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

Phase 4

Completed

• Conditions: Thromboembolism; Cancer
• Interventions: Drug: Edoxaban

• Registration Number: NCT04072068
• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Edoxaban	Edoxaban	edoxaban 60 mg daily

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire	24 months	Quality of life will be evaluated using validate quality of life questionnaires.
Evaluate the impact of edoxaban related adverse events on antineoplastic therapy	24 months	Percentage of antineoplastic therapy delays/interruption due to ADR related to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions).

Secondary Outcome Measures

Name	Time	Method
Evaluate the compliance to Edoxaban treatment	24 months	For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose.
Evaluate the safety of edoxaban treatment	24 months	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.

Trial Locations

Locations (18)

Azienda Ospedalier Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Ospedale S.Giacomo; 🇮🇹 Castelfranco Veneto, Italy

Ospedale di Faenza; 🇮🇹 Faenza, Italy

Istituti Ospitalieri di Cremona; 🇮🇹 Cremona, Italy

Ospedale Mater Salutis; 🇮🇹 Legnago, Italy

Istituto Tumori di Bari; 🇮🇹 Bari, Italy

Istituto Oncologico Veneto - IRCCS; 🇮🇹 Padova, Italy

ASST Valleolona, PO Saronno; 🇮🇹 Saronno, Italy

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, Italy

Ospedali Monaldi Cotugno; 🇮🇹 Napoli, Italy

Ospedale degli Infermi; 🇮🇹 Rimini, Italy

Ospedale Mauriziano; 🇮🇹 Torino, Italy

ARNAS Garibaldi; 🇮🇹 Catania, Italy

Presidio Ospedaliero SS. Antonio e Biagio; 🇮🇹 Alessandria, Italy

Ospedale Civile di Guastalla; 🇮🇹 Guastalla, Italy

Istituto Nazionale dei Tumori di Milano; 🇮🇹 Milano, Italy

AUSL/IRCCS di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy