A Phase IV Study on Impact of Edoxaban Treatment in Italian Cancer Patients With Venous Thromboembolism (EDOI Cancer Study) During Antineoplastic Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 18
- Primary Endpoint
- Evaluate the impact of edoxaban related adverse events on antineoplastic therapy
Study Overview
Brief Summary
This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult subjects presenting with VTE (venous thromboembolism) associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin). Cancer diagnosis should be done within two years prior to VTE.
- •Patient must be receiving systemic antineoplastic therapy (such as chemotherapy, target therapy, immunotherapy, hormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy.
Exclusion Criteria
- •Hypersensitivity to the active substance or to any of the excipients;
- •Clinically significant active bleeding;
- •Hepatic disease associated with coagulopathy and clinically relevant bleeding risk;
- •Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
- •Uncontrolled severe hypertension;
- •Concomitant treatment with any other anticoagulants
- •Pregnancy and breast-feeding.
Arms & Interventions
Edoxaban
edoxaban 60 mg daily
Intervention: Edoxaban (Drug)
Outcomes
Primary Outcomes
Evaluate the impact of edoxaban related adverse events on antineoplastic therapy
Time Frame: 24 months
Percentage of antineoplastic therapy delays/interruption due to ADR related to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions).
Quality of life questionnaire
Time Frame: 24 months
Quality of life will be evaluated using validate quality of life questionnaires.
Secondary Outcomes
- Evaluate the compliance to Edoxaban treatment(24 months)
- Evaluate the safety of edoxaban treatment(24 months)