Venous Thromboembolism (VTE)
Conditions
Keywords
Cancer-Associated Thrombosis (CAT), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer
Brief 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)
Interventions
DRUGREGN7508
Administered per the protocol
DRUGApixaban
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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 2. 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 3. Part 1 additional criteria: 1. 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) 2. 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 4. Part 2 additional criteria: 1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol 2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE Key
Exclusion criteria
1. Is at high risk of intracranial bleeding in the opinion of the investigator 2. 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) 3. Contraindication to anticoagulation in the opinion of the investigator 4. Life expectancy of \< 6 months 5. Part 1 participants with cancer and Part 2 additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent inhibition of Factor XI functional Coagulant activity (FXI:C) | Approximately 3 months | Part 1 |
| Fold change from baseline in activated Partial Thromboplastin Time (aPTT) | Approximately 3 months | Part 1 |
| Functional REGN7508 concentration | Approximately 3 months | Part 1 |
| Factor XI (FXI) concentration | Approximately 3 months | Part 1 |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Up to approximately 3.5 years | Part 1 and Part 2 |
| Magnitude of ADA to REGN7508 | Up to approximately 3.5 years | Part 1 and Part 2 |
| Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal]) | Up to approximately 3.5 years | Part 2 |
| Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery]) | Up to approximately 3.5 years | Part 2 |
| Time-to-first centrally adjudicated event of VTE-related death | Up to approximately 3.5 years | Part 2 |
| Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE | Up to approximately 3.5 years | Part 2 |
| Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE) | Up to approximately 3.5 years | Part 2 |
| 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)] | Up to approximately 3.5 years | Part 2 |
| Occurrence of TEAEs | Up to approximately 3.5 years | Part 2 |
| Severity of TEAEs | Up to 3.5 approximately years | Part 2 |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed