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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 3,212
- 试验地点
- 411
- 主要终点
- Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
研究概览
简要总结
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.
详细描述
Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).
The study period per participant was variable depending on the duration of chemotherapy. It included:
- a screening period up to 3 weeks,
- a double-blind treatment period,
- a follow-up period of 1 month.
Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Semuloparin
Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
干预措施: Semuloparin sodium (Drug)
Placebo
Placebo (for semuloparin) once daily until change in chemotherapy regimen
干预措施: Placebo (for semuloparin) (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
时间窗: From randomization up to 3 days after last study drug injection
VTE included any symptomatic Deep Vein Thrombosis \[DVT\] of lower or upper limbs and any non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
时间窗: From randomization up to 3 days after last study drug injection
Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
次要结局
- Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment(From randomization up to 3 days after last study drug injection)
- Percentage of Participants Who Experienced Clinically Relevant Bleedings(From first study drug injection up to 3 days after last study drug injection)
- Overall survival [OS](From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first)