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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 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.

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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.

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

FieldValue
Enrollment Target 65 participants
Start Date 2013-09-30
Est. Completion 2017-11-30
Phase Phase 2

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT01936363

The ClinicalTrials.gov registry entry for NCT01936363 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower). The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.