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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04072068
Other study ID # GOIRC-05-2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 27, 2019
Est. completion date March 8, 2022

Study information

Verified date May 2023
Source Gruppo Oncologico Italiano di Ricerca Clinica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 8, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Edoxaban
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.

Locations

Country Name City State
Italy Presidio Ospedaliero SS. Antonio e Biagio Alessandria
Italy Istituto Tumori di Bari 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 Milano
Italy Ospedali Monaldi Cotugno Napoli
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

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Oncologico Italiano di Ricerca Clinica

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Quality of life questionnaire Quality of life will be evaluated using validate quality of life questionnaires. 24 months
Secondary 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
Secondary Evaluate the safety of edoxaban treatment 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
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