Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000043850
- Lead Sponsor
- Division of lower GI, department of surgery, Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Patients who are bleeding (2) Patients with complications that may cause bleeding 3) Patients using heparin, low molecular weight heparin, danaparoid, antithrombin (argatroban, etc.), oral anticoagulant (warfarin), thrombolytic, antiplatelet agents (ticlopidine, clopidogrel, aspirin, etc.) Patients who are taking strong inducers or inhibitors of CYP3A4. (5) Patients who do not have major organ function. Patients who do not meet any of the following criteria (6) Patients with a known history of hypersensitivity to any component of the study drug or any drug used in the chemotherapy regimen (7) Patients with a history of cerebral hemorrhage (viii) Patients with contrast media allergy (9) Patients with acute bacterial endocarditis (10) Patients for whom edoxaban cannot be administered according to the package insert (11) Other patients deemed inappropriate for the study by the principal investigator or sub-investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-Xa activity in the blood during chemotherapy for colorectal cancer
- Secondary Outcome Measures
Name Time Method