NCT07493304招募中3 期
A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 6
研究概览
简要总结
This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis [DVT]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism [PE]) (Part 2).
The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban).
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
- •In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol
- •Part 1 additional criteria:
- •Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
- •Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
- •Part 2 additional criteria:
- •Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
- •Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE
排除标准
- •Is at high risk of intracranial bleeding in the opinion of the investigator
- •Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
- •Contraindication to anticoagulation in the opinion of the investigator
- •Life expectancy of < 6 months
- •Part 1 participants with cancer and Part 2 additional exclusion criteria:
- •Has acute leukemia or myelodysplastic syndrome
- •Has primary brain tumor
- •Has brain metastases as described in the protocol
- •Part 1 additional exclusion criteria:
- •Has a symptomatic PE
- •Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
- •Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
REGN7508
Experimental
干预措施: REGN7508 (Drug)
Apixaban
Active Comparator
干预措施: Apixaban (Drug)
研究者
研究点 (6)
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