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De klinische studie NCT07493304 (ROXI-CAT-II) voor Veneuze trombo-embolie (VTE) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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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 3 1.600 Preventie
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De klinische studie NCT07493304 (ROXI-CAT-II) onderzoekt behandeling bij Veneuze trombo-embolie (VTE). Deze Fase 3 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 1.600 deelnemers begint op 7 april 2026. De studie wordt geleid door Regeneron Pharmaceuticals en de voltooiing is gepland op 8 juli 2031. Laatste update op ClinicalTrials.gov: 25 maart 2026.
Beknopte samenvatting
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...Toon meer
Officiële titel
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)
Aandoeningen
Veneuze trombo-embolie (VTE)Andere studie-ID's
- ROXI-CAT-II
- R7508-CAT-2396
- 2024-519299-16-00 (EU-studienummer (CTIS))
NCT-ID
Startdatum (Werkelijk)
2026-04-07
Laatste update geplaatst
2026-03-25
Verwachte einddatum
2031-07-08
Inschrijving (Geschat)
1.600
Studietype
Interventioneel
FASE
Fase 3
Status
Nog niet rekruterend
Trefwoorden
Cancer-Associated Thrombosis (CAT)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelREGN7508 | REGN7508 Administered per the protocol |
Actieve comparatorApixaban | Apixaban Administered per the protocol |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
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 actieve klinische studies om te verkennenCentraal Contactpersoon
Contact: Clinical Trials Administrator, 844-734-6643, [email protected]
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