NCT06904235

Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)

A Multicentre, Multinational, Pharmacokinetic, Safety, and Efficacy Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC). A 2-part Study With Phase 2, Open-label, Randomised, Single-dose IV NEPA vs Fosaprepitant/Ondansetron in Single-day HEC and Repeated-dose IV NEPA in Multi-day HEC (Part I, Single Cycle) and With Phase 3, Double-blind, Randomised, Repeated-dose IV NEPA vs Fosaprepitant/Ondansetron in Multi-day HEC (Part II, Repeated Cycles)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 0 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA) was developed. The two substances are: palonosetron, an antagonist of 5 HT3 receptors, and fosnetupitant, an antagonist of NK1 receptors that transforms into netupitant in the body. The medication is administered through intravenous injection (IV- drip). This study is built from 2 parts: Part 1: phase 2, open label Part 2: phase 3 double blind The detailed description, study design, study milestones and eligibility criteria will reflect the Part 1 requirements

Detailed description

Part I of the study is a Phase 2, open-label, randomised (for Cohort 1 only), single chemotherapy cycle study which will compare single-dose of IV NEPA to another treatment (fosaprepitant/ondansetron) considered as a standard of care, in patients receiving single-day chemotherapy that has a high possibility to generate a vomiting episode (HEC) (Cohort 1) and assess repeated dose of IV NEPA in patients receiving multi day HEC chemotherapy (Cohort 2). Because this will be the first study testing the IV NEPA in children, Part I will enroll patients from older to younger age groups with safety checks before moving to the next group.

Conditions

• Nausea and Vomiting Chemotherapy-Induced
• Nausea Post Chemotherapy

Interventions

Type	Name	Description
DRUG	IV NEPA (fosnetupitant/palonosetron)	In NEPA-22-01, different body weight-based dosages of IV NEPA will be applied to patients below and over 3 months of age: Formulation A (for patients ≥3 months of age; 235 mg fosnetupitant/1.5 mg palonosetron per vial) or Formulation B (for patients \<3 months of age; 235 mg fosnetupitant/2.5 mg palonosetron per vial).
DRUG	Reference Treatment: IV ondansetron infusion	IV Ondansetron Dosing Regimen * Day 1 (before start of chemotherapy): One 30-min infusion of 0.15 mg/kg (ondansetron maximum dose: 8 mg per administration) * Day 1 at 4 h and 8 h after the end of first administration: Two 30-min infusions of 0.15 mg/kg (ondansetron maximum dose: 8 mg per administration)
DRUG	Reference Treatment: IV fosaprepitant infusion	Fosaprepitant IV Dosing Regimen * Patients aged 12 years to \<18 years: a single dose of IV fosaprepitant 150 mg * Patients aged 2 years to \<12 years: a single dose of IV fosaprepitant 4 mg/kg (maximum dose: 150 mg) * Patients aged 6 months to \<2 years: a single dose of IV fosaprepitant 5 mg/kg (maximum dose: 150 mg)

Timeline

• Start date: 2025-07-07
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-04-01
• Last updated: 2026-03-31

Locations

20 sites across 4 countries: Greece, Poland, Romania, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study