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

NCT04072068 | Completed Phase 4

• 1 other identifier: GOIRC-05-2018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 18

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.

Conditions

Thromboembolism; Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluate the compliance to Edoxaban treatment

  24 months

• Evaluate the safety of edoxaban treatment

  24 months

Study Arms (1)

Edoxaban

EXPERIMENTAL

edoxaban 60 mg daily

Drug: Edoxaban

Interventions

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.

Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead

Study Sites (18)

Presidio Ospedaliero SS. Antonio e Biagio

Alessandria, Italy

Location

Istituto Tumori di Bari

Bari, Italy

Location

Azienda Ospedalier Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale S.Giacomo

Castelfranco Veneto, Italy

Location

ARNAS Garibaldi

Catania, Italy

Location

Istituti Ospitalieri di Cremona

Cremona, Italy

Location

Ospedale di Faenza

Faenza, Italy

Location

Ospedale Civile di Guastalla

Guastalla, Italy

Location

Ospedale Mater Salutis

Legnago, Italy

Location

Istituto Nazionale dei Tumori di Milano

Milan, Italy

Location

Ospedali Monaldi Cotugno

Napoli, Italy

Location

Istituto Oncologico Veneto - IRCCS

Padua, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Location

AUSL/IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Ospedale degli Infermi

Rimini, Italy

Location

ASST Valleolona, PO Saronno

Saronno, Italy

Location

Ospedale Mauriziano

Torino, Italy

Location

Ospedale Molinette

Torino, Italy

Location

MeSH Terms

Conditions

Thromboembolism; Neoplasms

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carmine Pinto, MD

  Gruppo Oncologico Italiano di Ricerca Clinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: June 27, 2019
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (18)