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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519298-21-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death | 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 | Through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death | Through 6 months | |
| Time-to-first event of symptomatic VTE | Through 6 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioresearch Partner- Hialeah Hospital | Recruiting | Hialeah | Florida | 33013 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D009369 | Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Drug | Administered per the protocol |
|
| Time-to-first event of symptomatic DVT | Through 6 months |
| Time-to-first event of symptomatic non-fatal PE | Through 6 months |
| Time-to-first event of thromboembolism-related death | Through 6 months |
| Time-to-first event of incidental VTE | Through 6 months |
| Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT | Through 6 months |
| Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery) | Through 6 months |
| Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound) | Through 6 months |
| Time-to-first event of ATE | Through 6 months |
| Time-to-first event of ATE-related death | Through 6 months |
| Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death | Through 6 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to day 245 |
| Severity of TEAEs | Up to day 245 |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Up to day 245 |
| Magnitude of ADA to REGN7508 | Up to day 245 |
| Helios Clinical Research |
| Recruiting |
| North Miami Beach |
| Florida |
| 33169 |
| United States |
| El Paso Medical Research Institute (Medresearch Inc) | Recruiting | El Paso | Texas | 79902 | United States |
| LTD High Technology Hospital Medcenter | Recruiting | Batumi | Adjara | 6000 | Georgia |
| Krystyna Kiel Oncology Center | Recruiting | Kutaisi | Imereti | 4600 | Georgia |
| American Hospital Tbilisi | Recruiting | Tbilisi | 0102 | Georgia |
| Llc Todua Clinic | Recruiting | Tbilisi | 0112 | Georgia |
| Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic | Recruiting | Tbilisi | 0144 | Georgia |
| Institute of Clinical Oncology | Recruiting | Tbilisi | 0159 | Georgia |
| JSC Evex Hospitals - Caraps Medline | Recruiting | Tbilisi | 0179 | Georgia |
| LTD Cancer Research Centre | Recruiting | Tbilisi | 0179 | Georgia |
| Caucasus Medical Centre | Recruiting | Tbilisi | 0186 | Georgia |
| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |