NCT04817189 - Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | Biotech Hunter

Enrollment

414

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

July 2, 2024

Study Completion Date

July 2, 2024

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

NEPA (300mg netupitant/0.5mg palonosetron)

Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.

DRUG

Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)

Standard of care will be administered on Day 1 of each cycle.

DRUG

Dexamethasone, 8 mg (oral) or equivalent IV dose

Dexamethasone (8 mg) will be administered on Day 1 of each cycle.

Trial Locations (19)

14059

Thomayerova nemocnice, Prague

15006

Complejo Hospitalario Universitario de A Coruña, A Coruña

28007

Hospital General Universitario Gregorio Marañón, Madrid

37007

Hospital Universitario de Salamanca, Salamanca

Unknown

Shanghai Chest Hospital, Shanghai

Shanghai Ninth People´s Hospital, Shanghai

Shanghai Obstetrics and Gynecology Hospital, Shanghai

General University Hospital in Prague, Prague

Evang. Kliniken Essen-Mitte, Essen

Universitätsmedizin Mannheim, Mannheim

München Klinik Neuperlach, München

Frauenklinik St. Louise, Paderborn

Klinikum Ernst von Bergmann gemeinnützige GmbH, Potsdam

Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of Athens, Athens

General University Hospital of Heraklion, Heraklion

University Hospital Basel, Basel

Swiss Medical Network - Clinique de Genolier, Genolier

The Royal Marsden Hospital, London

0802

Hospital de la Santa Creu i Sant Pau, Barcelona