Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study
comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE)
recurrence and bleeding in patients with cancer associated VTE (ASTER)
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
Enrollment Eligibility
Inclusion Criteria:
- Male or female subjects ≥18 years old or other legal maturity age according to the
country of residence
- Confirmed diagnosis of cancer (by histology, adequate imaging modality), other than
basal-cell or squamous-cell carcinoma of the skin alone with one of the following:
- Active cancer, defined as either locally active, regionally invasive, or
metastatic cancer at the time of randomization and/or
- 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 deep vein thrombosis
(DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava [IVC] thrombosis)
and/or a confirmed symptomatic pulmonary embolism (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) 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 VTE treatment prior to randomization (e.g., atrial fibrillation [AF],
mechanical heart valve, prior VTE)
- Platelet count <50,000/mm3
- PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or shock)
- Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within the 4 weeks
preceding screening
- Brain trauma or a cerebral or spinal cord surgery within 4 weeks of screening
- Need for aspirin in a dosage of >100 mg/day or any other antiplatelet agent alone or
in combination with aspirin
- Primary brain cancer or untreated intracranial metastases at baseline
- 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 (Cockcroft-Gault equation)
- Hemoglobin <8 g/dL
- Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) in
absence of clinical explanation
- Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite
antihypertensive treatment)
- Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly
effective contraceptive measures during the study from screening up to 3 days after
last treatment of apixaban or 100 days after administration of abelacimab (See Section
5.3.6. for highly effective contraceptive measures)
- Sexually active males with sexual partners of childbearing potential must agree to use
a condom or other reliable contraceptive measure up to 3 days after last treatment of
apixaban or 100 days after administration of abelacimab
- Pregnant or breast-feeding women
- Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P
gp
- History of hypersensitivity to any of the study drugs (including apixaban) or
excipients, to drugs of similar chemical classes, or any contraindication listed in
the label for apixaban
- Subjects with any condition that in the Investigator's judgement would place the
subject at increased risk of harm if he/she participated in the study
- Use of other investigational (not registered) drugs within 5 half-lives prior to
enrollment or until the expected pharmacodynamic(s) (PD) effect has returned to
baseline, whichever is longer. Participation in academic non-interventional studies or
interventional studies, comprising testing different strategies or different
combinations of registered drugs is permitted