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OpenTrials
Completed

NCT Number: NCT01063946

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

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

Completed

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Key information

Conditions

Neoplasms, Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ombrabulin (AVE8062)

Drug

Pharmaceutical form:concentrate solution

Route of administration: intravenous infusion

Primary outcomes

  1. 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

  2. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2010
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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