Safety, pharmacokinetics, and efficacy of palonosetron in pediatric patients: A multicenter, stratified, double-blind, phase 3, randomized study

9570 Background: A single intravenous (IV) dose of palonosetron (PALO) 0.25 mg is used in the prevention of acute chemotherapy-induced nausea and vomiting (CINV) after highly (HEC) and moderately emetogenic chemotherapy (MEC) and in the prevention of delayed CINV after MEC. Since younger age is a risk factor that increases the likelihood of CINV, we conducted this study to explore the safety, pharmacokinetics (PK) and efficacy of PALO in pediatric patients receiving MEC (32% of patients) or HEC (68%). Methods: Sixty pediatric patients in 2 age strata, ages 2–11 and 12–17 years, were randomized to receive a single IV dose of PALO 3 mcg/kg (max total dose = 0.25 mg) or 10 mcg/kg (max total dose = 0.75 mg), with no concomitant antiemetics prior to MEC or HEC. The same doses were used in 12 additional younger patients (age range: 28 days - 23 months) treated in an open-label fashion. Safety, assessed as incidence of adverse events (AEs), was the primary between-group analysis endpoint. Plasma concentrations, ...