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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 4, 2010
Last updated: December 20, 2011
Last verified: December 2011

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

Condition Intervention Phase
Neoplasms, Malignant
Drug: Ombrabulin (AVE8062)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [14C]-AVE8062
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.
Drug: Ombrabulin (AVE8062)

Pharmaceutical form:concentrate solution

Route of administration: intravenous infusion

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01063946

Sanofi-Aventis Administrative Office
Brussels, Belgium
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01063946     History of Changes
Other Study ID Numbers: BEX6587  2008-007824-24 
Study First Received: February 4, 2010
Last Updated: December 20, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on May 05, 2016