drugset / Trial / NCT00818259

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

NCT00818259

Phase 1 Terminated 92 enrolled Merck Sharp & Dohme LLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.

Timeline

Start
2009-02-05
Primary completion
2014-01-20
Completion
2014-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 0.5 mg/kg Oral
Subject Aprepitant Other / unclassified 0.75 mg/kg Oral
Subject Aprepitant Other / unclassified 1 mg/kg Oral
Subject Aprepitant Other / unclassified 1.3 mg/kg Oral
Subject Aprepitant Other / unclassified 1.5 mg/kg Oral
Subject Aprepitant Other / unclassified 2 mg/kg Oral
Subject Aprepitant Other / unclassified 3 mg/kg Oral
Subject Aprepitant Other / unclassified 47 mg/m2 Oral
Subject Aprepitant Other / unclassified 74 mg/m2 Oral
Subject Aprepitant Other / unclassified 80 mg Oral
Subject Fosaprepitant Other / unclassified 3 mg/kg Intravenous
Subject Fosaprepitant Other / unclassified 115 mg Intravenous
Subject Fosaprepitant Other / unclassified 150 mg Intravenous
Background Dexamethasone Small molecule Intravenous
Comparator Ondansetron Other / unclassified Intravenous