Neoplasms, Malignant Clinical Trial
Official title:
An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.
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
The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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