Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
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.