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

  • STATUS
    Recruiting
  • End date
    Jan 24, 2022
  • participants needed
    300
  • sponsor
    Gruppo Oncologico Italiano di Ricerca Clinica
Updated on 24 January 2021
heparin
cancer
carcinoma
non-melanoma skin cancer
cancer diagnosis
primary cancer
antineoplastic agents
venous thromboembolism
edoxaban

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.

Details
Condition Cancer, Thromboembolism, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, Thromboembolic Events, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, thromboembolic disease, thromboembolic event
Treatment Edoxaban
Clinical Study IdentifierNCT04072068
SponsorGruppo Oncologico Italiano di Ricerca Clinica
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cancer (Pediatric) or Thromboembolism or Cancer/Tumors or Cancer or Ewing's Family Tumors or Neoplasms?
Do you have any of these conditions: thromboembolic event or primary malignant neoplasm or malignant tumor or malignancy or Cancer (Pediatric) or Thromboembolic Events or Cancer or thromb...?
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
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