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

NCT06904235 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-03-31

No results posted yet for this study

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

Conditions

  • Nausea and Vomiting Chemotherapy-Induced
  • Nausea Post Chemotherapy

Interventions

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)

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Greece
  • Poland
  • Romania
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06904235 on ClinicalTrials.gov