Clinical Research Details
Title:
A Multinational, Randomized, Double-Blind Placebo Controlled Study of AVE8062 Administered Every 3 Weeks, in Patients with Advanced-Stage Soft Tissue Sarcoma Treated with Cisplatin After Failure of Anthracycline and Ifosfamide Chemotherapies.
Purpose:
To compare the progression-free survival, overall survival and the objective response rate in the two treatment arms. To assess the safety profile of AVE8062 (in combination with cisplatin). To assess the pharmacokinetics of AVE8062 and its main metabolite RPR258063, using a population approach, in all patients enrolled in selected centers. To assess genotypes of drug metabolizing enzymes in all enrolled patients in blood sampling collected before the first study drug infusion.
Study Number:
201046
Number of Patients:
300
Elgibility:
The patient must have histologically proven STS at the first diagnosis, which is unresectable locoregional recurrent or metastatic soft tissue sarcoma. The patient must have had previous anthracycline-based regimen and ifosfamide therapy, which failed. The disease must have progressed within 1 month before study randomization.
Treatment:
The patient will receive either AVE8062 or placebo over 30 minutes intravenously through his/her vein, which will be followed by cisplatin over 2-3 hours intravenously through his/her vein every 3 weeks.
Principal Investigator:
Enrollment Phone:
(708) 327-3180