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)
Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. The two most common treatments today are low molecular weight heparin (LMWH) and direct anticoagulants (DOACs), in which each has limitations. DOACs are administered orally and are seen as a more convenient alternative though associated with bleeding risk; further, some cancer patients have difficulty swallowing or develop vomiting which leads to unpredictable pharmacodynamic effects with oral therapy. The ANT-007 study will compare treatment with abelacimab monthly administration to apixaban twice daily administration over a 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,150
Abelacimab 150 mg
Apixaban 10 mg followed by 5 mg
Time to first event of centrally adjudicated VTE recurrence
Time to first event of centrally adjudicated venous thromboembolism (VTE) recurrence
Time frame: Up to 6 months
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events
Time to first adjudicated major or clinically relevant non-major (CRNM) bleeding event
Time frame: Up to 6 months
Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events
Time to first adjudicated venous thromboembolism (VTE) or bleeding event
Time frame: Up to 6 months
Time to event of permanent treatment discontinuation not due to death
Time to permanent discontinuation not due to death
Time frame: Up to 6 months
Time to first event of ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events
Time to first adjudicated clinically relevant non-major (CRNM) bleeding event
Time frame: Up to 6 months
Time to first event of ISTH-adjudicated major bleeding events
Time to first adjudicated major bleeding event
Time frame: Up to 6 months
Time to first event of GI ISTH-adjudicated major and CRNM bleeding events
Time to first adjudicated gastrointestinal (GI) major and clinically relevant non-major (CRNM) bleeding event
Time frame: Up to 6 months
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Washington DC VAMC
Washington D.C., District of Columbia, United States
University of Miami Health
Miami, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
...and 199 more locations
All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient-years
Time frame: Up to 6 months
For patients treated with abelacimab: percent with injection site reactions/severity, hypersensitivity reactions/severity, anti-drug antibody formation, neutralizing antibody
Time frame: Up to 6 months