A Phase IV study on impact of Edoxaban treatment in Italian cancer patients with venous thromboembolism during antineoplastic therapy

Phase 1

• Conditions: Venous thromboembolism event associated with cancer; MedDRA version: 21.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; MedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003833-14-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Adult subjects presenting with VTE associated with cancer.
- Patient must be receiving sistemic antineoplastic therapy (such as chemotherapy, target therapy, immuntherapy, ormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

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 clinical trial of medicinal product
• Study Design: Not specified