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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: OMBRABULIN (AVE8062)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: OMBRABULIN (AVE8062)<br>* I.V. infusion followed by administration of cisplatin<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* I.V. infusion followed by administration of cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | until event or study cut-off date (Tumor assessment every 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | until event or study cut-off date | 
| Response rate |  | tumor assessment every 6 weeks | 
| Safety profile |  | assessment every 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelium, tubulin modulator, combretastatin, cisplatin