EUCTR2007-007943-29-SE进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Cancer patients:
- •1. With metastatic or locally advanced solid tumor of the lung, pancreas, stomach, colon/rectum, bladder or ovary,
- •2. Planned to start a (new) course of chemotherapy with a minimum intent of 3 months therapy,
- •3. With signed informed consent.
- •Chemotherapy is defined as any conventional cytotoxic treatment.
- •Biological agents used alone are not considered as chemotherapy but could be associated with cytotoxic agents.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria related to study methodology:
- •1. Legal lower age limitations (country specific)
- •2. Life expectancy less than 3 months
- •3. ECOG (Eastern Cooperative Oncology Group) Performance status of 3 or 4
- •4. Calculated creatinine clearance <30 mL/min according to Cockroft and Gault formula
- •5. Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within the last 4 weeks or planned during the study treatment period
- •6. Contra-indications to anticoagulation:
- •- Active or recent (<3 months) significant bleeding, including gastrointestinal bleeding or peptic ulcer.
- •- History of bleeding disorder (congenital, acquired or unexplained repeated bleeding episodes)
- •- Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
- •- Hemorrhagic stroke or recent (in the last 3 months) brain, spinal or ophthalmic surgery
- •- Known cerebral hemorrhagic lesion
- •- Primary or metastatic tumor which is at high bleeding-risk according to investigator’s judgment
- •- Known structural damage or other pathologic process involving the central nervous system (brain metastases, vascular malformation…)
- •- Thrombocytopenia (platelet count < 100 x 10 9 /l)
- •- Activated partial thromboplastin time (aPTT) > 1.5 ULN or International Normalized ratio (INR) >1.5.
- •7. Any treatment with other anti-thrombotic agents within 2 weeks prior to randomization or planned during the study treatment period such as:
- •- Parenteral anticoagulants (UFH, LMWH: enoxaparin, dalteparin, nadroparin..., or other
- •agents such as fondaparinux, bivalirudin, hirudin)
- •- Oral anticoagulants (Vitamin K antagonists)
- •- Anti-GPIIb/IIIa: eptifibatide, tirofiban, abciximab
- •- Thrombolytic agents
- •Note: Chronic treatment with anti-platelet agents such as low dose of aspirin (up to 325 mg/day) or clopidogrel or ticlopidine in patients with coronary artery disease is allowed
- •- To maintain patency of central venous catheter, saline flushing solutions are highly recommended. However, if it is local practice, flushing solutions with small amounts of heparin (max 500 units) are allowed.
- •- Should any occlusion of the CVC occur, it is advised an attempt to restore the CVC patency by infusion of urokinase 5000-10000 units (could be repeated up to a dose of 50 000 units) or alteplase 2 mg.
- •8. Subject who requires a systematic venous thromboprophylaxis with anticoagulant or a curative anti-coagulant or thrombolytic treatment
- •9. Pelvic venous obstruction or superior vena cava syndrome
- •10. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, inability to receive daily injection (self-injection or by relative of patient or by Health care professional) and unlikelihood of completing the study
- •11. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (whichever is longer, if relevant) prior to randomization
- •12. Any previous exposure to AVE5026 (e.g.: participation in any previous AVE5026 clinical trial)
- •Note: A patient could not be randomized in the study more than once
- •Exclusion criteria related to AVE5026:
- •13. History of heparin-induced thrombocytopenia
- •14. Known hypersensitivity to UFH or LMWH
- •15. Pregnant or nursing woman or women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and/or in a local protocol addendum for t
研究者
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