Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
- Conditions
- Ovarian Cancer Recurrent
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 154
Not provided
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
๐บ๐ธBoston, Massachusetts, United States
Investigational Site Number 203004
๐จ๐ฟZlin, Czech Republic
Investigational Site Number 643003
๐ท๐บMoscow, Russian Federation
Investigational Site Number 724003
๐ช๐ธMadrid, Spain
Investigational Site Number 380001
๐ฎ๐นRoma, Italy
Investigational Site Number 616005
๐ต๐ฑWarszawa, Poland
Investigational Site Number 056002
๐ง๐ชHaine-Saint-Paul, Belgium
Investigational Site Number 616003
๐ต๐ฑRybnik, Poland
Investigational Site Number 616001
๐ต๐ฑWarszawa, Poland
Investigational Site Number 203002
๐จ๐ฟOlomouc, Czech Republic
Investigational Site Number 840001
๐บ๐ธNew Haven, Connecticut, United States
Investigational Site Number 056003
๐ง๐ชNamur, Belgium
Investigational Site Number 056001
๐ง๐ชLeuven, Belgium
Investigational Site Number 203003
๐จ๐ฟNovy Jicin, Czech Republic
Investigational Site Number 643004
๐ท๐บSaint-Petersburg, Russian Federation
Investigational Site Number 643001
๐ท๐บMoscow, Russian Federation
Investigational Site Number 804004
๐บ๐ฆKharkov, Ukraine
Investigational Site Number 643002
๐ท๐บMoscow, Russian Federation
Investigational Site Number 056005
๐ง๐ชKortrijk, Belgium
Investigational Site Number 840007
๐บ๐ธBurbank, California, United States
Investigational Site Number 840202
๐บ๐ธFort Meyers, Florida, United States
Investigational Site Number 840009
๐บ๐ธAtlanta, Georgia, United States
Investigational Site Number 203001
๐จ๐ฟPraha 2, Czech Republic
Investigational Site Number 250004
๐ซ๐ทCaen Cedex 05, France
Investigational Site Number 250006
๐ซ๐ทBordeaux, France
Investigational Site Number 250001
๐ซ๐ทLyon, France
Investigational Site Number 276001
๐ฉ๐ชMรผnchen, Germany
Investigational Site Number 250002
๐ซ๐ทParis Cedex 4, France
Investigational Site Number 380004
๐ฎ๐นGenova, Italy
Investigational Site Number 250003
๐ซ๐ทVillejuif, France
Investigational Site Number 380003
๐ฎ๐นMilano, Italy
Investigational Site Number 616002
๐ต๐ฑKrakow, Poland
Investigational Site Number 616004
๐ต๐ฑPoznan, Poland
Investigational Site Number 804005
๐บ๐ฆDonetsk, Ukraine
Investigational Site Number 724001
๐ช๐ธMadrid, Spain
Investigational Site Number 724002
๐ช๐ธBarcelona, Spain
Investigational Site Number 804003
๐บ๐ฆDnipropetrovsk, Ukraine
Investigational Site Number 804002
๐บ๐ฆLviv, Ukraine