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

Conditions

• Neoplasms, Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ombrabulin (AVE8062) — DRUG
  Pharmaceutical form:Solution for infusion Route of administration: Intravenous
• bevacizumab — DRUG
  Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Study Details

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

Key Dates

First listed

Sep 2, 2010

Start date

Sep 30, 2010

Status verified

Dec 2014

Primary completion

Oct 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

39 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: AVE8062/ bevacizumab
  The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD [ Time Frame: 3 weeks ]