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Spots Global Cancer Trial Database for A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

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Trial Identification

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

Conditions

Sarcoma

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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