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

Phase 2

Completed

• Conditions: Ovarian Cancer Recurrent
• Interventions: Drug: Placebo; Drug: Ombrabulin (AVE8062); Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT01332656
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Study Start: 2011-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-11
• Disposition First Submitted: 2015-11-18
• Disposition First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Disposition First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Paclitaxel	Placebo, Paclitaxel and Carboplatin
Arm B	Placebo	Placebo, Paclitaxel and Carboplatin
Arm A	Ombrabulin (AVE8062)	Ombrabulin, Paclitaxel and Carboplatin
Arm A	Paclitaxel	Ombrabulin, Paclitaxel and Carboplatin
Arm A	Carboplatin	Ombrabulin, Paclitaxel and Carboplatin
Arm B	Carboplatin	Placebo, Paclitaxel and Carboplatin

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	approximately 24 months
Objective Response Rate (RR)	approximately 24 months

Trial Locations

Locations (38)

Investigational Site Number 840002; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 203004; 🇨🇿 Zlin, Czech Republic

Investigational Site Number 643003; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 724003; 🇪🇸 Madrid, Spain

Investigational Site Number 380001; 🇮🇹 Roma, Italy

Investigational Site Number 616005; 🇵🇱 Warszawa, Poland

Investigational Site Number 056002; 🇧🇪 Haine-Saint-Paul, Belgium

Investigational Site Number 616003; 🇵🇱 Rybnik, Poland

Investigational Site Number 616001; 🇵🇱 Warszawa, Poland

Investigational Site Number 203002; 🇨🇿 Olomouc, Czech Republic

Investigational Site Number 840001; 🇺🇸 New Haven, Connecticut, United States

Investigational Site Number 056003; 🇧🇪 Namur, Belgium

Investigational Site Number 056001; 🇧🇪 Leuven, Belgium

Investigational Site Number 203003; 🇨🇿 Novy Jicin, Czech Republic

Investigational Site Number 643004; 🇷🇺 Saint-Petersburg, Russian Federation

Investigational Site Number 643001; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 804004; 🇺🇦 Kharkov, Ukraine

Investigational Site Number 643002; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 056005; 🇧🇪 Kortrijk, Belgium

Investigational Site Number 840007; 🇺🇸 Burbank, California, United States

Investigational Site Number 840202; 🇺🇸 Fort Meyers, Florida, United States

Investigational Site Number 840009; 🇺🇸 Atlanta, Georgia, United States

Investigational Site Number 203001; 🇨🇿 Praha 2, Czech Republic

Investigational Site Number 250004; 🇫🇷 Caen Cedex 05, France

Investigational Site Number 250006; 🇫🇷 Bordeaux, France

Investigational Site Number 250001; 🇫🇷 Lyon, France

Investigational Site Number 276001; 🇩🇪 München, Germany

Investigational Site Number 250002; 🇫🇷 Paris Cedex 4, France

Investigational Site Number 380004; 🇮🇹 Genova, Italy

Investigational Site Number 250003; 🇫🇷 Villejuif, France

Investigational Site Number 380003; 🇮🇹 Milano, Italy

Investigational Site Number 616002; 🇵🇱 Krakow, Poland

Investigational Site Number 616004; 🇵🇱 Poznan, Poland

Investigational Site Number 804005; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 724001; 🇪🇸 Madrid, Spain

Investigational Site Number 724002; 🇪🇸 Barcelona, Spain

Investigational Site Number 804003; 🇺🇦 Dnipropetrovsk, Ukraine

Investigational Site Number 804002; 🇺🇦 Lviv, Ukraine