drugset / Trial / NCT01063946

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

NCT01063946 ↗

Phase 1 Completed 3 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2010-01
Primary completion
2011-03
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ombrabulin Other / unclassified 25 mg/m2 Intravenous

Indications