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Nausea and Vomiting Chemotherapy-InducedPhase 2NCT06904235

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 Phase 2 study testing IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion and Reference Treatment: IV fosaprepitant infusion in people with Nausea and Vomiting Chemotherapy-Induced and Nausea Post Chemotherapy, run by Helsinn Healthcare SA at 20 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 months to 18 years
What is being tested?
IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion and Reference Treatment: IV fosaprepitant infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
20 sitesin 4 countries
Study dates
7 Jul 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The following inclusion criteria must be checked prior to study inclusion:
  • 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.
  • Cohort 2: Patient weighing at least 4 kg.
  • Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
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  • 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.
  • Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.
  • (For the level of emetogenicity of the chemotherapeutic agents, refer to the POGO January 2021 guideline).
  • 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.
  • For patient with known renal impairment: the patient may be enrolled provided the estimated glomerular filtration rate (eGFR) is ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for children <3 months old) (the eGFR should be calculated using the modified Schwartz equation) and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.
  • For patient with known history or predisposition to cardiac abnormalities: as per the Investigator's opinion, the history/predisposition should not jeopardize patient's safety during the study.
  • Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator's opinion the patient's safety is not expected to be jeopardized.
  • Female patient shall: a) not have attained menarche yet or b) have attained menarche and have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Day 1.
  • Male or female fertile patient using reliable contraceptive measures. Such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized/sterilized partner, use of a double barrier method, or sexual abstinence. The patient and his/her parent(s)/legal guardian must be counselled on the importance of avoiding pregnancy before and during the study.

Who cannot join

  • The patient and/or parent(s)/legal guardian are expected by the Investigator to be non compliant with the study procedures.
  • Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to study entry (Day 1) or within 120 h after start of chemotherapy on Day 1 (Cohort 1 patients) or within 168 h (for Cohort 2 patients receiving the last IV NEPA on Day 3) or 216 h (for Cohort 2 patients receiving the last IV NEPA on Day 5) from start of chemotherapy on Day 1.
  • Known history of allergy to any component of the study treatments or other contraindications to any NK1-RAs or 5-HT3-RAs.
  • Active infection.
  • Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.
  • Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
Show all 35Show fewer
  • Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.
  • Patient who experienced any vomiting, retching, or nausea within 24 h prior to the administration of the study treatment on Day 1 (Note: functional vomiting for infants, which is normally seen during the first 3 months of life, is not to be considered as vomiting).
  • Patient who received any drug with potential antiemetic effect within 24 h prior to administration of study treatment on Day 1, including but not limited to the following:
  • NK1-RAs (e.g., (fos)aprepitant or any other drug of this class)
  • 5-HT3-RAs (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron)
  • Benzamides (e.g., metoclopramide, alizapride)
  • Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine)
  • Benzodiazepines initiated 48 h prior to study treatment administration on Day 1 or expected to be administered within the efficacy assessment period, except for single doses of midazolam, temazepam, or triazolam
  • Butyrophenones (e.g., droperidol, haloperidol)
  • Anticholinergics (e.g., scopolamine, except the inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide)
  • Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorphenhyramine, dimenhydrinate, meclizine)
  • Domperidone
  • Mirtazapine
  • Olanzapine
  • Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone)
  • Over-the-counter (OTC) antiemetics, OTC cold medications, or OTC allergy medications
  • Herbal preparations containing ephedra or ginger
  • Patient who received palonosetron within 1 week prior to administration of study treatment on Day 1.
  • Patient receiving systemic corticosteroid therapy above 0.14mg/kg or >10 mg of prednisone daily or equivalent.
  • Exception:
  • Dexamethasone for the prevention of CINV is permitted in association with the study treatment (Test Treatment and Reference Treatment) as per standard of care and applicable guidelines, provided its dosage is reduced by 50% in consideration of known interactions with various NK1 RAs, including fosaprepitant and fosnetupitant.
  • Patient aged <6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age or indication) within 90 days prior to Day 1, or patient aged ≥6 years who received any investigational drug within 30 days prior to Day 1, or patient any age who is expected to receive investigational drugs prior to study completion.
  • Intake of alcohol, food, or beverages (e.g., grapefruit, cranberry, pomegranate, and aloe vera juices; German chamomile) known to interfere with CYP3A4 or CYP2D6 metabolic enzymes within 1 week prior to Day 1 and during the overall study period.
  • Use of any drugs or substances known to be strong inhibitors of CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.
  • Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic range within 1 week prior to Day 1 or planned to be used during the overall study period.
  • Use of any drugs or substances known to be strong inducers of CYP3A4 or CYP2D6 enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study period.
  • Lactating female patient.
  • Enrolment in a previous study on netupitant (either administered alone or in combination with palonosetron).
  • Marked baseline prolongation of QTc interval (QTcF>460 millisecond [msec]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.

