Trial · NCT01936363
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
NCT01936363, Phase 2, Completed, EMD Serono; results first posted 2017-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer. Trials, record NCT01936363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01936363
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
- NCT number
- NCT01936363
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Ovarian Cancer
- Interventions
- Pimasertib once daily, Pimasertib placebo, SAR245409 placebo, SAR245409, Pimasertib twice daily
- First posted
- 2013-09-06
- Last updated
- 2018-12-12
- Other registries' IDs
- eudract:2013-000902-40
- Results first posted
- 2017-04-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Tumor Response | From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months | Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (\<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression-Free Survival | Time from randomization until first observation of progressive disease or death, assessed up to 52 months | PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley. |
| Secondary | Percentage of Participants With Disease Control | Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months | Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. |
| Secondary | Overall Survival | Time from randomization until death, assessed up to 52 months | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants. |
| Secondary | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) | Baseline up to disease progression or withdrawal, assessed up to 52 months | EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28) | Baseline up to disease progression or withdrawal, assessed up to 52 months | EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death | First dose of study drug up to 52 months | TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 | |
| Secondary | Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 | |
| Secondary | Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood | Screening visit (day -28 to 1) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Tumor Response | From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months | ITT analysis set included all participants who had been randomized. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival | Time from randomization until first observation of progressive disease or death, assessed up to 52 months | ITT analysis set included all participants who had been randomized. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control | Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months | ITT analysis set included all participants who had been randomized. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Time from randomization until death, assessed up to 52 months | ITT analysis set included all participants who had been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) | Baseline up to disease progression or withdrawal, assessed up to 52 months | Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued. | ||
| SECONDARY | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28) | Baseline up to disease progression or withdrawal, assessed up to 52 months | Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued. | ||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death | First dose of study drug up to 52 months | Safety population (SAF) analysis set included all participants who received at least one dose of any trial treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | ||
| SECONDARY | Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | ||
| SECONDARY | Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood | Screening visit (day -28 to 1) | As per changed in planned analysis the outcome measure related to pharmacodynamics parameters was not assessed. |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Tumor Response | Pimasertib (Once Daily) Plus SAR245409 | 12.5 | 95% Confidence Interval 3.5 to 29.0 | percentage of participants | |
| Objective Tumor Response | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 12.1 | 95% Confidence Interval 3.4 to 28.2 | percentage of participants | |
| Progression-Free Survival | Pimasertib (Once Daily) Plus SAR245409 | 9.99 | 95% Confidence Interval 3.42 to 15.21 | months | |
| Progression-Free Survival | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 12.71 | 95% Confidence Interval 4.21 to NA | months | |
| Percentage of Participants With Disease Control | Pimasertib (Once Daily) Plus SAR245409 | 50.0 | 95% Confidence Interval 31.9 to 68.1 | percentage of participants | |
| Percentage of Participants With Disease Control | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 39.4 | 95% Confidence Interval 22.9 to 57.9 | percentage of participants | |
| Overall Survival | Pimasertib (Once Daily) Plus SAR245409 | Number of deaths | 8 | Participants | |
| Overall Survival | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Number of deaths | 6 | Participants | |
| Overall Survival | Pimasertib (Once Daily) Plus SAR245409 | Number for censored | 24 | Participants | |
| Overall Survival | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Number for censored | 27 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pimasertib (Once Daily) Plus SAR245409 | 32 | |
| Overall Study | STARTED | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 33 | |
| Overall Study | COMPLETED | Pimasertib (Once Daily) Plus SAR245409 | 32 | |
| Overall Study | COMPLETED | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 33 | |
| Overall Study | NOT COMPLETED | Pimasertib (Once Daily) Plus SAR245409 | 0 | |
| Overall Study | NOT COMPLETED | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 0 |
Source ClinicalTrials.gov
Adverse events342
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pimasertib (Once Daily) Plus SAR245409 | 7 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 5 | 32 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Pimasertib (Once Daily) Plus SAR245409 | 2 | 32 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 0 | 32 | |
| other | Palpitations | Cardiac disorders | Pimasertib (Once Daily) Plus SAR245409 | 2 | 32 | |
| other | Palpitations | Cardiac disorders | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 0 | 32 | |
| other | Tachycardia | Cardiac disorders | Pimasertib (Once Daily) Plus SAR245409 | 2 | 32 | |
| other | Tachycardia | Cardiac disorders | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 0 | 32 | |
| other | Vision blurred | Eye disorders | Pimasertib (Once Daily) Plus SAR245409 | 16 | 32 | |
| other | Vision blurred | Eye disorders | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 11 | 32 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pimasertib (Once Daily) Plus SAR245409 | ||
| Total, all-cause mortality | Pimasertib (Twice Daily) Plus SAR245409 Placebo | ||
| Total, other adverse events | Pimasertib (Once Daily) Plus SAR245409 | 32 | 32 |
| Total, other adverse events | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 32 | 32 |
| Total, serious adverse events | Pimasertib (Once Daily) Plus SAR245409 | 16 | 32 |
| Total, serious adverse events | Pimasertib (Twice Daily) Plus SAR245409 Placebo | 18 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pimasertib (Once Daily) Plus SAR245409 vs Pimasertib (Twice Daily) Plus SAR245409 Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01936363
GET https://conductscience.org/api/trials/v1/NCT01936363/events?page=2