A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

Completed · Phase 3 · Has a placebo group

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT00699517

Run by

Sanofi

People needed

355

Starts

2008-06-01

Expected to finish

2013-04-01

Last updated by the study team

2015-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven soft tissue sarcoma
• Unresectable locoregional recurrent or metastatic soft tissue sarcoma
• Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy

You may not qualify if…

• Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
• Brain metastases and carcinomatous leptomeningitis
• Uncontrolled hypertension
• Known platinum hypersensitivity
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• 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 — Brussels, 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 — Goiânia, Brazil
• Investigational Site Number 076003 — Ijuí, Brazil
• Investigational Site Number 076004 — Jaú, 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, France
• Investigational Site Number 250010 — Marseille, France
• Investigational Site Number 250006 — Montpellier, France
• Investigational Site Number 250007 — Nice, France
• Investigational Site Number 250005 — Rennes, France

Full record on ClinicalTrials.gov

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