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Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Supportive care | Active | 18 and over | EFC6521
EudraCT 2007-007943-29, NCT00694382 |
Trial Description
Summary The primary objective is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy. The secondary objectives are to evaluate the safety of AVE5026, to document AVE5026 exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population. Further Study Information The study treatment duration is variable depending on the duration of chemotherapy. Eligibility Criteria Inclusion Criteria: - Cancer patients 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: - Subject requiring systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic
- Patients at high risk of bleeding
- Severe renal impairment (estimated creatinine clearance < 30 mL/min)
- ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4
- Known hypersensitivity to UFH or LMWH
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial Contact Information
Trial Lead Organizations/Sponsors Sanofi-Aventis - US - Bridgewater | Alexander Turpie, MD |  | Study Chair |
| Giancarlo Agnelli, MD | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| New Jersey |
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Bridgewater |
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| | | | | | | | Sanofi-Aventis - US - Bridgewater |
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| Australia |
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| New South Wales |
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Macquarie Park |
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| | | | | Sanofi-Aventis Australia |
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| Austria |
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Wien |
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| | | | Sanofi-Aventis Administrative Office |
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| Belgium |
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Diegem |
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| | | | Sanofi-Aventis Admnistrative Office |
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| Brazil |
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Sao Paulo |
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| | | | Sanofi-Aventis Brazil |
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| Canada |
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Laval |
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| | | | Sanofi-Aventis Canada |
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| Chile |
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Santiago |
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| | | | Sanofi-Aventis Chile |
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| Colombia |
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Santafe de Bogota |
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| | | | Sanofi-Aventis Colombia |
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| Croatia |
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Zagreb |
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| | | | Sanofi-Aventis Administrative Office |
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| Czech Republic |
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Praha |
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| | | | Sanofi-Aventis Czech Republic |
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| Denmark |
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Horsholm |
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| | | | Sanofi-Aventis Denmark |
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| Estonia |
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Tallinn |
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| | | | Sanofi-Aventis Estonia |
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| Finland |
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Helsinki |
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| | | | Sanofi-Aventis Finland |
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| France |
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Paris |
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| | | | Sanofi-Aventis France |
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| Germany |
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Berlin |
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| | | | Sanofi-Aventis Germany |
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| Hungary |
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Budapest |
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| | | | Sanofi-Aventis Hungary |
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| India |
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Mumbai |
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| | | | Sanofi-Aventis India |
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| Ireland |
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Dublin |
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| | | | Sanofi-Aventis Administrative Office |
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| Israel |
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Natanya |
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| | | | Sanofi-Aventis Israel |
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| Italy |
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Milano |
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| | | | Sanofi-Aventis Italy |
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| Latvia |
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Riga |
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| | | | Sanofi-Aventis Administrative Office |
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| Lithuania |
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Vilnius |
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| | | | Sanofi-Aventis Administrative Office |
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| Malaysia |
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Kuala Lumpur |
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| | | | Sanofi-Aventis Administraive Office |
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| Mexico |
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Mexico |
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| | | | Sanofi-Aventis Mexico |
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| Netherlands |
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Gouda |
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| | | | Sanofi-Aventis Netherlands |
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| Norway |
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Lysaker |
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| | | | Sanofi-Aventis Norway |
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| Peru |
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Lima |
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| | | | Sanofi-Aventis Peru |
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| Poland |
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Warzsawa |
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| | | | Sanofi-Aventis Administrative Office |
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| Portugal |
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Porto Salvo |
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| | | | Sanofi-Aventis Portugal |
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| Republic of Bulgaria |
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Sofia |
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| | | | Sanofi-Aventis Bulgaria |
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| Republic of Korea |
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Seoul |
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| | | | Sanofi-Aventis South Korea |
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| Romania |
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Bucuresti |
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| | | | Sanofi-Aventis Romania Limited |
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| Russia |
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Moscow |
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| | | | Sanofi-Aventis Russia |
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| Serbia |
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Belgrade |
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| | | | Sanofi-Aventis Administrative Office |
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| Slovakia |
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Brastislava |
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| | | | Sanofi-Aventis Administrative Office |
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| Slovenia |
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Ljubljana |
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| | | | Sanofi-Aventis Administrative Office |
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| Spain |
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Barcelona |
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| | | | Sanofi-Aventis Spain - Barcelona |
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| Sweden |
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Bromma |
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| | | | Sanofi-Aventis Sweden |
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| Ukraine |
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Kiev |
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| | | | Sanofi-Aventis Ukraine |
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| United Kingdom |
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Guildford Surrey |
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| | | | Sanofi-Aventis United Kingdom |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00694382
Information obtained from ClinicalTrials.gov on May 06, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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