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

NCT01332656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2015-12-21

No results posted yet for this 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

  • Ovarian Cancer Recurrent

Interventions

DRUG

Ombrabulin (AVE8062)

Pharmaceutical form:solution Route of administration: intravenous

DRUG

Placebo

Pharmaceutical form:solution Route of administration: intravenous

DRUG

Paclitaxel

Pharmaceutical form:solution Route of administration: intravenous

DRUG

Carboplatin

Pharmaceutical form:solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332656 on ClinicalTrials.gov