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

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

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 Overview

• Status: Completed
• Conditions: Cancer; Thromboembolism
• Intervention / Treatment: Drug: Edoxaban

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carmine Pinto, MD; Phone Number: +390522295181; Email: pinto.carmine@ausl.re.it

Study Locations

• Italy
  • Alessandria, Italy
    • Presidio Ospedaliero SS. Antonio e Biagio
  • Bari, Italy
    • Istituto Tumori di Bari
  • Brescia, Italy
    • Azienda Ospedalier Spedali Civili di Brescia
  • Castelfranco Veneto, Italy
    • Ospedale S.Giacomo
  • Catania, Italy
    • ARNAS Garibaldi
  • Cremona, Italy
    • Istituti Ospitalieri di Cremona
  • Faenza, Italy
    • Ospedale di Faenza
  • Guastalla, Italy
    • Ospedale Civile di Guastalla
  • Legnago, Italy
    • Ospedale Mater Salutis
  • Milano, Italy
    • Istituto Nazionale dei Tumori di Milano
  • Napoli, Italy
    • Ospedali Monaldi Cotugno
  • Padova, Italy
    • Istituto Oncologico Veneto - IRCCS
  • Parma, Italy
    • Azienda Ospedaliero-Universitaria di Parma
  • Reggio Emilia, Italy
    • AUSL/IRCCS di Reggio Emilia
  • Rimini, Italy
    • Ospedale degli Infermi
  • Saronno, Italy
    • ASST Valleolona, PO Saronno
  • Torino, Italy
    • Ospedale Molinette
  • Torino, Italy
    • Ospedale Mauriziano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Edoxaban; edoxaban 60 mg daily

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
• Investigators: Principal Investigator: Carmine Pinto, MD, Gruppo Oncologico Italiano di Ricerca Clinica

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: GOIRC-05-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No