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

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 27, 2019

Primary Completion Date

March 8, 2022

Study Completion Date

March 8, 2022

Conditions
ThromboembolismCancer
Interventions
DRUG

Edoxaban

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.

Trial Locations (18)

Unknown

Presidio Ospedaliero SS. Antonio e Biagio, Alessandria

Istituto Tumori di Bari, Bari

Azienda Ospedalier Spedali Civili di Brescia, Brescia

Ospedale S.Giacomo, Castelfranco Veneto

ARNAS Garibaldi, Catania

Istituti Ospitalieri di Cremona, Cremona

Ospedale di Faenza, Faenza

Ospedale Civile di Guastalla, Guastalla

Ospedale Mater Salutis, Legnago

Istituto Nazionale dei Tumori di Milano, Milan

Ospedali Monaldi Cotugno, Napoli

Istituto Oncologico Veneto - IRCCS, Padua

Azienda Ospedaliero-Universitaria di Parma, Parma

AUSL/IRCCS di Reggio Emilia, Reggio Emilia

Ospedale degli Infermi, Rimini

ASST Valleolona, PO Saronno, Saronno

Ospedale Mauriziano, Torino

Ospedale Molinette, Torino

All Listed Sponsors
lead

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER

NCT04072068 - Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy | Biotech Hunter | Biotech Hunter