tumour response as measured by RECIST, though some showed stable disease. Disease control rates in that phase ranged from about 9% to 50% depending on the dose group, though the small numbers in each group mean these figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01091428 · results posted 4 June 2018
According to the results reported on ClinicalTrials.gov, this trial involved two phases and a total of 191 participants across four groups. In Phase 1, 38 people with ovarian cancer and 11 people with breast cancer took part to help work out the right doses of two drugs — alisertib and paclitaxel — when given together, and to record any notable medical events that occurred. In Phase 2, 73 people received the combination of alisertib (40 mg twice daily) plus paclitaxel (60 mg/m²), and 69 people received paclitaxel alone (80 mg/m²). Notably, the reported data shows that zero participants in any group were recorded as having formally "completed" the trial under the trial's own completion criteria, though the reasons for this are not detailed in the submitted data. The reported data shows that the Phase 1 dose-finding process arrived at 40 mg of alisertib and 60 mg/m² of paclitaxel as the recommended doses to carry forward into Phase 2. Regarding medical events recorded during Phase 1, all 38 ovarian cancer participants and all 11 breast cancer participants experienced at least one adverse event (an unexpected medical occurrence during the study). Of those, 13 ovarian cancer participants and 2 breast cancer participants experienced a serious adverse event — meaning an event considered significant enough to involve hospitalisation, be life-threatening, or cause lasting harm. The reported data also shows that 3 ovarian cancer participants and no breast cancer participants had clinically notable changes in certain blood or urine test results, and that 8 ovarian cancer participants and 5 breast cancer participants had clinically notable changes in vital signs such as blood pressure or pulse. One ovarian cancer participant was recorded as experiencing a hypersensitivity reaction; no neurotoxicity events were reported in either group. No outcome measure numbers were reported for the Phase 2 portion of the trial in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01428193 · results posted 4 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom received a combination of three medications: flutamide, Estrace (a form of oestrogen), and progesterone. The trial was measuring how levels of a hormone called luteinising hormone (LH) — which plays a role in the reproductive system — changed in response to progesterone levels recorded on day 7 of the study. Of the 4 people who started, 2 completed the trial and 2 did not. The reported data shows that the primary outcome measured was the "slope" of the percentage change in LH pulses — in plain terms, this is a way of describing the rate and direction of change in LH levels as progesterone levels varied. The reported figure for this slope was -0.55 percentage points of change. A negative number here indicates that as progesterone levels on day 7 increased, LH pulses tended to decrease. No secondary outcome measures or additional data were reported in the submitted results. It is worth noting that with only 4 participants enrolled and only 2 completing the trial, the amount of data available from this study is very limited. The reported data shows a single numerical result, and no further breakdown or additional measurements were included in what was submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01653912 · results posted 2 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01653912) tested a drug called GSK2110183 in people with recurrent ovarian cancer. The trial had two stages. In the first stage (Phase 1), 29 participants were given increasing doses of the drug — 50 mg, 75 mg, 100 mg, 125 mg, or 150 mg — to find the highest dose that could be given without too many serious side effects. In the second stage (Phase 2), 30 participants received the dose identified in Phase 1, which was 125 mg. The reported data shows that in Phase 1, the highest dose considered manageable (called the "maximum tolerated dose") was 125 mg. Across all Phase 1 participants, 26 out of 29 people experienced at least one side effect rated as severe or worse (grade 3 or above) according to a standard medical grading scale. In the Phase 2 group of participants with platinum-resistant ovarian cancer (meaning a cancer that had stopped responding to a particular type of chemotherapy), the reported overall response rate — the percentage of people whose tumours either disappeared completely or shrank by at least 30% — was approximately 32%. This was made up of around 7% with a complete disappearance of tumours and around 25% with a significant shrinkage. For the Phase 2 group with platinum-refractory cancer (cancer that never responded to that chemotherapy), no response rate data was reported. In Phase 1 participants with platinum-resistant cancer, the reported overall response rate was approximately 24%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01874353 · results posted 7 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01874353) enrolled 327 people in total across two groups of participants — a global cohort and a China cohort. All participants had ovarian cancer with a BRCA gene mutation and had responded (either fully or partially) to platinum-based chemotherapy. They were randomly assigned to take either olaparib tablets (300mg) or a placebo (dummy tablet) as a maintenance treatment — meaning treatment given after chemotherapy to try to delay the cancer returning. The trial's main goal was to measure how long participants went without their cancer getting worse, known as "progression-free survival." The reported data shows that, for the primary measure of how long until the cancer progressed, the global cohort taking olaparib had a reported median (the midpoint value for the group) of 19.1 months, compared to 5.5 months for the global cohort taking the placebo. In the China cohort, the reported figures were 13.8 months for olaparib and 5.5 months for placebo. For overall survival (how long participants lived in total), the reported median figures were 51.7 months (olaparib, global) versus 38.8 months (placebo, global), and 41.7 months (olaparib, China) versus 36.4 months (placebo, China). For the time until participants started a next treatment or died, the reported medians were 27.4 months (olaparib, global) versus 7.2 months (placebo, global). The reported data shows that for the time from the start of the trial to a second progression, a result was not reported for the olaparib groups (listed as "NA" in the data), while the placebo groups reported 18.4 months (global) and 17.3 months (China). A quality-of-life measure showed a very small reported change from the starting score over 12 months in both the olaparib group (−2.90 points out of 100) and the placebo group (−2.87 points out of 100) in the global cohort; quality-of-life data for the China cohort 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.
