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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Ifosfamide; Isophosphamide mustard

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.