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

Primary Purpose

Thromboembolism, Cancer

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Edoxaban
Sponsored by
Gruppo Oncologico Italiano di Ricerca Clinica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Edoxaban

Arm Description

edoxaban 60 mg daily

Outcomes

Primary Outcome Measures

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).
Quality of life questionnaire
Quality of life will be evaluated using validate quality of life questionnaires.

Secondary Outcome Measures

Evaluate the compliance to Edoxaban treatment
For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose.
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.

Full Information

First Posted
August 22, 2019
Last Updated
May 26, 2023
Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
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1. Study Identification

Unique Protocol Identification Number
NCT04072068
Brief Title
Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban
Arm Type
Experimental
Arm Description
edoxaban 60 mg daily
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the impact of edoxaban related adverse events on antineoplastic therapy
Description
Percentage of antineoplastic therapy delays/interruption due to ADR related to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions).
Time Frame
24 months
Title
Quality of life questionnaire
Description
Quality of life will be evaluated using validate quality of life questionnaires.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Evaluate the compliance to Edoxaban treatment
Description
For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose.
Time Frame
24 months
Title
Evaluate the safety of edoxaban treatment
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmine Pinto, MD
Organizational Affiliation
Gruppo Oncologico Italiano di Ricerca Clinica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presidio Ospedaliero SS. Antonio e Biagio
City
Alessandria
Country
Italy
Facility Name
Istituto Tumori di Bari
City
Bari
Country
Italy
Facility Name
Azienda Ospedalier Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Ospedale S.Giacomo
City
Castelfranco Veneto
Country
Italy
Facility Name
ARNAS Garibaldi
City
Catania
Country
Italy
Facility Name
Istituti Ospitalieri di Cremona
City
Cremona
Country
Italy
Facility Name
Ospedale di Faenza
City
Faenza
Country
Italy
Facility Name
Ospedale Civile di Guastalla
City
Guastalla
Country
Italy
Facility Name
Ospedale Mater Salutis
City
Legnago
Country
Italy
Facility Name
Istituto Nazionale dei Tumori di Milano
City
Milano
Country
Italy
Facility Name
Ospedali Monaldi Cotugno
City
Napoli
Country
Italy
Facility Name
Istituto Oncologico Veneto - IRCCS
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
Country
Italy
Facility Name
AUSL/IRCCS di Reggio Emilia
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
Country
Italy
Facility Name
ASST Valleolona, PO Saronno
City
Saronno
Country
Italy
Facility Name
Ospedale Mauriziano
City
Torino
Country
Italy
Facility Name
Ospedale Molinette
City
Torino
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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