A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 85

Inclusion Criteria

• Male or female subjects >=18 years old or another legal maturity age according
to the country of residence
• Confirmed diagnosis of cancer (by histology or adequate imaging modality),
other than basal-cell or squamous-cell carcinoma of the skin alone with one of
the following:
o Active cancer, defined as either locally active, regionally invasive,
or metastatic cancer at the time of randomization, and/oro Currently receiving
or having received anticancer therapy (radiotherapy, chemotherapy, hormonal
therapy, any kind of targeted therapy or any other anticancer therapy) in the
last 6 months.
• Confirmed symptomatic or incidental proximal lower limb acute DVT (i.e.,
popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a
confirmed symptomatic PE, or an incidental PE
in a segmental, or larger pulmonary artery. Patients are eligible within 72
hours from diagnosis of the qualifying VTE.
• Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months
is indicated.
• Able to provide written informed consent.

Exclusion Criteria

• Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to
treat the current (index) occurrence of DVT and/or PE
• More than 72 hours of pre-treatment with therapeutic doses of UFH, LMWH,
fondaparinux, DOAC, or other anticoagulants
• An indication to continue treatment with therapeutic doses of an
anticoagulant other than that used for VTE treatment prior to randomization
(e.g., atrial fibrillation, mechanical heart valve, prior
VTE)
• Platelet count <50,000/mm3
• PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg
or shock)
• Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4
weeks preceding screening
• Brain trauma, or a cerebral or a spinal cord surgery in the 4 weeks preceding
screening
• Need for aspirin in a dosage of more than 100 mg/per day or any other
antiplatelet agent alone or in combination with aspirin
• Primary brain cancer or untreated intracranial metastases
• Acute myeloid or lymphoid leukemia
• Bleeding requiring medical attention at the time of randomization or in the
preceding 4 weeks
• Planned major surgery at baseline
• Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at
screening
• Life expectancy <3 months at randomization
• Calculated creatinine clearance (CrCl) <30 mL/min
• Hemoglobin less than 8 g/dL
• Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase level 3 times or more and/or bilirubin level 2 times or more
higher the upper

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess whether abelacimab is<br /><br>non-inferior to apixaban for preventing VTE recurrence at 6 months post<br /><br>andomization in patients with cancer and recently diagnosed VTE. If non-<br /><br>nferiority is demonstrated, then superiority will be assessed.</p><br>

Secondary Outcome Measures