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Brief Title: A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
Official Title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.
Study ID: NCT00699517
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site Number 840004, Santa Monica, California, United States
Investigational Site Number 840003, Orlando, Florida, United States
Investigational Site Number 840005, Maywood, Illinois, United States
Investigational Site Number 840002, Newark, New Jersey, United States
Investigational Site Number 840007, Philadelphia, Pennsylvania, United States
Investigational Site Number 840001, San Antonio, Texas, 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 076007, Belo Horizonte, , Brazil
Investigational Site Number 076008, Goiania, , Brazil
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 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 250004, Lille, , 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 250003, Saint Cloud, , France
Investigational Site Number 250012, Saint Priest En Jarez, , France
Investigational Site Number 250009, Saint-Herblain, , France
Investigational Site Number 348001, Budapest, , Hungary
Investigational Site Number 348002, Debrecen, , Hungary
Investigational Site Number 356005, Bangalore, , India
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 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 724004, Barcelona, , Spain
Investigational Site Number 724001, Madrid, , Spain
Investigational Site Number 724003, Pamplona, , Spain
Investigational Site Number 826001, Bebington, , United Kingdom
Investigational Site Number 826003, Bristol, , United Kingdom
Investigational Site Number 826002, Newcastle Upon Tyne, , United Kingdom
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR