A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives:

• To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of [14C]-AVE8062 to humans

• To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure

• To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites

Secondary Objective:

• To assess the safety profile of the drug

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

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria:

• Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists.

• Age = or > 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Adequate hematological, hepatic and renal functions

Exclusion criteria:

• Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study

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