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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel

Criteria

Inclusion criteria:

• Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer.

• ECOG performance status of 0 to 1.

Exclusion criteria:

• Concurrent treatment with any other anticancer therapy.

• Patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy.

• Brain metastases and carcinomatous leptomeningitis.

• Prior intensive chemotherapy with autologous stem cell rescue.

• Patients who received a high cumulative dose of anthracycline (i.e doxorubicin > 400mg/m2 or epirubicin >750 mg/m2).

• Impaired cardiovascular function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.