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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III, Phase II

Treatment

Active

18 and over

Pharmaceutical / Industry

EFC10145
AVE8062, EudraCT 2007-003592-39, NCT00699517

Trial Description

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.

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

ICD

Study Director

Public Registry ICD
		Email: GV-Contact-us@sanofi-aventis.com

Trial Sites

U.S.A.

New Jersey

Bridgewater

Sanofi-Aventis - US - Bridgewater

Contact Person

Email: GV-Contact-us@sanofi-aventis.com

Belgium

Diegem

Sanofi-Aventis Belgium

Contact Person

Email: GV-Contact-us@sanofi-aventis.com

France

Paris

Sanofi-Aventis France

Contact Person

Email: GV-Contact-us@sanofi-aventis.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00699517
Information obtained from ClinicalTrials.gov on September 22, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.