A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
- Registration Number
- NCT00699517
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms
The secondary objectives of the study are :
* To compare the overall survival in the 2 treatment arms
* To compare the objective response rate in the 2 treatment arms
* To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
* To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 OMBRABULIN (AVE8062) -
- Primary Outcome Measures
Name Time Method Progression free survival until event or study cut-off date (Tumor assessment every 6 weeks)
- Secondary Outcome Measures
Name Time Method Overall survival until event or study cut-off date Response rate tumor assessment every 6 weeks Safety profile assessment every 3 weeks
Trial Locations
- Locations (45)
Investigational Site Number 840005
🇺🇸Maywood, Illinois, United States
Investigational Site Number 840004
🇺🇸Santa Monica, California, United States
Investigational Site Number 840007
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 076007
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 076008
🇧🇷Goiania, Brazil
Investigational Site Number 250003
🇫🇷Saint Cloud, France
Investigational Site Number 356005
🇮🇳Bangalore, India
Investigational Site Number 724001
🇪🇸Madrid, Spain
Investigational Site Number 724004
🇪🇸Barcelona, Spain
Investigational Site Number 826001
🇬🇧Bebington, United Kingdom
Investigational Site Number 724003
🇪🇸Pamplona, Spain
Investigational Site Number 826003
🇬🇧Bristol, United Kingdom
Investigational Site Number 826002
🇬🇧Newcastle Upon Tyne, United Kingdom
Investigational Site Number 840002
🇺🇸Newark, New Jersey, United States
Investigational Site Number 840003
🇺🇸Orlando, Florida, United States
Investigational Site Number 056001
🇧🇪Bruxelles, Belgium
Investigational Site Number 056004
🇧🇪Haine-Saint-Paul, Belgium
Investigational Site Number 056005
🇧🇪Liège, Belgium
Investigational Site Number 076003
🇧🇷Ijui, Brazil
Investigational Site Number 076004
🇧🇷Jau, Brazil
Investigational Site Number 076006
🇧🇷Novo Hamburgo, Brazil
Investigational Site Number 076002
🇧🇷Porto Alegre, Brazil
Investigational Site Number 250004
🇫🇷Lille, France
Investigational Site Number 076005
🇧🇷Porto Alegre, Brazil
Investigational Site Number 076009
🇧🇷Rio De Janeiro, Brazil
Investigational Site Number 250008
🇫🇷Bordeaux, France
Investigational Site Number 250002
🇫🇷Dijon, France
Investigational Site Number 250001
🇫🇷Lyon Cedex 03, France
Investigational Site Number 250010
🇫🇷Marseille, France
Investigational Site Number 250006
🇫🇷Montpellier Cedex, France
Investigational Site Number 250007
🇫🇷Nice Cedex 02, France
Investigational Site Number 250005
🇫🇷Rennes, France
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 250012
🇫🇷Saint Priest En Jarez, France
Investigational Site Number 250009
🇫🇷Saint-Herblain, France
Investigational Site Number 380004
🇮🇹Milano, Italy
Investigational Site Number 380002
🇮🇹Rozzano, Italy
Investigational Site Number 891001
🇷🇸Belgrade, Serbia
Investigational Site Number 891002
🇷🇸Sremska Kamenica, Serbia
Investigational Site Number 348002
🇭🇺Debrecen, Hungary
Investigational Site Number 356003
🇮🇳Hyderabad, India
Investigational Site Number 356004
🇮🇳New Delhi, India
Investigational Site Number 380001
🇮🇹Aviano, Italy
Investigational Site Number 380003
🇮🇹Milano, Italy
Investigational Site Number 840001
🇺🇸San Antonio, Texas, United States