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

2014-07-24 14:10:04 | BioPortfolio

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

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

Conditions

Neoplasms, Malignant

Intervention

Ombrabulin (AVE8062)

Location

Sanofi-Aventis Administrative Office
Brussels
Belgium

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:04-0400

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