2023-509569-19-00招募中3 期
A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 935
- 试验地点
- 106
- 主要终点
- Time to first event of centrally adjudicated VTE recurrence through 6 months
研究概览
简要总结
The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months post randomization in patients with cancer and recently diagnosed VTE. If non-inferiority is demonstrated, then superiority will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥18 years old or another legal maturity age according to the country of residence
- •Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following: Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or oCurrently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
- •Confirmed symptomatic or incidental proximal lower limb DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic or incidental PE of a segmental, or larger pulmonary artery, and/or a confirmed symptomatic or incidental PE of two or more subsegmental pulmonary arteries. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
- •Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated.
- •Able to provide written informed consent.
排除标准
- •Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE •More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
- •Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
- •Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
- •Life expectancy <3 months at randomization
- •Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation) at the screening visit
- •Hemoglobin less than 8 g/dL at the screening visit
- •Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range at the screening visit in absence of clinical explanation
- •Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
- •Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab (See Section 5.3.6 for highly effective contraceptive measures).
- •Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
- •An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
- •Pregnant or breast-feeding women
- •Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P-gp
- •History of hypersensitivity to any of the study drugs (including apixaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
- •Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study
- •Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic noninterventional or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.
- •Platelet count <50,000/mm3 at the screening visit
- •PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg or shock)
- •Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks preceding screening
- •Brain trauma, or a cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia in the 4 weeks preceding screening
- •Need for aspirin in a dosage of more than 100 mg/per day or any other antiplatelet agent alone or in combination with aspirin
- •Primary brain cancer or untreated intracranial metastases at baseline
- •Acute myeloid or lymphoid leukemia at baseline
结局指标
主要结局
Time to first event of centrally adjudicated VTE recurrence through 6 months
Time to first event of centrally adjudicated VTE recurrence through 6 months
次要结局
未报告次要终点
研究者
Anthos Therapeutics Information Desk
Scientific
Anthos Therapeutics Inc.
研究点 (106)
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