NCT01442376

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For neonates (\<28 days, full term) an open-label sub-study will be conducted to assess exposure and tolerability in this age group with escalating doses of palonosetron, starting with 3 mcg/kg to the first three or more neonates included in the study. If this dose is shown to be safe and well tolerated then the following three neonates will be treated with a dose of 10 mcg/kg. If also this dose is safe and well tolerated, then the following three neonates will be treated with a dose of 20 mcg/kg. If this last dose is also shown to be safe and well tolerated, then all the following neonates will be randomized to the main study.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron	Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
DRUG	Palonosetron	Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
DRUG	Ondansetron	Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
DRUG	Placebo to Ondansetron
DRUG	Placebo to Ondansetron
DRUG	Placebo to Palonosetron

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-09-28
• Last updated: 2014-08-07
• Results posted: 2014-07-28

Locations

67 sites across 16 countries: United States, Argentina, Austria, Bulgaria, Chile, Czechia, Estonia, France, Germany, Hungary, Peru, Poland, Romania, Russia, Serbia, Ukraine