Clinical Trials Detalhe
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
General Information
Gender
ALL
Age
N/A
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
Investigational Site Number 620003 (Aveiro, Portugal)
Investigational Site Number 620009 (Guimarães, Portugal)
Investigational Site Number 620004 (Lisbon, Portugal)
Investigational Site Number 620008 (Matosinhos Municipality, Portugal)
Investigational Site Number 620007 (Porto, Portugal)
Investigational Site Number 620002 (Setúbal, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00694382Summary
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.
Conditions
Venous Thromboembolism
Cancer
Eligibility
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