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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063946
• Other study ID #: BEX6587
• Secondary ID: 2008-007824-24
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2010
• Last updated: December 20, 2011
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists.

• Age = or > 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Adequate hematological, hepatic and renal functions

Exclusion criteria:

• Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Intervention

Drug:
• Ombrabulin (AVE8062)
Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of radioactive dose excreted in urine, feces and expired air		3 weeks (end of cycle 1) or 30 days after the first dose	No
Primary	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	No
Secondary	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	Yes