A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2008 |
| End Date: | April 2013 |
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.
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.
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.
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.
We found this trial at
7
sites
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