At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC
In Brief
A Phase 3 clinical trial evaluating Palonosetron, Ondansetron, and 2 other interventions for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 502 participants across 67 sites in 16 countries.
Detailed Summary
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.
Study Details
Timeline
Interventions
Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg