Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors

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

Timeline

Start

2010-09

Primary completion

2014-10

Completion

2014-10

Drugs

Indications