Advanced Neoplastic Disease Clinical Trial
Official title:
An Open Label, Dose Escalation, Safety and Pharmacokinetic Phase 1 Study With AVE8062 Administered as a 30 Minutes Intravenous Infusion Followed by Docetaxel Administered as an 1 Hour Intravenous Infusion 24 Hours-Apart Every 3 Weeks in Patients With Advanced Solid Tumors
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.
The duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. Each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment