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El ensayo clínico NCT07493304 (ROXI-CAT-II) para Tromboembolismo venoso (TEV) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Regeneron PharmaceuticalsTreatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers (ROXI-CAT-II) Fase III 1600 Prevención
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07493304 (ROXI-CAT-II) está diseñado para estudiar el tratamiento de Tromboembolismo venoso (TEV). Este es un estudio intervencionista de Fase III. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 7 de abril de 2026 hasta completar 1600 participantes. Dirigido por Regeneron Pharmaceuticals, se espera que finalice el 8 de julio de 2031. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
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 Pulmo...Mostrar más
Título oficial
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)
Condiciones médicas
Tromboembolismo venoso (TEV)Otros ID del estudio
- ROXI-CAT-II
- R7508-CAT-2396
- 2024-519299-16-00 (Número CTIS (UE))
Número del NCT
Inicio del estudio (real)
2026-04-07
Última actualización
2026-03-25
Fecha de finalización (estimada)
2031-07-08
Inscripción (prevista)
1600
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Aún no recluta
Palabras clave
Cancer-Associated Thrombosis (CAT)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalREGN7508 | REGN7508 Administered per the protocol |
Comparador activoApixaban | Apixaban Administered per the protocol |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Part 1 | Approximately 6 months |
Severity of TEAEs | Part 1 | Approximately 6 months |
Time-to-first event of centrally adjudicated recurrent VTE [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery] )or VTE-related death)] | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding | Part 2 | Up to approximately 3.5 years |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Percent inhibition of Factor XI functional Coagulant activity (FXI:C) | Part 1 | Approximately 3 months |
Fold change from baseline in activated Partial Thromboplastin Time (aPTT) | Part 1 | Approximately 3 months |
Functional REGN7508 concentration | Part 1 | Approximately 3 months |
Factor XI (FXI) concentration | Part 1 | Approximately 3 months |
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Part 1 and Part 2 | Up to approximately 3.5 years |
Magnitude of ADA to REGN7508 | Part 1 and Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal]) | Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery]) | Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of VTE-related death | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE) | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated recurrent VTE and bleeding events [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic) or VTE-related death) or bleeding (ISTH-defined major bleeding or CRNM bleeding)] | Part 2 | Up to approximately 3.5 years |
Occurrence of TEAEs | Part 2 | Up to approximately 3.5 years |
Severity of TEAEs | Part 2 | Up to 3.5 approximately years |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
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
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
Regeneron Pharmaceuticals214 estudios activos para explorarContactos centrales del estudio
Contacto: Clinical Trials Administrator, 844-734-6643, [email protected]
Sitio no especificado.