None listed
Conditions
Interventions
Group 1 Type of group
20 mg of AVE5026 subcutaneous daily for 6 months
Group name:Group 2 Type of group
Placebo subcutaneous daily for 6 months
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Appearance of manifestations of the following DVT pictures of the lower limbs, DVT of the upper limbs, Pulmonary embolism 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 Timepoints:from the random distribution up to 3 days after the last administration of the study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 Timepoints:up to 3 calendar days, after the last study treatment administration ; Outcome name:Record of the moment in which the anticoagulant or anti-thrombotic curative treatment is initiated by the researcher. Measure:Start of curative anticoagulant or thrombolytic treatment by the Investigator after the local evaluation of the TEV Timepoints:after the local evaluation of the TEV | — |
Countries
Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latovia, Lithuania, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kindgdom
Contacts
Public ContactLourdes Teresa Paz
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed