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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Malignant

Treatments: Drug: Ombrabulin (AVE8062)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063946

2008-007824-24 (EudraCT Number)

BEX6587

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

[14C]-AVE8062

Experimental group

Description:

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.

Treatment:

Drug: Ombrabulin (AVE8062)