Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy

Cancer Clinical Trial

— EDOI  

Official title:

A Phase IV Study on Impact of Edoxaban Treatment in Italian Cancer Patients With Venous Thromboembolism (EDOI Cancer Study) During Antineoplastic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072068
• Other study ID #: GOIRC-05-2018
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

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