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
- The subjects who will participate to this clinical trial are cancer patients (i.e. patients with metastatic or locally advanced tumor of the lung, pancreas, stomach, colon/ rectum, bladder or ovary) at high risk for VTE and who are undergoing chemotherapy.
- Registration Number
- EUCTR2007-007943-29-AT
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3200
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.
Note:
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
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 an 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method