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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Sarcoma

Treatments: Drug: Placebo; Drug: OMBRABULIN (AVE8062)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699517

EudraCT 2007-003592-39

EFC10145

Details and patient eligibility

About

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.

Enrollment: 355 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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355 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: OMBRABULIN (AVE8062)

2

Placebo Comparator group

Treatment:

Drug: Placebo