Single Dose of MK-0517 for Prevention of CINV in Paediatric Subjects
Research type
Research Study
Full title
A Phase III, Randomised, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0517/Fosaprepitant and Ondansetron Versus Ondansetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Paediatric Subjects Receiving Emetogenic Chemotherapy
IRAS ID
183603
Contact name
Elizabeth Martin
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2014-001783-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 6 days
Research summary
Nausea and vomiting remains a major problem for children undergoing chemotherapy despite the wide use of 5-HT3 antagonists (such as ondansetron) for the prevention of chemotherapy induced nausea and vomiting (CINV).
Fosaprepitant (also known as MK0517) is an intravenous (IV) version of an approved oral drug known as aprepitant which is given over three days for the prevention of CINV in adults. In adults a single IV dose of fosaprepitant 150 mg plus 5-HT3 antagonist plus corticosteroid, has shown non-inferiority to the 3-day oral aprepitant regimen. Fosaprepitant 150 mg has been approved in many countries worldwide (including the UK) for the prevention of CINV in adults but is not yet approved for use in children.
This study will enroll 180 children (age birth to 17 years) scheduled to receive chemotherapy associated with moderate or high risk of causing nausea and vomiting, or chemotherapy agent(s) not previously tolerated due to vomiting.
The study will evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone. The main objective of this study will be assessed during chemotherapy Cycle 1. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, either IV fosaprepitant + IV ondansetron or placebo + IV ondansetron. Participants will complete a Patient Diary for the 120 hours following the start of chemotherapy and will be followed for 14 days after study treatment. Participants will have 4 clinic visits and phone/direct contact will be made on Days 2-5 of Cycle 1.
After Cycle 1, participants may have an option to receive open label fosaprepitant for up to 5 more cycles.
The company that makes fosaprepitant is the study sponsor. It is anticipated that 2 UK NHS hospital sites will participate in the study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0407
Date of REC Opinion
6 Nov 2015
REC opinion
Further Information Favourable Opinion