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

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

NCT Number	NCT06904235
Lead Sponsor	Helsinn Healthcare SA
Conditions	Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy
Enrollment	95 participants
Start Date	2025-07-07
Primary Completion	2027-10 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-01