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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban | Experimental | edoxaban 60 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | Every patient will receive every day edoxaban orally once a day. Edoxaban therapy will start after at least 5 days of lead-in with low-molecular-weight heparin, as per clinical practice. Edoxaban will be administered at dosage of 60 mg/day. In case of patients with body weight ≤60kg or with renal failure (creatinine clearance between 15 and 50 ml/min) or that are treated with P-gp inhibitors (cyclosporine, dronedarone, erythomycin, ketoconazole), dosage will be 30 mg/day. Patients will be treated for 6 up to 12 months with edoxaban, as per medical decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the impact of edoxaban related adverse events on antineoplastic therapy | Percentage of antineoplastic therapy delays/interruption due to ADR related to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions). | 24 months |
| Quality of life questionnaire | Quality of life will be evaluated using validate quality of life questionnaires. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the compliance to Edoxaban treatment | For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose. | 24 months |
| Evaluate the safety of edoxaban treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmine Pinto, MD | Gruppo Oncologico Italiano di Ricerca Clinica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Ospedaliero SS. Antonio e Biagio | Alessandria | Italy | ||||
| Istituto Tumori di Bari |
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The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity.
| 24 months |
| Bari |
| Italy |
| Azienda Ospedalier Spedali Civili di Brescia | Brescia | Italy |
| Ospedale S.Giacomo | Castelfranco Veneto | Italy |
| ARNAS Garibaldi | Catania | Italy |
| Istituti Ospitalieri di Cremona | Cremona | Italy |
| Ospedale di Faenza | Faenza | Italy |
| Ospedale Civile di Guastalla | Guastalla | Italy |
| Ospedale Mater Salutis | Legnago | Italy |
| Istituto Nazionale dei Tumori di Milano | Milan | Italy |
| Ospedali Monaldi Cotugno | Naples | Italy |
| Istituto Oncologico Veneto - IRCCS | Padova | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | Italy |
| AUSL/IRCCS di Reggio Emilia | Reggio Emilia | Italy |
| Ospedale degli Infermi | Rimini | Italy |
| ASST Valleolona, PO Saronno | Saronno | Italy |
| Ospedale Mauriziano | Torino | Italy |
| Ospedale Molinette | Torino | Italy |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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