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.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma
Both
Sarcoma
Trial Information
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
until event or study cut-off date (Tumor assessment every 6 weeks)
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC10145
NCT ID:
NCT00699517
Start Date:
June 2008
Completion Date:
April 2013
Related Keywords:
- Sarcoma
- tubulin modulator
- endothelium
- combretastatin
- cisplatin
- Sarcoma
Name | Location |
|---|---|
| Investigational Site Number 840004 | Santa Monica, California 90403 |
| Investigational Site Number 840003 | Orlando, Florida 32806 |
| Investigational Site Number 840005 | Maywood, Illinois 60153 |
| Investigational Site Number 840002 | Newark, New Jersey 07103 |
| Investigational Site Number 840007 | Philadelphia, Pennsylvania 19107 |
| Investigational Site Number 840001 | San Antonio, Texas 78229 |
