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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519299-16-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 | Experimental |
| |
| Apixaban | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
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:
Part 2 additional criteria:
Key Exclusion Criteria:
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:
Part 1 additional exclusion criteria:
Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
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 |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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| Apixaban | Drug | Administered per the protocol |
|
| 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 |
| El Paso Medical Research Institute (Medresearch Inc) |
| Recruiting |
| El Paso |
| Texas |
| 79902 |
| United States |
| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |