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NCT01332656 · ClinicalTrials.gov registry record · Phase 2

Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

A Phase 2 study of Ovarian Cancer Recurrent, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
154
Enrollment target
20
Study locations

NCT01332656: Completed Phase 2 study of Ovarian Cancer Recurrent, sponsored by Sanofi.

NCT01332656 is a Phase 2 study of Ovarian Cancer Recurrent that has completed, run by Sanofi. The registered enrollment target is 154 participants, above the 99-participant average among 4 other Ovarian Cancer Recurrent trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01332656, a Phase 2 study of Ovarian Cancer Recurrent, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
154 participants
Enrollment target
20
Study locations

Study Summary

Primary Objective: \- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin. Secondary Objectives: * To compare the overall survival (OS) between the 2 treatment arms * To compare the objective response rate (RR) between the 2 treatment arms

Conditions Studied

Ovarian Cancer Recurrent

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Paclitaxel
  • DRUG Ombrabulin (AVE8062)

Study Locations (20)

Other

  • Investigational Site Number 056002 - Haine-Saint-Paul
  • Investigational Site Number 056005 - Kortrijk
  • Investigational Site Number 056001 - Leuven
  • Investigational Site Number 056003 - Namur
  • Investigational Site Number 203003 - Nový Jičín
  • Investigational Site Number 203002 - Olomouc
  • Investigational Site Number 203001 - Prague
  • Investigational Site Number 203004 - Zlín
  • Investigational Site Number 250006 - Bordeaux
  • Investigational Site Number 250004 - Caen
  • Investigational Site Number 250001 - Lyon
  • Investigational Site Number 250002 - Paris
  • Investigational Site Number 250003 - Villejuif
  • Investigational Site Number 276001 - München
  • Investigational Site Number 380004 - Genova

California

  • Investigational Site Number 840007 - Burbank

Connecticut

  • Investigational Site Number 840001 - New Haven

Florida

  • Investigational Site Number 840202 - Fort Meyers

Georgia

  • Investigational Site Number 840009 - Atlanta

Massachusetts

  • Investigational Site Number 840002 - Boston

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2011-05
Est. Completion 2014-07
Phase Phase 2
Sanofi

713 total trials

What the finished NCT01332656 record still lists

NCT01332656 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 4 other Ovarian Cancer Recurrent trials with a reported enrollment target (56% higher).

The record links to 1 condition, with Ovarian Cancer Recurrent appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.

NCT01332656 names 20 study sites across 6 states, led by Other, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01332656 about?

NCT01332656 is a clinical study titled "Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel". Primary Objective: \- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin. Secondary Objectives: * To compare the overall survival (OS) between the ...

What is the current status of trial NCT01332656?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2011-05. Estimated completion is 2014-07.

What conditions does trial NCT01332656 study?

This clinical trial studies the following conditions: Ovarian Cancer Recurrent.

What interventions are being tested in trial NCT01332656?

The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Paclitaxel (DRUG), Ombrabulin (AVE8062) (DRUG).

Who is sponsoring clinical trial NCT01332656?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01332656 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01332656, the US trial registry maintained by the National Library of Medicine. NCT01332656 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.