At a glance
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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
In Brief
A Phase 4 clinical trial evaluating Fosaprepitant Dimeglumine, 5-HT3 antagonist, and 1 other intervention for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 103 participants across 26 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
All participants received an oral 5-hydroxytryptamine (serotonin; \[5-HT\]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.
Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.