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

Sanofi3 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms, Malignant

Interventions

Ombrabulin (AVE8062)DRUG

Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Brussels, Belgium

Outcomes

Primary Outcomes

Percentage of radioactive dose excreted in urine, feces and expired air

Time frame: 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

Time frame: 3 weeks (end of cycle 1) or 30 days after the first dose

Secondary Outcomes

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

Time frame: 3 weeks (end of cycle 1) or 30 days after the first dose

Data from ClinicalTrials.gov

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