Trials / Completed
CompletedNCT01332656
Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Treatment will continue until disease progression or unacceptable toxicity or consent withdrawal. A minimum of 6 cycles of the combined therapies should be administered, unless progression occurs before or safety reasons cause the discontinuation of one or two drugs of the combination therapies. In case of no progression, it will be investigator's decision to continue or not the study treatment after 6 cycles according to his clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2011-04-11
- Last updated
- 2015-12-21
Locations
38 sites across 10 countries: United States, Belgium, Czechia, France, Germany, Italy, Poland, Russia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT01332656. Inclusion in this directory is not an endorsement.