EUCTR2021-003076-14-ATActive, not recruitingPhase 1
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
Anthos Therapeutics0 sites1,655 target enrollmentStarted: June 27, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,655
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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:
- •oActive cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or
- •oCurrently 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 DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic or incidental PE of a segmental, or larger pulmonary artery, and/or a confirmed symptomatic or incidental PE of two or more subsegmental pulmonary arteries. Patients are eligible within 120 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 828
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 827
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 120 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 at the screening visit
- •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 or spinal procedures such as lumbar puncture or epidural/spinal anesthesia 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 at baseline
- •Acute myeloid or lymphoid leukemia at baseline
- •Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
- •Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization.
- •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) at the screening visit
- •Hemoglobin less than 8 g/dL at the screening visit
- •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 limit of the normal range at the screening visit 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 dalteparin 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 dalteparin 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 its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
- •Subjects with any condition that as judged by the Investigator 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 effect has returned to baseline, whichever is longer. Participation in academic non-interventional or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.
Investigators
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