A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to determine the maximum tolerated dose (MTD) based on
the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of
ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients
with advanced solid tumors.
Secondary Objectives:
- To assess the overall safety profiles of the combination therapy
- To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR
258063, paclitaxel, and carboplatin when used in combination
- To document the objective tumor response