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

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Trial Identification

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

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

Study ID: NCT01063946

Conditions

Neoplasms, Malignant

Interventions

Ombrabulin (AVE8062)

Study Description

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.