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

Neoplasms, Malignant Clinical Trial

Official title: A Phase I, Open Label Study Investigating the Disposition of 25 mg/m² [14C]-AVE8062 (1.85 MBq, 50 µCi) Administered at Cycle 1 as a 30-minute Intravenous Infusion to Patients With Advanced Solid Tumors

Status Completed

Clinical Trial 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

Clinical Trial Description

The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment. ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Malignant

• NCT number: NCT01063946
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Completion date: September 2011