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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

NCT01063946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2011-12-21

No results posted yet for this study

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

Conditions

  • Neoplasms, Malignant

Interventions

DRUG

Ombrabulin (AVE8062)

Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-03-31
Completion
2011-09-30

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063946 on ClinicalTrials.gov