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

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism, Cancer

In brief

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.

Key facts

Study ID

NCT00694382

Run by

Sanofi

People needed

3212

Starts

2008-06-01

Expected to finish

2010-11-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site Number 840007 — Casa Grande, Arizona, United States
• Investigational Site Number 840060 — Tucson, Arizona, United States
• Investigational Site Number 840050 — Fountain Valley, California, United States
• Investigational Site Number 840072 — Fullerton, California, United States
• Investigational Site Number 840037 — Indian Wells, California, United States
• Investigational Site Number 840069 — La Verne, California, United States
• Investigational Site Number 840009 — Long Beach, California, United States
• Investigational Site Number 840001 — Oceanside, California, United States
• Investigational Site Number 840011 — Rancho Mirage, California, United States
• Investigational Site Number 840029 — West Covina, California, United States
• Investigational Site Number 840005 — Norwich, Connecticut, United States
• Investigational Site Number 840064 — Torrington, Connecticut, United States
• Investigational Site Number 840038 — Woodbridge, Connecticut, United States
• Investigational Site Number 840052 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840025 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840074 — Clearwater, Florida, United States
• Investigational Site Number 840019 — Jacksonville, Florida, United States
• Investigational Site Number 840051 — Rockledge, Florida, United States
• Investigational Site Number 840073 — Sarasota, Florida, United States
• Investigational Site Number 840070 — Roswell, Georgia, United States
• Investigational Site Number 840016 — Park Ridge, Illinois, United States
• Investigational Site Number 840028 — Quincy, Illinois, United States
• Investigational Site Number 840008 — Skokie, Illinois, United States
• Investigational Site Number 840033 — Goshen, Indiana, United States
• Investigational Site Number 840006 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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