Spots Global Cancer Trial Database for Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
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Trial Identification
Brief Title: Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
Official Title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
Study ID: NCT02585713
Study Description
Brief Summary: This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. 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. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism. ADAM-VTE
Detailed Description: PRIMARY OBJECTIVES: I. Any episode of major bleeding including fatal bleeding. SECONDARY OBJECTIVES: I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism. II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180. ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180. After completion of study treatment, patients are followed up at 3 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New Hampshire Oncology Hematology PA-Hooksett, Hooksett, New Hampshire, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal, Pinehurst, North Carolina, United States
Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Guthrie Medical Group PC-Robert Packer Hospital, Sayre, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Contact Details
Name: Robert McBane
Affiliation: Academic and Community Cancer Research United
Role: PRINCIPAL_INVESTIGATOR
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