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

Phase 1

Completed

• Conditions: Neoplasms, Malignant
• Interventions: Drug: Ombrabulin (AVE8062)

• Registration Number: NCT01063946
• Lead Sponsor: Sanofi

Brief 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

Detailed 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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2011-03
• Study Completion: 2011-09
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-AVE8062	Ombrabulin (AVE8062)	Single, 30 minute, intravenous infusion of 25 mg/m² of \[14C\]-AVE8062 containing 1.85 MBq (50µCi) at the first cycle, followed by subsequent administrations with non-radiolabelled AVE8062 in combination with cisplatin every 3 weeks, according to the investigator's judgment.

Primary Outcome Measures

Name	Time	Method
Percentage of radioactive dose excreted in urine, feces and expired air	3 weeks (end of cycle 1) or 30 days after the first dose
Concentration-time profiles and pharmacokinetic (PK) parameters of total radioactivity in whole blood and plasma; blood over plasma concentration ratios; Concentration-time profile and PK parameters of AVE8062 and RPR258063 in plasma	3 weeks (end of cycle 1) or 30 days after the first dose

Secondary Outcome Measures

Name	Time	Method
Safety assessment based on Adverse events reporting, laboratory tests according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) v3.0 grade scaling	3 weeks (end of cycle 1) or 30 days after the first dose

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇪 Brussels, Belgium