ADAPTiON: Apixaban Dose Adjustment in Patient With Thrombocytopenia in ONcology
Summary
This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)
Detailed description
This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). This study is a feasibility study, which is the first-time investigators are examining this drug, Apixaban, for cancer-associate VTE or thrombocytopenia. Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The U.S. Food and Drug Administration (FDA) has approved apixaban as a treatment option for venous thromboembolism (VTE) and stroke prevention in patients with atrial fibrillation (irregular and fast heartbeat). This study is investigating apixaban taken by mouth (with adjusted doses) as a treatment for VTE in participants with active malignancies (cancer) and thrombocytopenia which has not been studied or FDA approved. The research study procedures include screening for eligibility, in-clinic visits, and blood tests. Participants will receive study treatment for 90 days and will be followed for 6 weeks after stopping study treatment. It is expected that about 30 people will take part in this research study.
Arms & interventions
- DrugApixaban
A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.
Outcome measures
Primary
Study Enrollment
Study enrollment is defined as documentation of informed consent for participants approached.
Time frame: Up to 5 years
Secondary
Rate of Enrolled Participants With Administration of at Least 1 Dose of Apixaban
Time frame: Up to 3 months
Study Drug Adherence Rate
Time frame: Up to 3 months
Platelet Count Monitoring Plan Adherence Rate
Time frame: Up to 3 months
Study Completion Rate
Time frame: Up to 3 months
Major Bleeding Rate
Time frame: Up to 3 months
Clinically Relevant Non-Major Bleeding Rate
Time frame: Up to 3 months
Recurrent Venous Thromboembolism Rate (VTE)
Time frame: Up to 3 months
Eligibility criteria
Study locations (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215