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NCT00699907 · results posted 5 January 2018
According to the results reported on ClinicalTrials.gov, a total of 127 people took part in this trial across three groups: a Treatment Arm (14 participants), a High Risk Arm (57 participants), and a Low Risk Arm (56 participants). The trial was measuring the levels of two proteins — Colony Stimulating Factor-1 (CSF-1) and its paired receptor (CSF-1R) — in ovarian tissue samples taken from participants. These proteins were detected using a laboratory staining technique, and their levels were scored on a numerical scale (called an H-Score), where a score closer to 0 means very little of the protein was detected, and a score closer to 300 means a high amount was detected. The reported data shows that across all tissue areas measured — including a type of ovarian lining tissue called endosalpingiosis, the surface layer of the ovary (epithelium), and the deeper supporting tissue (stroma) — the High Risk Arm consistently recorded the highest scores for both proteins. For example, in endosalpingiosis tissue, the High Risk Arm recorded a CSF-1 score of 130 and a CSF-1R score of 160, compared to scores of 50 and 75 respectively in the Low Risk Arm, and scores of just 5 and 15 in the Treatment Arm. The reported data shows a similar pattern in the epithelium and stroma, where the High Risk Arm again returned higher scores than the other two groups, and the Treatment Arm generally returned the lowest scores across all measurements. 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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NCT00053352 · results posted 8 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 302 participants across two groups: 190 people in Arm 1 and 112 people in Arm 2. Of those, 169 in Arm 1 and 102 in Arm 2 completed the study. The trial was measuring how many participants survived and remained free of disease-related events over three years, as well as looking at hospital stay length and certain side effects for those in Arm 1 who received chemotherapy. The reported data shows that for Arm 1, the probability of being alive at three years was reported as 97%, and the probability of being free from disease-related events (such as relapse or the need to change treatment) at three years was reported as 87%. For Arm 2, the probability of being alive at three years was reported as 99%. Event-free survival was not measured as a primary outcome for Arm 2 participants. For those in Arm 1 who received chemotherapy, the average number of days spent in hospital was reported as approximately 14 days. The reported data also shows that a number of Arm 1 participants experienced serious side effects (graded as severe or higher on a standard medical scale) during treatment — the most commonly reported category involved 58 patients, with smaller numbers reported across other side effect categories. The full breakdown of each specific side effect type was not included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01617629 · results posted 8 December 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01617629) involved a single group of 9 participants who received a treatment called Cvac. The trial was measuring how many participants experienced adverse events (unexpected or unwanted medical occurrences during the study) and serious adverse events (more severe occurrences such as hospitalisation, life-threatening events, or death). Three participants completed the study, while six did not complete it. Overall survival — meaning the length of time participants lived from the start of the trial — was also listed as an outcome the researchers intended to look at. The reported data shows that out of the 9 participants, 7 experienced adverse events during the study period. Additionally, 2 participants experienced serious adverse events, as defined above. These are the only numbers provided in the submitted results. No figures were reported for overall survival, so that data was not available in the submitted results 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.
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NCT01118052 · results posted 30 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people who all received the study treatment, a drug called EGEN-001. Twenty of the 22 participants completed the study, while 2 did not finish. The trial was looking at three main things: how many people went at least 6 months without their disease getting worse, whether any tumours shrank or disappeared, and what unwanted side effects occurred that may have been linked to the treatment. The reported data shows that 6 out of 22 participants went at least 6 months without their disease progressing (getting worse), while 14 out of 22 did not reach that point. When it came to tumour shrinkage, the reported figure was 0% — meaning none of the participants were recorded as having a complete or partial tumour response (where a tumour either disappears entirely or shrinks by a meaningful amount). Regarding unwanted effects possibly linked to the treatment, the reported data shows that the majority of participants — 18 out of 22 — experienced no such side effects (Grade 0, meaning none). Small numbers experienced mild effects rated Grade 1 or Grade 2 on a standard medical scale, and no participants were recorded as experiencing more serious effects at Grade 3, 4, or 5. The reported data also includes two secondary (additional) measures. The median overall survival — meaning the midpoint length of time participants lived from the start of the study — was reported as 9.2 months. The median progression-free survival — the midpoint length of time before the disease got worse or participants passed away — was reported as 2.9 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00407758 · results posted 21 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people, all of whom received a drug called enzastaurin. Twenty-seven participants completed the study, while one did not. The trial was measuring how many participants' tumours shrank or disappeared (called "tumour response"), how many went at least six months without their disease getting worse, and how often serious unwanted effects (graded as severe or worse) occurred during treatment. The reported data shows that out of 28 participants, 2 had a partial response — meaning their tumours shrank by at least 30% — and none had a complete response (full disappearance of all tumours). When it came to disease stability over time, 3 participants went more than six months without their disease progressing, while 24 did not reach that milestone. Regarding serious unwanted effects (those rated "Grade 3 or higher," meaning severe), the reported data shows varying numbers of participants experienced different types across several categories — for example, individual counts of 1, 5, 11, 2, 4, 1, 5, 5, 1, and 3 participants were recorded for each category, though the specific names of those categories were not provided in the submitted data. The reported median overall survival (the midpoint of how long participants lived from study entry) was 15.1 months, and the median time before the disease progressed or worsened was 1.8 months. Additionally, 11 participants were classed as "platinum sensitive" (meaning their cancer had previously responded to a certain type of chemotherapy) and 16 were not. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00466960 · results posted 28 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom completed the study — none dropped out. All participants received the same treatment, which combined a colony stimulating factor (a type of medication that stimulates the immune system's blood cell production) with chemotherapy. The trial was primarily measuring how long it took for the disease to progress (get worse) and how many participants showed a measurable reduction in their cancer. The reported data shows that the median time to progression — meaning the point at which half the participants had experienced their disease getting worse — was approximately 4 months (4.07 months). Out of the 21 participants, 15 were reported to have achieved either a complete or partial response, meaning their cancer showed a measurable reduction during the trial period. The trial also looked at several secondary measures involving blood cell counts and immune system markers. The reported data shows that participants who had a complete response appeared to have a higher baseline level of certain immune cells called monocytes (around 20.75%) compared to those who had a partial response, no response, or stable disease (around 12.75%). Various other immune cell measurements and correlation figures were also reported for different immune cell types, though the detail behind some of these figures is complex and was not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00582205 · results posted 18 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people who received a combination of paclitaxel and cisplatin delivered directly into the abdomen (a method called intraperitoneal chemotherapy). The trial was looking at how many participants were able to complete the full planned course of treatment — six cycles of this chemotherapy — and also tracked how many experienced side effects serious enough to require a reduction or delay in their doses. The reported data shows that out of the 21 people who started the trial, 11 completed it and 10 did not. Of the primary outcome — the number