REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)

Обзор

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants. The aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT. 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 study drug less effective or could lead to side effects)

Вмешательства

• Препарат REGN7508
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol

Первичные конечные точки

• Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death [Срок оценки: Through 6 months]
• Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding [Срок оценки: Through 6 months]

Вторичные конечные точки (12)

• Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death [Срок оценки: Through 6 months]
• Time-to-first event of symptomatic VTE [Срок оценки: Through 6 months]
• Time-to-first event of symptomatic DVT [Срок оценки: Through 6 months]
• Time-to-first event of symptomatic non-fatal PE [Срок оценки: Through 6 months]
• Time-to-first event of thromboembolism-related death [Срок оценки: Through 6 months]
• Time-to-first event of incidental VTE [Срок оценки: Through 6 months]
• Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT [Срок оценки: Through 6 months]
• Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery) [Срок оценки: Through 6 months]
• Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound) [Срок оценки: Through 6 months]
• Time-to-first event of ATE [Срок оценки: Through 6 months]
• Time-to-first event of ATE-related death [Срок оценки: Through 6 months]
• Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death [Срок оценки: Through 6 months]

Критерии участия

Критерии включения

• Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
• Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention

Критерии исключения

• Has 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)
• Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
• Has a primary brain tumor or brain metastases as described in the protocol
• Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
• Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Грузия · 9 центров

• LTD High Technology Hospital Medcenter — Batumi
• Krystyna Kiel Oncology Center — Kutaisi
• American Hospital Tbilisi — Tbilisi
• Llc Todua Clinic — Tbilisi
• Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi
• Institute of Clinical Oncology — Tbilisi
• JSC Evex Hospitals - Caraps Medline — Tbilisi
• LTD Cancer Research Centre — Tbilisi
• … и ещё 1 центр

США · 3 центра

• Bioresearch Partner- Hialeah Hospital — Hialeah
• Helios Clinical Research — North Miami Beach
• El Paso Medical Research Institute (Medresearch Inc) — El Paso

Япония · 1 центр

• Yamaguchi University Hospital — Ube

Идентификаторы

NCT: NCT07410117 · R7508-CAT-2392 · 2024-519298-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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