Status:
COMPLETED
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
Lead Sponsor:
Sanofi
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically proven soft tissue sarcoma
- Unresectable locoregional recurrent or metastatic soft tissue sarcoma
- Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy
- Exclusion criteria:
- Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
- Brain metastases and carcinomatous leptomeningitis
- Uncontrolled hypertension
- Known platinum hypersensitivity
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00699517
Start Date
June 1 2008
End Date
April 1 2013
Last Update
December 21 2015
Active Locations (45)
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1
Investigational Site Number 840004
Santa Monica, California, United States, 90403
2
Investigational Site Number 840003
Orlando, Florida, United States, 32806
3
Investigational Site Number 840005
Maywood, Illinois, United States, 60153
4
Investigational Site Number 840002
Newark, New Jersey, United States, 07103