of participants who were able to receive all six planned cycles of the intraperitoneal cisplatin chemotherapy — 7 out of 21 participants were reported to have done so. For the secondary outcome, the reported data shows that 7 participants experienced dose reductions or delays due to nerve-related side effects (neuropathy) or other toxic effects from the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01936363 · results posted 7 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people with ovarian cancer across two groups. Thirty-two participants received pimasertib (taken once daily) combined with another drug called SAR245409, while 33 participants received pimasertib (taken twice daily) alongside a placebo (a dummy pill with no active ingredient) instead of SAR245409. The trial was primarily measuring whether tumours shrank or disappeared — known as an "objective tumour response" — and also tracked how long participants went without their cancer getting worse, overall survival, disease control, and quality of life. The reported data shows that in the once-daily pimasertib plus SAR245409 group, 12.5% of participants had their tumour shrink or disappear, compared with 12.1% in the twice-daily pimasertib plus placebo group. For how long participants went without their disease progressing (getting worse), the reported median time — meaning the midpoint figure where half did better and half did worse — was approximately 10 months in the once-daily combination group and about 12.7 months in the twice-daily group. Regarding disease control (tumour shrinkage or the cancer staying stable for at least 16 weeks), 50% of participants in the once-daily group and 39.4% in the twice-daily group met that measure. For overall survival, the data reported the number of deaths: 8 in the once-daily group and 6 in the twice-daily group, with 24 and 27 participants respectively still alive at the time of reporting. The quality-of-life questionnaire results were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00068601 · results posted 4 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 131 women in the standard chemotherapy group and 126 women in the chemotherapy-plus-goserelin group (257 participants in total). The trial was looking at whether adding a hormone-suppressing drug called goserelin to standard chemotherapy affected the likelihood of women experiencing ovarian failure — meaning their ovaries stopping normal function — after treatment for breast cancer. The main thing the researchers measured was the rate of a specific type of ovarian failure at two years, defined as having no menstrual periods for six months alongside hormone levels in the post-menopausal range. The reported data shows that for the primary outcome — premature ovarian failure at two years — 15 women in the standard chemotherapy group and 5 women in the chemotherapy-plus-goserelin group met that definition. For the secondary outcomes, the trial also tracked a broader measure called "ovarian dysfunction" (no periods for three months plus certain hormone levels out of the normal range): at one year, 28 women in the standard chemotherapy group and 18 in the goserelin group met this definition; at two years, those numbers were 22 and 9 respectively. Data for the "ovarian reserve" outcome (measuring specific hormone levels at one and two years) 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 ↗
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NCT00738699 · results posted 30 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 415 people in total — 275 in the group receiving an experimental antibody called farletuzumab combined with the chemotherapy drug paclitaxel, and 140 in the group receiving a placebo (salt water) combined with paclitaxel. The trial was measuring two main things: how long participants went without their cancer growing or spreading (called "progression-free survival"), and how long participants lived overall ("overall survival"). Two additional outcomes — a planned measure of progression based on a different set of criteria, and a measure of a cancer marker in the blood — were not analysed because the study was stopped early. The reported data shows that for progression-free survival (the time before cancer worsened or death occurred), the farletuzumab group had a median of 3.5 months, compared with 3.7 months in the placebo group. For overall survival, the farletuzumab group had a median of 11.3 months, compared with 13.1 months in the placebo group. (A "median" here means the midpoint figure — half the participants in each group had a result above that number, and half below.) For the secondary outcome of best overall response — the percentage of participants whose tumours showed a meaningful reduction — the reported data shows 0.4% had a complete response and 7.3% had a partial response in the farletuzumab group, compared with 0% complete response and 15.0% partial response in the placebo group. The median time from the start of the trial until a tumour response was first recorded was 2.0 months in the farletuzumab group and 1.7 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01248949 · results posted 29 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01248949) tested an investigational drug called MEDI3617, both on its own and in combination with other cancer medicines (bevacizumab, paclitaxel, or carboplatin/paclitaxel). A total of 116 people took part across five treatment groups. The trial was primarily designed to look at safety — specifically, how many participants experienced serious side effects early in treatment (called "dose-limiting toxicities"), what the highest dose was that participants could tolerate, and how many participants experienced any medical events or abnormal test results after starting treatment. The reported data shows that across all five groups, very few participants experienced a dose-limiting toxicity in the early treatment period: one person each in the single-agent, bevacizumab every-three-weeks, paclitaxel, and carboplatin/paclitaxel groups, and two people in the bevacizumab every-two-weeks group. For the "maximum tolerated dose" outcome — the highest dose considered manageable — no figure was reported for any group; the data was recorded as not available. When it came to broader medical events that occurred after starting treatment, all participants across every group experienced at least one such event. Serious medical events (such as those requiring hospitalisation) were reported in 18 of 42 people in the single-agent group, 4 of 16 in the bevacizumab every-three-weeks group, 18 of 38 in the bevacizumab every-two-weeks group, 7 of 13 in the paclitaxel group, and 4 of 7 in the carboplatin/paclitaxel group. Abnormal blood or laboratory test results recorded as medical events, abnormal vital signs (such as blood pressure or heart rate), and abnormal heart scan results were each reported in small numbers of participants across the groups, with full breakdowns available in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00002931 · results posted 4 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 participants, all of whom received high-dose chemotherapy combined with an autologous stem cell transplant (where a person's own stem cells are collected, stored, and returned to the body after intensive chemotherapy). Forty-six of the 48 participants completed the study, with 2 not completing it. The trial was primarily measuring two things: how long participants went without their cancer getting worse (called "progression-free survival"), and what serious side effects occurred. It also tracked how long participants lived overall. The reported data shows that the estimated median time without the cancer progressing was 11.8 months — meaning that, at that point in time, around half the participants had experienced their disease worsening and half had not. The estimated median overall survival — the point at which around half the participants were still alive — was reported as 21.7 months. Regarding serious side effects, the trial recorded the number of participants who experienced grade 3 or 4 adverse events (meaning moderate-to-severe reactions considered related to the treatment). The reported data lists counts across a number of different side effect categories, including figures such as 4, 6, 10, 5, 1, 3, 3, 2, 2, 1, 2, and 1 participants per category, though the specific labels for each category were not included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01521143 · results posted 14 December 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01521143) investigated a treatment called Cvac for epithelial ovarian cancer. The trial was run in two parts. In Part A, 40 people were assigned to Cvac and 36 to a placebo (an inactive treatment used for comparison); of these, 20 in each group went on to actually receive their assigned treatment, and 11 (Cvac) and 10 (placebo) completed the study. In Part B, 8 people were assigned to Cvac and 7 to observational standard of care; only 3 and 4 respectively received treatment, and none completed the study. The trial was measuring how long participants lived overall, how long before they needed their next cancer treatment, and how long before their disease got worse or they died — a measure commonly called "progression-free survival." The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the primary outcome (overall survival in Part A) nor for any of the secondary outcomes across either part of the trial. This means that figures for survival time, time to next treatment, and progression-free survival were not reported in the structured results data, and it would not be appropriate to draw any conclusions about what the trial found. 