Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of
ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of
related Dose Limiting Toxicities (DLTs).
Secondary Objectives:
- To assess the overall safety profile of the combination
- To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when
given in combination
- To evaluate preliminary evidence of anti-tumor activity
- To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound)
DCE-US, measuring biomarkers