This early phase I trial tests the safety and side effects of dose adjusted apixaban and how well it works in treating blood clots (venous thromboembolism) in cancer patients with a low number of platelets (thrombocytopenia). Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism and those with thrombocytopenia are at a high risk of developing major bleeding, making treatment challenging. Treatment usually includes drugs that are given by injection to prevent or reduce blood clot formation (anticoagulation), with platelet transfusion support as needed. Apixaban is an oral drug that blocks the action of coagulation factor Xa and may prevent blood clots from forming and may treat blood clots that have already formed. The dose of apixaban will be adjusted based on the number of platelets and perceived risk of bleeding. Giving dose adjusted apixaban may be safe, tolerable, and/or effective in treating venous thromboembolism and preventing bleeding events in cancer patients with thrombocytopenia.
Additional locations may be listed on ClinicalTrials.gov for NCT06886516.
Locations matching your search criteria
United States
Massachusetts
Boston
Beth Israel Deaconess Medical CenterStatus: Active
Contact: Rushad Patell
Phone: 617-667-9179
PRIMARY OBJECTIVE:
I. To determine the feasibility of conducting a clinical study using a novel dose-adjusted regimen of apixaban for the management of patients with acute cancer associated thrombosis and thrombocytopenia.
SECONDARY OBJECTIVES:
I. Enrolled patients who received at least 1 dose of apixaban. (Feasibility)
II. Drug compliance adherence. (Feasibility)
III. Adherence to platelet count monitoring plan. (Feasibility)
IV. Number of patients who complete entire study. (Feasibility)
V. Safety outcomes will be included during the trial-drug period through 72 hours after the last dose is administered. (Safety)
VI. Major bleeding. (Safety)
VII. Clinically relevant non-major bleeding. (Safety)
VIII. Recurrent venous thromboembolism (VTE) (including pulmonary embolism and lower extremity deep vein thrombosis). (Safety)
OUTLINE:
Patients receive apixaban orally (PO) twice daily (BID) on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed for up to 6 weeks.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorRushad Patell