3-day fosaprepitant CINV safety study in paediatric participants
Research type
Research Study
Full title
A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy
IRAS ID
265942
Contact name
Susan Picton
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-004844-43
Duration of Study in the UK
1 years, 7 months, 15 days
Research summary
Chemotherapy-induced nausea and vomiting (CINV) is one of the most undesirable side effects in patients undergoing cancer treatment. In addition to lowering quality of life, CINV can delay/reduce the amount of chemotherapy patients receive in future cycles. CINV occurs more frequently in children receiving emetogenic (nausea/vomit inducing) chemotherapy than adults.
CINV is caused by activation of receptors in the brain, e.g. the Neurokinin-1 (NK1) receptor, by chemotherapy agents. Drugs which have been developed to block the NK1 receptor such as aprepitant and fosaprepitant have been shown to be clinically effective in preventing nausea and vomiting associated with emetogenic chemotherapy. The oral drug aprepitant is approved, and considered part of standard of care for the prevention of nausea/vomiting associated with emetogenic chemotherapy in cancer patients 6 months and older. However, difficulties in administering oral medications to paediatric cancer patients meant there was a need to develop intravenously (IV) administered drugs to prevent CINV, such as fosaprepitant.
Fosaprepitant is currently approved as part of the prevention of CINV in patients 6 months and older, as part of either a 1-day or 3-consecutive days IV/IV/IV regimen. Fosaprepitant is administered intravenously, concomitantly with a 5-HT3 antagonist, with or without dexamethasone. The aim of this study is to collect additional data on the safety and tolerability of the 3 day IV/IV/IV regimen.
This phase 4 study will last approximately 19 months and will recruit approximately 100 participants 6 months to 17 years of age (inclusive) receiving emetogenic chemotherapy. The purpose of the study is to collect additional data to assess the safety and tolerability of multiple cycles of IV administration of fosaprepitant daily for 3 consecutive days.
The study is funded by Merck Sharp & Dohme Limited and will take place at 3 study centres in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0248
Date of REC Opinion
7 Oct 2019
REC opinion
Further Information Favourable Opinion