NCT07493304Toboroz3. fázis
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 21.
Rövid összefoglaló (regiszter, angolul)
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)
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1600 (tervezett)
- Első benyújtás
- 2026. márc. 5.
- Kezdés
- 2026. aug. 26.
- Elsődleges befejezés
- 2031. júl. 18.
- Fő szponzor
- Regeneron Pharmaceuticals
- NCT-szám
- NCT07493304
- EU CT-szám
- 2024-519299-16-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1600
- 2026. aug. 26. és az elsődleges befejezés (2031. júl. 18.) között
- 13 helyszín, 5 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 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)
- 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
Egyéb
- Contraindication to anticoagulation in the opinion of the investigator
- Life expectancy of < 6 months
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (13)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia | Sofia | Bulgária | Toboroz |
| Tokai University Hospital | Isehara-Shi | Japán | Toboroz |
| Yamaguchi University Hospital | Ube | Japán | Toboroz |
| Inje University Haeundae Paik Hospital | Busan | Dél-Korea | Toboroz |
| Seoul National University Hospital | Seoul | Dél-Korea | Toboroz |
| Yonsei University Health System, Severance Hospital | Seoul | Dél-Korea | Toboroz |
| Samsung Medical Center | Seoul | Dél-Korea | Toboroz |
| Yonsei University Health System, Yongin Severance Hospital | Yongin-si | Dél-Korea | Toboroz |
| Institute of Oncology Bucharest | Bucharest | Románia | Toboroz |
| Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta" | Cluj-Napoca | Románia | Toboroz |
| El Paso Medical Research Institute (Medresearch Inc) | El Paso | Egyesült Államok | Visszavonva |
| Bioresearch Partner- Hialeah Hospital | Hialeah | Egyesült Államok | Visszavonva |
| Memorial Sloan-Kettering Cancer Center | New York | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.