Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07493304
Eligibility 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 exclusion criteria:
1. Has acute leukemia or myelodysplastic syndrome
2. Has primary brain tumor
3. Has brain metastases as described in the protocol
6. Part 1 additional exclusion criteria:
1. Has a symptomatic PE
2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07493304
Study Brief:
Protocol Section:
NCT07493304