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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NCT01068509 · results posted 4 August 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01068509) involved 63 participants in total across three groups: 7 people in a non-randomised Cvac group, 29 people in a randomised Cvac group, and 27 people in an observational standard-of-care group. The trial was looking at an experimental treatment called Cvac in people with ovarian cancer, and it was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"). It also tracked how long participants lived overall, along with changes in certain biological markers measured from blood samples. The reported data shows that for the primary outcome — time without disease worsening — the randomised Cvac group had a reported figure of approximately 12.89 months, while the standard-of-care group had a reported figure of approximately 8.64 months. For overall survival (how long participants lived from the start of the trial), the data was not reported for either group. The reported data also shows changes in a blood protein called Mucin 1 antibody at three different time points; at week 20, the Cvac group showed a change of +957.2 units compared with −2,854.8 units in the standard-of-care group, with both groups showing further decreases at weeks 56 and 104. Changes in several immune system markers from blood samples were also measured at the same time points, with various small numerical changes recorded for both groups across all time points. It is worth noting that relatively few participants completed the trial — only 7 out of 29 in the randomised Cvac group and 6 out of 27 in the standard-of-care group finished — which the trial's own reporting reflects. These numbers describe what was measured and recorded; they do not on their own tell us whether one approach is better 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 ↗ · Linked publication on PubMed ↗
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NCT00868140 · results posted 10 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 26 in the pioglitazone (a diabetes-related medication) group and 25 in the placebo (dummy treatment) group. All 51 participants completed the study. The trial was measuring two main things in the blood during a two-hour sugar-drink test (called an oral glucose tolerance test, or OGTT): levels of a substance called DCI-IPG (a molecule involved in how the body responds to insulin), and fasting insulin levels (the amount of insulin in the blood after an overnight fast). A secondary measure called the Matsuda Index was also tracked — this is a calculated score, ranging roughly from 0 to 12, that reflects how well the body responds to insulin, with higher scores suggesting better sensitivity and scores of 2.5 or below suggesting insulin resistance. The reported data shows that before treatment started, DCI-IPG levels during the sugar-drink test were broadly similar between the two groups (approximately 13,162 units in the pioglitazone group and 14,054 units in the placebo group), as were fasting insulin levels (around 15.0 and 15.9 units respectively). After six months, the reported DCI-IPG figures were negative in both groups, meaning levels fell relative to the starting point during the test — the pioglitazone group recorded approximately −412 units and the placebo group approximately −699 units. For fasting insulin after six months, the reported change was −8.69 units in the pioglitazone group compared with −0.24 units in the placebo group, indicating a larger recorded drop in the pioglitazone group. For the Matsuda Index, the reported score after treatment was approximately 4.29 in the pioglitazone group and 0.29 in the placebo group, compared with starting scores of around 3.36 and 3.05 respectively. It is important to note that the data as submitted does not include information about whether these differences between groups were statistically meaningful (that is, whether they were likely due to the treatment rather than chance), and no such figures were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00628251 · results posted 3 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 97 people in total, split across three groups: 32 people received olaparib at a lower dose (200 mg twice daily), 32 received olaparib at a higher dose (400 mg twice daily), and 33 received a comparator treatment called liposomal doxorubicin. The trial was primarily measuring "progression-free survival" — that is, how many participants went for a period of time without their disease visibly worsening or without dying. It also tracked a number of secondary measures, including how many people's tumours shrank, how long those responses lasted, and changes in a blood marker called CA-125 (a protein sometimes associated with certain cancers). The reported data shows that for the primary measure, 19 out of 32 participants in the lower-dose olaparib group, 20 out of 32 in the higher-dose olaparib group, and 20 out of 33 in the liposomal doxorubicin group had an event recorded (meaning their disease progressed or they died during the study period). For the secondary measures, the number of participants whose tumours shrank to a meaningful degree (a confirmed response) was reported as 8 in the lower-dose group, 10 in the higher-dose group, and 6 in the liposomal doxorubicin group. Disease control — which included people whose disease shrank or stayed stable for more than four months — was recorded in 21, 21, and 19 participants respectively across the three groups. The average length of time that a response lasted was reported as approximately 5.95 months, 6.80 months, and 5.49 months across the three groups. The reported data also shows changes in tumour size and CA-125 blood levels from the start of the trial. The best recorded reduction in tumour size was around 15.9% for the lower-dose olaparib group, 24.6% for the higher-dose group, and 14.3% for the liposomal doxorubicin group. For CA-125 levels, the best recorded reductions were approximately 37.4%, 71.2%, and 55.8% respectively. These are percentage changes from each participant's starting level, not absolute measurements, and the trial notes that some of these figures may be underestimates because some participants had not yet progressed by the time the final analysis was done. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01872078 · results posted 12 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01872078) tested a drug called AZD4901 across three different doses — 20 mg once daily, 20 mg twice daily, and 40 mg twice daily — compared to a placebo (a dummy treatment with no active ingredient). A total of 65 people took part across the four groups (16 on placebo, 15 on 20 mg once daily, 17 on 20 mg twice daily, and 17 on 40 mg twice daily). Most participants completed the trial; three people in the 20 mg twice-daily group and two in the 40 mg twice-daily group did not finish. The main thing the trial was measuring was the level of a hormone called luteinising hormone (LH) in the blood over an eight-hour period on Day 7, compared to where each participant started. The reported data shows the results as a ratio — a number showing how much the hormone level on Day 7 compared to the starting level, where 1.0 would mean no change. For the placebo group, the reported ratio was 1.118 (slightly above the starting level). For the 20 mg once-daily group, it was 0.9729 (close to the starting level). For the 20 mg twice-daily group, it was 0.8804 (somewhat below the starting level). For the 40 mg twice-daily group, it was 0.5364 (notably below the starting level). No secondary outcome measure data was included in the submitted results. Any additional measurements were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02389088 · results posted 28 September 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT02389088) enrolled 9 participants, all of whom completed both phases of the study — no one dropped out. The trial was measuring how several hormones in the blood changed across two phases: Phase I, where participants received a hormone called FSH (a fertility-related hormone) without a drug called Letrozole, and Phase II, where they received FSH together with Letrozole. The hormones tracked included oestradiol (a form of oestrogen), Inhibin B, LH, FSH, testosterone, androstenedione, and 17-OH progesterone — all chemicals the body uses to regulate reproduction. Blood samples were taken at several points over six weeks in each phase. The reported data shows the following hormone levels at the various time points measured. For oestradiol (measured in pmol/L — a unit describing how much of the hormone was present per litre of blood): in Phase I, readings ranged from 116 to 451.7 across the different time points; in Phase II (with Letrozole), readings ranged from 57.9 to 401.4. For Inhibin B (measured in ng/L): Phase I readings ranged from 85.2 to 445.5, while Phase II readings ranged from 165.2 to 427.3. For LH and FSH combined, and for testosterone, androstenedione and 17-OH progesterone, only some time-point values were reported — several readings were listed as not available in the submitted data. Where values were reported for LH/FSH, they ranged from 0.6 to 3.6 IU/L across both phases; for testosterone and related hormones, reported values ranged from 0.01 to 2.8 nmol/L. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01196741 · results posted 5 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people in total — 71 received saracatinib combined with weekly paclitaxel (a chemotherapy drug), and 36 received a placebo (an inactive dummy treatment) combined with weekly paclitaxel. The trial was looking at ovarian cancer that had come back or stopped responding to treatment, and the main thing being measured was how many participants went six months without their cancer getting worse — a measure called "progression-free survival." A number of secondary measurements were also taken, including how long participants lived overall, how many showed a measurable reduction in their cancer, and how participants rated their own quality of life. The reported data shows that after six months, 29% of participants in the saracatinib group had not seen their cancer progress, compared with 34% in the placebo group. For overall survival, the reported median (meaning the middle value in the group — half lived longer, half shorter) was 10.1 months in the saracatinib group and 12.3 months in the placebo group. The reported data shows that 29% of participants in the saracatinib group showed a measurable reduction in cancer, compared with 43% in the placebo group. For quality of life — measured using a scoring tool where a higher number means better quality of life — the saracatinib group averaged a score of 66.89, while the placebo group averaged 73.10. The median duration of response and median time to progression were not reported in the submitted data. It is worth noting that only 11 of the 71 participants in the saracatinib group, and 8 of the 36 in the placebo group, were recorded as having completed the study; the rest did not complete it, though the reasons were not detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00467051 · results posted 20 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, all of whom received a combination of chemotherapy and biological therapy. Eighteen participants completed the study, while two did not finish. The trial was measuring two main things: how many participants' tumours responded to treatment (shrank or disappeared), and how many participants experienced significant side effects. The reported data shows that for the primary measure — tumour response — 12 out of 20 participants were counted as responders. This means their tumours either disappeared completely (called a "complete response") or shrank by at least 30% (called a "partial response"). The remaining 8 participants did not meet those response thresholds. For the secondary measure, the reported data shows that 18 out of 20 participants experienced at least one "Grade 3 or higher" side effect — meaning a serious or severe side effect as defined by a standard medical grading system used in clinical trials. It is worth noting that the results data as submitted does not separate out how many of the 12 responders had a complete response versus a partial response, so that breakdown is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00976911 · results posted 25 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 361 people — 182 in a chemotherapy-only group and 179 in a group receiving chemotherapy combined with a medicine called bevacizumab. The trial was studying women with a form of ovarian cancer that had returned after previous treatment. The main thing researchers were measuring was how long participants went without their disease getting worse (called "progression-free survival"), and they also tracked whether tumours shrank, how long those responses lasted, and how long participants lived overall. The reported data shows that, for the main measure, the median time before disease worsened or death occurred was 3.4 months in the chemotherapy-only group and 6.8 months in the chemotherapy-plus-bevacizumab group. By the November 2011 data cut-off, disease progression or death had been recorded in 92.3% of the chemotherapy-only group and 78.8% of the combination group. For the secondary measures, the reported data shows that 12.5% of participants in the chemotherapy-only group and 28.2% in the combination group had their tumours shrink meaningfully (a "complete" or "partial" response). Among those whose tumours did shrink, that response lasted a reported median of 5.4 months in the chemotherapy-only group and 9.4 months in the combination group. For the longer-term follow-up (data cut-off January 2013), the reported data shows that 75.8% of the chemotherapy-only group and 71.5% of the combination group had died by that point. The median length of time participants lived from the start of the trial was reported as 13.3 months in the chemotherapy-only group and 16.6 months in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00494442 · results posted 26 January 2015
According to the results reported on ClinicalTrials.gov, this trial looked at two different doses of a drug called olaparib — a lower dose (100 mg twice daily) and a higher dose (400 mg twice daily) — in people with a specific type of cancer. A total of 57 people took part: 24 in the lower-dose group and 33 in the higher-dose group. The main thing the trial was measuring was whether tumours visibly shrank or disappeared, using standard medical imaging scans and a recognised measuring system called RECIST. The reported data shows that in the lower-dose group, 3 out of 24 participants had their tumours shrink or disappear by a meaningful amount (meeting the RECIST criteria for a response). In the higher-dose group, 11 out of 33 participants met that same measure. For the additional measures, the reported data shows that around 45.5% of the lower-dose group and 71.0% of the higher-dose group experienced either a tumour response or their disease staying stable for at least 8 weeks. The best recorded reduction in tumour size was, on average, 5.1% for the lower-dose group and 25.8% for the higher-dose group. The reported length of time that a tumour response lasted was 242 days on average in the lower-dose group and 301 days in the higher-dose group. The time from starting treatment until the disease progressed or death was reported as 62.5 days for the lower-dose group and 226 days for 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 ↗
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NCT01015118 · results posted 15 January 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01015118) enrolled 1,366 participants in total — 911 received nintedanib and 455 received a placebo (an inactive treatment used for comparison). The trial was measuring how long people with ovarian cancer went without their disease getting worse (called "progression-free survival"), as well as how long people lived overall, and changes in a blood marker called CA-125 that can be associated with ovarian cancer activity. It is worth noting that only 242 participants in the nintedanib group and 128 in the placebo group were recorded as completing the study, meaning the majority left the trial early for various reasons. The reported data shows that, for the main measure — time without disease worsening based on the investigators' assessments — the median figure (the midpoint value across all participants) was 17.2 months for the nintedanib group and 16.6 months for the placebo group. In a follow-up analysis conducted later, those figures were 17.6 months and 16.6 months respectively. Using a slightly different measurement method for a secondary outcome, the reported medians were 18.3 months (nintedanib) versus 16.6 months (placebo), and 18.4 versus 16.6 months in the follow-up. For overall survival — how long people lived from the start of the trial — the reported median was 62.0 months in the nintedanib group and 62.8 months in the placebo group. For the CA-125 blood marker, the reported median time before it rose to a defined threshold was 16.6 months in the nintedanib group and 14.1 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01696994 · results posted 12 December 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01696994) enrolled a large number of women — approximately 39,111 in the control group (usual care, no special screening) and 39,105 in the ovarian screening group. The trial was measuring whether a screening program for ovarian cancer — which includes cancers of the ovaries, the nearby fallopian tubes, and a related lining called the peritoneum — made a difference to how many women died from those cancers, how many were diagnosed, and how many died from any cause at all. The reported data shows that the primary outcome — the number of ovarian cancer-related deaths — was 100 in the control group and 188 in the ovarian screening group. For deaths from all causes, the numbers were 3,542 in the control group and 3,508 in the screening group; when expressed as a rate (deaths per 10,000 person-years, meaning the number of deaths counted across all years each participant was followed), those figures were 92.6 and 91.9 respectively. The reported data also shows that 176 women in the control group and 212 in the screening group were diagnosed with ovarian cancer during the study, with diagnosis rates of 4.7 versus 5.7 per 10,000 person-years. Additionally, among those in the screening group who received a positive screening result, 226 positive screens were associated with complications arising from further medical investigation (such as follow-up tests or procedures); the data was only reported for the screening group for this outcome. It is worth noting that the number of participants recorded as completing the trial was noticeably lower than those who started — 33,919 of 39,111 in the control group and 30,668 of 39,105 in the screening group — meaning a portion of participants did not complete the study, though the reasons for this were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00114166 · results posted 26 June 2014
According to the results reported on ClinicalTrials.gov, this trial involved 81 people in total — 15 in one group receiving a lower dose of a medicine called topotecan (1.25 mg/m²), and 66 in a second group receiving a higher dose (4.0 mg/m²). The trial was measuring how tumours responded to treatment and tracking serious unwanted side effects (graded as level 3 or higher on a standard scale, meaning more severe reactions). The reported data shows that, for tumour response, in the lower-dose group: 4 participants had a complete response (all signs of tumours disappeared), 8 had a partial response (tumours shrank by at least 30%), 2 had disease progression (tumours grew), and 1 had stable disease (no clear change). In the higher-dose group: 8 had a complete response, 32 had a partial response, 21 had disease progression, and 4 had stable disease. Regarding serious side effects, the reported data shows varied numbers of participants in both groups experienced grade 3 or higher reactions across several categories, though the specific categories for each measurement were not labelled in the data provided, so a full breakdown cannot be given here. For the secondary outcome tracking why participants stopped treatment, the most common reason in both groups was disease progression (9 in the lower-dose group, 47 in the higher-dose group), with smaller numbers stopping due to other reasons such as side effects or other causes. 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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NCT00459290 · results posted 18 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom received the drug mifepristone. Of those, 19 completed the trial and 5 did not. The trial was looking at how mifepristone performed in people with a type of cancer (the specific cancer type was not detailed in the submitted data), measuring things like how long participants went without their cancer getting worse, whether tumours shrank or disappeared, and what side effects of grade 3 or higher (meaning more serious side effects) occurred. The reported data shows that approximately 13.6% of participants had not experienced their cancer getting worse at the 6-month mark. When it came to tumour responses — meaning tumours that either disappeared completely or shrank by at least 30% — the reported figure was 4.5% of participants. For the secondary outcome of how long participants went without their cancer progressing (called "progression-free survival"), the reported median time was 1.8 months overall. When participants were split into two groups based on how they had previously responded to a type of chemotherapy called platinum, the reported median progression-free survival was 1.7 months for those who were not platinum-sensitive and 1.9 months for those who were platinum-sensitive. The overall survival figure was listed in the data as "not available," meaning that result was not reported. Regarding more serious side effects (grade 3 or higher), the reported data shows that individual participants experienced a small number of such events, though the full breakdown by type was not provided in enough detail to describe each one separately. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00719186 · results posted 9 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 750 women across two groups — 376 received clomiphene citrate (a well-known fertility medicine) and 374 received letrozole (another medicine sometimes used to stimulate ovulation). All enrolled participants were recorded as completing the study. The trial was primarily measuring how many women went on to have a live birth, and also tracked pregnancies, ovulations, serious unwanted medical events, and complications in newborns. The reported data shows that, for the primary outcome of live birth, 72 out of 376 women in the clomiphene citrate group and 103 out of 374 women in the letrozole group had a live birth during the study period. For the secondary outcomes, the clomiphene citrate group recorded 103 pregnancies and 331 ovulations, while the letrozole group recorded 154 pregnancies and 388 ovulations. Regarding serious adverse events (that is, significant unwanted medical occurrences), 13 were reported in the clomiphene citrate group and 22 in the letrozole group. The reported data also includes neonatal complication figures (complications in newborns) across several categories, though the specific labels for each category were not included in the submitted data, so a full breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00866697 · results posted 19 December 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00866697) enrolled 940 women with ovarian cancer — 468 in the placebo group and 472 in the pazopanib 800 mg group. The trial was measuring how long participants went without their cancer getting worse (called progression-free survival), as well as how long participants lived overall, and how their quality of life changed over time. The reported data shows that, for the primary measure — time until the cancer progressed or death occurred — the placebo group had a median of 12.3 months and the pazopanib group had a median of 17.9 months. (Median means half the participants in each group reached that point before that time, and half after.) For overall survival, the reported median was 64.0 months in the placebo group and 59.1 months in the pazopanib group. Deaths were recorded in 215 out of 468 placebo participants and 231 out of 472 pazopanib participants. Using a slightly different method to measure progression-free survival (one that also includes a blood marker called CA-125), the reported figures were 11.9 months for placebo and 16.8 months for pazopanib. The three-year progression-free survival figures were listed as not available in the submitted data. For quality-of-life scores — measured on a 0–100 scale where higher means better — the reported data shows that across most time points measured, the pazopanib group's scores changed in the negative direction from their starting point (ranging from about −1.7 to −4.7), while the placebo group's scores stayed closer to their starting point or moved slightly positive. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00113607 · results posted 23 August 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 672 people in total — 335 in one group who received DOXIL alone, and 337 in a second group who received a combination of Trabectedin and DOXIL. The trial was designed to measure how long participants went without their disease getting worse (called "progression-free survival"), as well as overall survival, how many participants' tumours shrank or disappeared, and how long those responses lasted. The reported data also includes information about how the drug Trabectedin was absorbed into participants' bloodstreams. The reported data shows that, for the main measure — the time until disease got worse or death occurred — participants in the DOXIL-alone group had a median (middle value) of 5.8 months, compared to 7.3 months in the combination group. For overall survival (time from the start of the trial until death), the reported median was 18.9 months for the DOXIL-alone group and 22.2 months for the combination group. When looking at tumour response, the reported data shows that 18.8% of participants in the DOXIL-alone group had their tumours shrink or disappear, compared to 27.6% in the combination group. Among those whose tumours did respond, the response lasted a reported median of 7.7 months (DOXIL alone) and 7.9 months (combination). Two additional measurements relating to how Trabectedin moved through the body were also reported for the combination group only, but these are technical drug-level figures not directly related to how participants felt or fared. 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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NCT00093496 · results posted 10 July 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 29 people across two groups. The first group of 15 people had not previously been treated with a chemotherapy drug called gemcitabine, while the second group of 14 people had previously received gemcitabine. The trial was measuring how many participants showed a confirmed tumour response (meaning the tumour either disappeared completely or shrank by at least 30% on two separate check-ups at least four weeks apart), as well as how long it took for the disease to progress and how long participants survived overall. The reported data shows that in the group with no prior gemcitabine exposure, approximately 7.1% of participants (roughly 1 in 15) showed a confirmed tumour response, while in the group who had previously received gemcitabine, no participants showed a confirmed response. For time to progression — meaning how long before the disease was recorded as getting worse — the reported figures were 1.6 months for the no-prior-gemcitabine group and 2.7 months for the prior-gemcitabine group. For overall survival, the reported figures were 18.3 months for the first group and 11.5 months for the second group. Regarding side effects that were considered possibly, probably, or definitely related to the study treatment, 9 events were recorded in the first group and 7 in the second group, though a full breakdown of the types or severity of those events was not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00753545 · results posted 11 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 265 people — 136 received olaparib (400 mg twice daily) and 129 received a placebo (an inactive dummy treatment). The trial was measuring how long people lived without their cancer getting worse (called "progression-free survival"), as well as several other outcomes including overall survival, whether tumours shrank, and how long any shrinkage lasted. The reported data shows that, for the main outcome, people in the olaparib group went a median (middle value) of 8.4 months before their cancer progressed or they died, compared to 4.8 months in the placebo group. For overall survival — how long people lived in total — the reported median was 29.8 months in the olaparib group and 27.8 months in the placebo group. When looking at whether tumours visibly shrank, 12.3% of participants in the olaparib group had a recorded reduction, compared to 4.2% in the placebo group. The "disease control rate" — meaning stable or reduced disease for at least around 24 weeks — was reported as 53.7% for olaparib and 25.6% for placebo. For tumour size change at 24 weeks, the olaparib group showed an average reduction of 0.8%, while the placebo group showed an average increase of 26.4%. The reported median duration of response (how long a shrinkage lasted) was 4.2 months for olaparib and 2.3 months for placebo, though the trial notes there were too few responses to draw firm conclusions from these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01081951 · results posted 10 December 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 81 participants in each of two groups — 162 people in total. One group received a combination of three medicines: olaparib, carboplatin (at a dose level called AUC4), and paclitaxel. The other group received the more standard two-medicine combination of carboplatin (at a higher dose level, AUC6) and paclitaxel. The trial was primarily measuring how long participants went without their disease getting worse — known as "progression-free survival" — and also tracked overall survival (how long participants lived) and changes in tumour size. The reported data shows that, on average, participants in the olaparib/carboplatin/paclitaxel group went 12.2 months before their disease progressed or they passed away, compared with 9.6 months in the standard carboplatin/paclitaxel group. For overall survival, the data records the number of deaths that had occurred by the final analysis date: 54 deaths in the olaparib combination group and 47 deaths in the standard group. Regarding tumour size, both groups showed a reduction at the nine-week mark — the olaparib combination group had an average decrease of 38.4%, while the standard group had an average decrease of 39.1%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01012336 · results posted 10 October 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 85 participants, all of whom completed the study with no dropouts. The trial was looking at a three-drug combination — aprepitant, ramosetron, and dexamethasone — given to people receiving chemotherapy. The main things being measured were how many participants had a "complete response" (meaning no vomiting and no need for extra anti-nausea medication) in the 120 hours — about five days — after chemotherapy began, as well as the safety and tolerability of the drug combination. The reported data shows that 89.4% of participants had a complete response over that 120-hour period. This figure covers the overall timeframe from the start of chemotherapy through to the morning of day six. The trial also intended to report on safety and tolerability, as well as secondary measures such as the proportion of participants who had no vomiting at all and the time until a first vomiting episode or need for rescue medication — however, the numbers for these outcomes were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00293293 · results posted 6 June 2012
According to the results reported on ClinicalTrials.gov, this trial involved 43 women with ovarian cancer — 20 in a group receiving chemotherapy alone, and 23 in a group receiving chemotherapy combined with complementary and alternative medicine (CAM). The trial was measuring quality of life and mental wellbeing across multiple chemotherapy cycles, using two standard questionnaires: the FACT-O (a quality-of-life tool specifically for ovarian cancer patients) and the Mental Health Inventory (MHI). Of the 43 who started, 39 completed the study — 18 in the chemotherapy-alone group and 21 in the chemotherapy-plus-CAM group. The reported data shows that FACT-O scores (where a higher number means a greater reported impact on quality of life, on a scale of 0–200) were measured at four points across the trial. For the chemotherapy-alone group, the scores were 143, 154, 158, and 173 across those time points. For the chemotherapy-plus-CAM group, the scores were 152, 152, 152, and 162. For the MHI (where higher scores indicate better mental wellbeing, on a scale of 38–240), the chemotherapy-alone group recorded 195, 182, 196, and 203, while the chemotherapy-plus-CAM group recorded 191, 189, 197, and 187 across the same time points. The reported data also shows some secondary measurements. In the chemotherapy-alone group, 8 out of 20 participants had to delay their treatment due to side effects, compared with 7 out of 23 in the CAM group. On average, participants in the chemotherapy-alone group used 4.75 anti-nausea medication prescriptions each, while those in the chemotherapy-plus-CAM group used an average of 5.95. 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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NCT00805935 · results posted 25 January 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in total, divided across four groups. Each group received a different combination of fertility stimulation medication (either menotropin or follitropin beta) and a type of progesterone support (either a vaginal insert or an oil injection). The trial was primarily looking at how many participants had their treatment cycle cancelled because of a concern about a condition called ovarian hyperstimulation syndrome (OHSS) — a potential complication where the ovaries over-respond to fertility medication. The reported data shows that very few cycle cancellations due to OHSS risk were recorded: one cancellation in the menotropin/vaginal insert group, one in the follitropin beta/vaginal insert group, and none in either of the oil injection groups. For the secondary measurements — which looked at what happened during and after the stimulation process — the reported data shows that on average, around 27.7 follicles (fluid-filled sacs in the ovaries that contain eggs) were observed in the menotropin group and 30.5 in the follitropin beta group. The average number of eggs collected was 13.0 for menotropin and 15.6 for follitropin beta. The reported fertilisation rate (the percentage of collected eggs that were fertilised) was 17.1% for menotropin and 24.8% for follitropin beta. On average, 2.0 early-stage embryos were transferred in both medication groups, and approximately 1.9 embryos on average were frozen for potential future use in both groups. It is worth noting that a notable number of participants did not complete the study — between 8 and 19 people dropped out across the four groups — though the reasons for this are not fully detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00434642 · results posted 3 November 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 484 people in total — 242 in each group. All participants had a form of cancer and were receiving a chemotherapy combination of carboplatin and gemcitabine. One group also received a medicine called bevacizumab, while the other group received a placebo (a dummy treatment with no active ingredient) alongside the same chemotherapy. The main thing the trial was measuring was how long participants went before their cancer showed signs of growing or spreading — a period known as "progression-free survival." The reported data shows that, on average, participants in the bevacizumab group went approximately 12.4 months before their cancer progressed, compared with approximately 8.4 months in the placebo group. For a secondary measure — the proportion of participants whose tumours shrank by a meaningful amount — the reported figures were 78.5% in the bevacizumab group and 57.4% in the placebo group. Among those whose tumours did shrink, that response lasted an average of around 10.4 months in the bevacizumab group and 7.4 months in the placebo group. The reported data also shows that overall survival (time from the start of the trial to death from any cause) was approximately 33.6 months in the bevacizumab group and 32.9 months in the placebo group. No cases of gastrointestinal perforation (a hole forming in the stomach or bowel wall) were reported in either group. The reported data shows that 100% of participants in both groups experienced at least one unwanted side effect of some kind, though the data submitted does not break down the nature or severity of those events 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.
