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Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
NCT01936363 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01936363
The ClinicalTrials.gov registry entry for NCT01936363 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01936363 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01936363?
This trial is sponsored by EMD Serono, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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