drugset / Trial / NCT01697579
Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to \<17 years of age. Fosaprepitant is a prodrug to aprepitant. All participants who completed the randomized Cycle 1 could elect to receive open-label fosaprepitant during optional Cycles 2-6.
Timeline
- Start
- 2012-12-13
- Primary completion
- 2016-11-21
- Completion
- 2016-11-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosaprepitant | Other / unclassified | 0.4 mg/kg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 1.2 mg/kg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 3 mg/kg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 5 mg/kg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 20 mg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 60 mg | Intravenous |
| Subject | Fosaprepitant | Other / unclassified | 150 mg | Intravenous |
| Background | Ondansetron | Other / unclassified | 0.15 mg/kg | Intravenous |