Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Condition(s) studied
Investigational drug(s) / intervention(s)
REGN7508: Administered per the protocol
Apixaban: Administered per the protocol
Study summary
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)
Eligibility
Primary outcome measure(s)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Approximately 6 months
Part 1 - Severity of TEAEs — Approximately 6 months
Part 1 - 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)] — Up to approximately 3.5 years
Part 2 - Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding — Up to approximately 3.5 years
Part 2
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Bioresearch Partner- Hialeah Hospital | Hialeah | Florida | Withdrawn |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| El Paso Medical Research Institute (Medresearch Inc) | El Paso | Texas | Withdrawn |
| Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia | Sofia | Bulgaria | Recruiting |
| Tokai University Hospital | Isehara-Shi | Kanagawa | Recruiting |
| Yamaguchi University Hospital | Ube | Yamaguchi | Recruiting |
| Institute of Oncology Bucharest | Bucharest | Bucharest | Recruiting |
| Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta" | Cluj-Napoca | Cluj | Recruiting |
| Yonsei University Health System, Yongin Severance Hospital | Yongin-si | Gyeonggi-do | Recruiting |
| Inje University, Haeundae Paik Hospital | Busan | South Korea | Recruiting |
| Yonsei University Health System, Severance Hospital | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
On this site
📄 Eliquis (apixaban) drug profile →More Regeneron Pharmaceuticals trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07493304 on ClinicalTrials.gov ↗ ← All trials in South Korea