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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.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01063946
First received: February 4, 2010
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 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 ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Sanofi-Aventis Administrative Office
Brussels, Belgium
Sponsors and Collaborators
Sanofi
Investigators
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 ( EudraCT Number )
Study First Received: February 4, 2010
Last Updated: December 20, 2011

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2017