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Clinical Trials/NCT00699517
NCT00699517
Completed
Phase 3

A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

Sanofi45 sites in 10 countries355 target enrollmentJune 2008
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ConditionsSarcoma
InterventionsOMBRABULIN (AVE8062)Placebo
DrugsOMBRABULIN (AVE8062)Placebo

Overview

Phase
Phase 3
Intervention
OMBRABULIN (AVE8062)
Conditions
Sarcoma
Sponsor
Sanofi
Enrollment
355
Locations
45
Primary Endpoint
Progression free survival
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

  • To compare the overall survival in the 2 treatment arms
  • To compare the objective response rate in the 2 treatment arms
  • To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
  • To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
Registry
clinicaltrials.gov
Start Date
June 2008
End Date
April 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sanofi
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Intervention: OMBRABULIN (AVE8062)

2

Intervention: Placebo

Outcomes

Primary Outcomes

Progression free survival

Time Frame: until event or study cut-off date (Tumor assessment every 6 weeks)

Secondary Outcomes

  • Overall survival(until event or study cut-off date)
  • Response rate(tumor assessment every 6 weeks)
  • Safety profile(assessment every 3 weeks)

Study Sites (45)

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