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NCT00429403 · results posted 26 July 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00429403) set out to compare two groups of participants — one receiving a medicine called goserelin and one receiving no goserelin — to look at signs of ovarian function recovery after chemotherapy. Specifically, it was measuring a combination of two things: levels of a hormone called FSH (follicle-stimulating hormone, which plays a role in the menstrual cycle) and whether vaginal bleeding returned within 12 months of finishing chemotherapy. The trial enrolled only 1 participant in the goserelin group and no participants in the "no goserelin" group. The reported data shows that because so few people took part — just one person in total — the results are extremely limited. For the primary outcome (the combined measure of hormone levels and return of vaginal bleeding), only one result was recorded, from the single participant in the goserelin group. No data was reported for the "no goserelin" group, as no one was enrolled in it. Secondary outcome data was not reported in the results submitted to ClinicalTrials.gov. Given that only one person participated, the reported data does not provide a meaningful basis for drawing any conclusions about goserelin or its 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.
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NCT00281632 · results posted 4 January 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people, all of whom received a daily oral dose of pazopanib (800 mg) for recurrent ovarian cancer. The trial was measuring how the drug affected a blood marker called CA-125, which is commonly monitored in ovarian cancer. Notably, none of the 36 participants were recorded as having "completed" the study — all 36 were listed under "not completed," though the data does not explain the reasons for this in detail. The reported data shows that for the main outcome — whether CA-125 levels dropped by at least 50% — 6% of participants met that threshold. Looking at broader disease status categories, 25% were recorded as having stable disease, 56% as having progressive disease (meaning their CA-125 continued to rise), and smaller percentages fell into other categories. Among the smaller group of participants who did show that 50% or greater CA-125 reduction, the reported data shows it took a median (middle value) of 29 days to first reach that reduction, and that reduction lasted a median of 113 days before signs of progression appeared. For one secondary outcome — whether CA-125 doubled during treatment — the investigators reported that no participant's CA-125 doubled from their starting level, so no figures were provided for that measure. The reported data also shows results for overall response when combining blood marker, scan, and clinical assessments together. Across all 36 participants, approximately 2.8% showed an overall response, around 16.7% showed partial response, roughly 22.2% showed stable disease, and about 55.6% showed progressive disease. When looking at how long participants went without their disease progressing (progression-free survival), the reported median was 168 days for those who had shown a CA-125 response, 57 days for those who had not, and 84 days across all participants combined. 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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NCT00331422 · results posted 8 February 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 7 people, all of whom received the study treatment. Of those 7, only 2 completed the trial, while 5 did not complete it. The trial was measuring how patients with ovarian cancer responded to chemotherapy given before surgery — specifically looking at whether tumours could be surgically removed after treatment, how tumours changed in size, and how a blood marker called CA-125 (a substance that can be raised in some cancers) changed over time. The reported data shows that 2 of the participants went on to have surgery after completing 4 cycles of chemotherapy, and these were the only participants counted for the main goal of the trial. For tumour size changes — measured using a standard set of criteria called RECIST — the reported data shows 2 participants had a partial response (meaning their tumours shrank by 30% or more), 3 had stable disease (meaning tumours neither shrank nor grew significantly), and 2 had a progressive disease response (meaning tumours grew or new ones appeared). For the CA-125 blood marker, the reported data shows 1 participant had a decrease (which the trial defined as a clinical response), while 6 did not show this decrease. Several other planned measurements — including tests on drug resistance, specific tumour proteins, and quality of life questionnaires — were not able to be completed or reported, due to tissue samples being unsuitable or participants not consistently filling in the questionnaires. The data for those outcomes was not reported. It is worth noting that with only 7 participants, this was a very small trial, and the reported numbers reflect a limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00089141 · results posted 26 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people in total — 74 received the drug mycophenolate mofetil and 77 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether adding mycophenolate mofetil to standard treatment could lead to a complete resolution of chronic graft-versus-host disease (a condition that can occur after a bone marrow or stem cell transplant, where the donor's cells attack the recipient's body) without needing to use additional medicines. By the end of the study, 56 people in the mycophenolate mofetil group and 53 in the placebo group had completed the trial. The reported data shows that for the main question the trial was asking — how many people had their chronic graft-versus-host disease fully resolve without needing extra treatment — 11 out of 74 people in the mycophenolate mofetil group and 10 out of 77 in the placebo group reached that outcome. For the secondary measures, the trial also tracked less favourable outcomes. The reported data shows that 45 people in the mycophenolate mofetil group and 40 in the placebo group experienced what the researchers called a "definitive absence of efficacy success," meaning their disease did not respond well enough, or they died, or their original illness came back. Specifically, 24 people in the mycophenolate mofetil group and 25 in the placebo group needed additional open-label (non-blinded) systemic treatment due to an inadequate response. The reported data also shows that a lung complication called bronchiolitis obliterans (scarring of the small airways) developed in 5 people in the mycophenolate mofetil group and 4 in the placebo group. The original illness returned in 17 people in the mycophenolate mofetil group compared with 10 in the placebo group, and 8 people in the mycophenolate mofetil group and 5 in the placebo group died without their illness having returned beforehand. 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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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.