RecruitingPhase 2

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

Greece, Poland95 participantsStarted 2025-07-07

Plain-language 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

Who can participate

Age range0 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric patient in compliance with the local laws and regulations. In addition, the signed children's Assent Form according to local requirements.
✓. Male or female in- or out-patient from 0 months (newborns) to \<18 years on the date of enrolment (Day 1).
✓. Cohort 1: Patient \< 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg.
✓. Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
✓. Patient naïve or non-naïve to chemotherapy, with histologically and/or cytologically (or imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.
✓. Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC.
✓. For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.
✓. For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.

Exclusion criteria

What they're measuring

COHORT 1 Neptupitant exposure parameter

Timeframe: From time zero ( start of IV NEPA infusion) to maximum 168 hours

COHORT 1 Neptupitant exposure

Timeframe: From time zero ( start of IV NEPA infusion) to maximum 168 hours

COHORT 2 monitoring of AEs (safety and tolerability of IV NEPA)

Timeframe: Up to 31 days

Trial details

NCT IDNCT06904235

SponsorHelsinn Healthcare SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Tulla Spinelli Head of Clinical Affairs, PharmD, PhD

+41919852121 tulla.spinelli@helsinn.com

View on ClinicalTrials.gov More Nausea and Vomiting Chemotherapy-Induced trials

Plain-language summary

Who can participate

Age range0 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric patient in compliance with the local laws and regulations. In addition, the signed children's Assent Form according to local requirements.
✓. Male or female in- or out-patient from 0 months (newborns) to \<18 years on the date of enrolment (Day 1).
✓. Cohort 1: Patient \< 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg.
✓. Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
✓. Patient naïve or non-naïve to chemotherapy, with histologically and/or cytologically (or imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.
✓. Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC.
✓. For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.
✓. For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.

Exclusion criteria

What they're measuring

COHORT 1 Neptupitant exposure parameter

Timeframe: From time zero ( start of IV NEPA infusion) to maximum 168 hours

COHORT 1 Neptupitant exposure

Timeframe: From time zero ( start of IV NEPA infusion) to maximum 168 hours

COHORT 2 monitoring of AEs (safety and tolerability of IV NEPA)

Timeframe: Up to 31 days