Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors

Summary

Primary Objective: * To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with cisplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To assess the overall safety profile of the combination therapy. * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, and cisplatin in combination. * To evaluate anti-tumor activity of the combination therapy.

Timeline

Start

2010-03

Primary completion

2011-05

Completion

2011-05

Drugs

Indications