A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

Launched by ANTHOS THERAPEUTICS, INC. · Dec 23, 2021

Keywords

ClinConnect Summary

This clinical trial, called the ASTER study, is looking at how well a new medication called abelacimab works compared to a standard treatment, apixaban, for patients with blood clots related to cancer. Specifically, the study focuses on patients who have experienced venous thromboembolism (VTE), which includes conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). This Phase 3 trial is currently recruiting patients aged 18 and older who have been diagnosed with cancer and have a confirmed case of DVT or PE.

Eligible participants will be asked to provide written consent and will receive either abelacimab or apixaban as part of the study. Throughout the trial, they will be monitored for the recurrence of blood clots and any bleeding complications. It’s important to note that certain medical conditions and treatments may exclude individuals from participating, so potential participants should discuss their medical history with their healthcare provider to see if they qualify. This trial offers a chance to contribute to important research that may improve treatment options for others with cancer-associated blood clots.

Gender

ALL

Eligibility criteria

• 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 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 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
• 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 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 VTE treatment prior to randomization (e.g., atrial fibrillation \[AF\], mechanical heart valve, prior VTE)
• • Platelet count \<50,000/mm3 at the screening visit
• • 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 or spinal procedures such as lumbar puncture or epidural/spinal anesthesia 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 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 \<8 g/dL at the screening visit
• • Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) 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 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