Thromboembolism
A Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evalate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and who are Undergoing Chemotherapy
Eligibility Criteria (per Protocol dated 02/15/08):
- Cancer patients with locally advanced solid tumor of the lung(s), pancreas, stomach, colon/rectum, bladder, or ovary.
- Subject not eligible if ECOG Performance Status is 3 or 4.
- Subject not eligible if there has been any major surgery (i.e., open surgery lasting more than 45 minutes from opening to closure) within the last 6 weeks or planned during the study treatment period.
- Subject not eligible if there have been any treatment(s) with other anti-thrombotic agents within 2 weeks prior to randomization or planned during the course of the study.
- Subject not eligible if he/she requires a systematic venous thromboprophylaxis with anticoagulant or a curative anti-coagulant or thrombolytic treatment.
- Subject not eligible if he/she has pelvic venous obstruction or superior vena cava syndrome.
- Subject not eligible if there has been treatment with any investigational product or investigational device in the last 30 days or 5 half lives (if relevant) prior to randomization.
- Subject not eligible if there is a history of heparin-induced thrombocytopenia.
- Subject not eligible if there is known hypersensitivity to UFH or LMWH.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.