A multinational, randomized, double blind, placebo-controlled study to evaluate 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. - SAVE-ONCO
- Conditions
- -I82I82
- Registration Number
- PER-087-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• With solid metastatic or locally advanced tumor in the lung, pancreas, stomach, colon / rectum, bladder or ovary;
• That they have planned to start a (new) cycle of chemotherapy with the intention of doing a therapy of at least 3 months;
• Have signed an informed consent.
• Legal limitations due to minority (specific to each country);
• Life expectancy of less than 3 months;
• Degree of performance according to the ECOG (Oncologico Cooperativo del Este Group) of o 4 (refer to Appendix A);
• Clearance of creatinine <30 mL / min according to the Cockroft and Gault formula (21);
• Some serious surgery (ie, open surgery of more than 45 minutes duration from opening to closing) performed within the last 6 weeks or planned during the study treatment period.
• Significant, active or recent bleeding (<3 months), including gastrointestinal hemorrhage or peptic ulcer;
• History of bleeding disorder (repeated episodes of congenital bleeding, acquired or unexplained);
• Uncontrolled hypertension (systolic blood pressure> 180 mm Hg or diastolic blood pressure> 110 mm Hg);
• Hemorrhagic stroke or brain, spinal or recent ophthalmic surgery (performed in the last 3 months);
• Known cerebral hemorrhagic lesion.
• Primary or metastatic humor that, according to the researcher, has a high risk of causing a hemorrhage;
• Known structural damage or other pathological process involving the central nervous system (brain metastasis, vascular malformation, etc.);
• Thrombocytopenia (platelet count <100 x 10 9/1);
• Activated partial thromboplastin time (aPTT)> 1.5 ULN or International Normalized Radio (RIN)> 1.5;
• Any treatment with other antithrombotic agents within 2 weeks prior to randomization or planned during the course of the study
• The subject that requires systematic prevention of venous thrombosis with anticoagulant or a curative anticoagulant or thrombolytic treatment;
• Obstruction of the pelvic vein or superior vena cava syndrome;
• Subject who probably will not comply with the protocol, for example, who has a non-cooperative attitude, who can not return for follow-up visits, who is not able to receive daily injections (self-injected or applied by a relative or health professional) ) and probably will not complete the study;
• Treatment with a research product or research device during the last 30 days or 5 half lives (if relevant) prior to the random distribution;
• Any previous exposure to AVE5026 (for example, participation in a previous clinical study with AVE5026);
• History of thrombocytopenia induced by heparin;
• Known hypersensitivity to unfractionated heparin or low molecular weight heparin;
• Pregnant or lactating woman, or woman with unprotected reproductive potential with a highly effective contraceptive method of birth control, as defined in the contraceptive section of the Informed Consent Form and / or in an appendix of a local protocol for the duration of the study and / or that is not willing to or can not perform a pregnancy test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Appearance of manifestations of the following DVT pictures of the lower limbs, DVT of the upper limbs, Pulmonary embolism<br>Measure:Period of time until the first manifestation of some component of the evaluation parameter composed of the documented results of clinical outcomes, confirmed by the CIAC, that occurs from the random distribution up to 3 days after the last administration of the study treatment<br>Timepoints:from the random distribution up to 3 days after the last administration of the study treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Events: - All symptomatic DVT of the lower limbs -All symptomatic DVT of the upper limbs (including a thrombosis related to the CVC) -All EP<br>Measure:Period of time until the first manifestation of the events, from the random distribution to 3 calendar days, after the last administration of the study treatment<br>Timepoints:up to 3 calendar days, after the last study treatment administration<br>;<br>Outcome name:Record of the moment in which the anticoagulant or anti-thrombotic curative treatment is initiated by the researcher.<br>Measure:Start of curative anticoagulant or thrombolytic treatment by the Investigator after the local evaluation of the TEV<br>Timepoints:after the local evaluation of the TEV<br>