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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Investigational Site Number 250001
Villejuif, France
Investigational Site Number 380002
Milan, Italy
Investigational Site Number 380001
Milan, Italy
Investigational Site Number 826001
Sutton, United Kingdom
Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD
Time frame: 3 weeks
Overall safety profile of the combination
Time frame: up to a maximum follow-up of 1 year
Pharmacokinetic parameters of ombrabulin
Time frame: 6 weeks
Pharmacokinetic parameters of bevacizumab
Time frame: 6 weeks
Preliminary evidence of antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to a maximum follow-up of 1 year
Pharmacodynamic effect (biomarkers)
Time frame: cycle 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.