drugset / Trial / NCT04054193

Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

NCT04054193

Phase 4 Completed 103 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.

Timeline

Start
2019-09-09
Primary completion
2021-02-11
Completion
2021-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject fosaprepitant dimeglumine Unknown 80 mg Intravenous
Background Dexamethasone Small molecule Oral