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NCT01936363 · ClinicalTrials.gov registry record · Phase 2
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
A Phase 2 study of Ovarian Cancer, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT01936363: Completed Phase 2 study of Ovarian Cancer, sponsored by EMD Serono.
NCT01936363 is a Phase 2 study of Ovarian Cancer that has completed, run by EMD Serono. The registered enrollment target is 65 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01936363, a Phase 2 study of Ovarian Cancer, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG SAR245409
- DRUG Pimasertib once daily
- DRUG Pimasertib placebo
- DRUG SAR245409 placebo
- DRUG Pimasertib twice daily
Study Locations (20)
Ohio
- Research site - Cincinnati
- Research site - Columbus
- Research site - Middletown
Massachusetts
- Research site - Boston
- Research site - Boston
Michigan
- Research site - Ann Arbor
- Research site - Detroit
Missouri
- Research site - Kansas City
- Research site - St Louis
Georgia
- Research site - Augusta
Illinois
- Research site - Chicago
Indiana
- Research site - Indianapolis
Maryland
- Research site - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 2 |
What the finished NCT01936363 record still lists
NCT01936363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which SAR245409 is the first listed.
NCT01936363 names 20 study sites across 15 states, led by Ohio, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT01936363 about?
NCT01936363 is a clinical study titled "Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer". This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administere...
What is the current status of trial NCT01936363?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2013-09-30. Estimated completion is 2017-11-30.
What conditions does trial NCT01936363 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT01936363?
The interventions under investigation include: SAR245409 (DRUG), Pimasertib once daily (DRUG), Pimasertib placebo (DRUG), SAR245409 placebo (DRUG), Pimasertib twice daily (DRUG).
Who is sponsoring clinical trial NCT01936363?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01936363 being conducted?
This trial has 20 study locations across Georgia, Illinois, Indiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01936363's enrollment target sits among peer trials
65 187th of 322 higher than 136 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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