Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Heparin, Low-Molecular-Weight; Semuloparin

Criteria

Inclusion Criteria:

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 Criteria:

• 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