PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of
oral netupitant administered concomitantly with oral palonosetron in pediatric cancer
patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy.
Two different netupitant dosages will be tested in patients aged from 3 months to < 18 years:
1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant
doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to
a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the
pediatric population. The primary objective is to investigate the PK/PD relationship between
netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single
oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer
patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy
(HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients
with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (>
24-120 h after the start of chemotherapy on Day 1).
The secondary objectives are to assess the safety and tolerability after single oral
administration of netupitant given concomitantly with a single oral administration of
palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron
at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of
netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be
enrolled in the study.