{"entity":{"id":"nct06904235","kind":"trial","name":"Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)","aka":[],"tldr":"A phase 2 trial of Palonosetron, Ondansetron and Aprepitant (and fosaprepitant) in childhood cancers, run by Helsinn Healthcare SA, now recruiting.","summary":"Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) is a phase 2 interventional study registered as NCT06904235 by Helsinn Healthcare SA, with 95 participants planned, started 2025-07-07 and due to reach its primary completion in 2027-10. Interventions recorded: IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion and Reference Treatment: IV fosaprepitant infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06904235","url":"https://clinicaltrials.gov/study/NCT06904235"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":["antiemetic-therapy"],"targets":[],"drugs":["palonosetron","ondansetron","aprepitant"],"companies":["helsinn"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06904235","phase":"2","setting":"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)","sponsor":"Helsinn Healthcare SA","participation":[{"nct":"NCT06904235","source":"https://clinicaltrials.gov/study/NCT06904235","fetchedAt":"2026-10-07T16:55:17.578Z","studySha256":"9ed9df062b86176f0c49ff335ec6fc461f8409f35bb526ba33d10f5c85c3df0c","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-29","leadSponsor":"Helsinn Healthcare SA","collaboratorCount":0,"minimumAge":"0 Months","maximumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":95,"enrolmentType":"ESTIMATED","siteCount":20,"recruitingSiteCount":13,"countries":["Greece","Poland","Romania","Turkey (Türkiye)"]}],"started":"2025-07-07","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06904235/","neighbours":{"cancer":[{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"}],"technology":[{"id":"antiemetic-therapy","kind":"technology","name":"Antiemetics for chemotherapy-induced nausea and vomiting","route":"/technologies/antiemetic-therapy/"}],"drug":[{"id":"aprepitant","kind":"drug","name":"Aprepitant (and fosaprepitant)","route":"/drugs/aprepitant/"},{"id":"ondansetron","kind":"drug","name":"Ondansetron","route":"/drugs/ondansetron/"},{"id":"palonosetron","kind":"drug","name":"Palonosetron","route":"/drugs/palonosetron/"}],"company":[{"id":"helsinn","kind":"company","name":"Helsinn","route":"/companies/helsinn/"}]}}