Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the
maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered
sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.
Secondary Objectives:
- To define the overall safety profile of the combination.
- To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when
administered in combination.
- To evaluate anti-tumor activity of the combination.
- To evaluate potential predictive biomarkers.
The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The
objective to analyse a set of biological biomarkers in order to identify a potential
predictive signature of efficacy for AVE8062 in combination with docetaxel.