Status:
COMPLETED
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patie...
Detailed Description
Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). The study period per participant was variable depending on the duration of chemotherapy. It inc...
Eligibility Criteria
Inclusion
- Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy
Exclusion
- Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
- High risk of bleeding;
- Severe renal impairment (estimated creatinine clearance \<30 mL/min);
- ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4;
- Major surgery within 4 weeks before randomization;
- Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\].
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3212 Patients enrolled
Trial Details
Trial ID
NCT00694382
Start Date
June 1 2008
End Date
November 1 2010
Last Update
January 23 2013
Active Locations (411)
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1
Investigational Site Number 840006
Birmingham, Alabama, United States, 35211
2
Investigational Site Number 840007
Casa Grande, Arizona, United States, 85222
3
Investigational Site Number 840060
Tucson, Arizona, United States, 85704
4
Investigational Site Number 840050
Fountain Valley, California, United States, 92708