Trial locations and contacts

20 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Tulla Spinelli Head of Clinical Affairs, PharmD, PhD contact

+41919852121

tulla.spinelli@helsinn.com

20 sites in 4 countries

Poland10 sites, 6 recruiting

  • Department of Pediatrics, Oncology and Hematology University Children's Clinical Hospital them. Ludwik Zamenhof in Bialystok

    Bialystok

    Withdrawn

  • Department of Paediatrics, Haematology, Oncology and Rheumatology Voivodship Children's Hospital them. J. Brudziński

    Bydgoszcz, 85-667

    Recruiting

  • Clinic of Pediatrics, Oncology and Hematology University Pediatric Center them M. Konopnicka SP ZOZ Central Clinical Hospital Medical University of Lodz

    Lodz

    Recruiting

  • University Children'S Hospital in Lublin, Department of Pediatric Hematology, Oncology, and Transplantology

    Lublin, 20-093

    Not yet recruiting

  • Clinical Department of Paediatric Oncology and Haematology VOIVODSHIP SPECIALIST CHILDREN'S HOSPITAL them. prof. dr. Stanisław Popowski in Olsztyn

    Olsztyn

    Withdrawn

  • Department of Pediatric Oncology, Hematology and Transplantation Clinical Hospital them. Karol Jonscher Medical University them. Karol Marcinkowski in Poznań

    Poznan

    Recruiting

  • Department of Paediatrics and Paediatric Haemato-Oncology University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University

    Szczecin

    Withdrawn

  • Department of Paediatrics, Oncology and Paediatric Immunology, University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University in Szczecin

    Szczecin

    Withdrawn

  • Department of Oncology and Surgical Oncology for Children and Youth Institute Mother and Child

    Warsaw

    Recruiting

  • Department of Oncology Institute "Monument - Child Health Center"

    Warsaw

    Recruiting

Other trials in Poland

Turkey (Türkiye)5 sites, 5 recruiting

  • Ankara University Faculty of Medicine Children's Hospital, Department of Children Oncology and Hematology

    Ankara, Mamak

    Recruiting

  • Gazi University Gazi Hospital Children Hematology and Oncology

    Ankara

    Recruiting

  • Hacettepe University Hospitals Oncology Hospital 2nd Floor Children Oncology

    Ankara

    Recruiting

  • Istanbul University Istanbul Faculty of Medicine Topkapı

    Istanbul, Faith

    Not yet recruiting

  • Erciyes University Hospitals Kanka Children's Hematology Oncology and Bone Marrow Hospital

    Kayseri, Melikgazi

    Recruiting

Other trials in Turkey (Türkiye)

Romania3 sites, 3 recruiting

  • Fundeni Clinical Institute, Pediatric Hematology and BMT

    Bucharest

    Recruiting

  • Oncology Institute "Prof. Dr. Al. Trestioreanu", Pediatric Oncology

    Bucharest

    Recruiting

  • Emergency Children's Hospital " Louis Turcanu, Oncology-Haematology and BMP department

    Timișoara

    Recruiting

Other trials in Romania

Greece2 sites, 1 recruiting

  • Aghia Sophia Children's Hospital, Pediatric Hematology/ Oncology Unit (POHemU)

    Athens

    Recruiting

  • "AHEPA" University General Hospital of Thessaloniki, 2nd Department of Pediatrics

    Thessaloniki

    Withdrawn

Other trials in Greece

About this study

Official title: 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)

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

Read the 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.

Being tested
IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion, Reference Treatment: IV fosaprepitant infusion
Keywords
Prevention of chemotherapy-induced nausea and vomiting, highly emetogenic chemotherapy, HEC, IV NEPA, CINV
Medical subject headings
Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IV NEPA (fosnetupitant/palonosetron)Drug

    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).

  • Reference Treatment: IV ondansetron infusionDrug

    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)

  • Reference Treatment: IV fosaprepitant infusionDrug

    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)
Study groups in NCT06904235
Study groupRoleWhat they receive
IV NEPAExperimentalThe Test Treatment (IV NEPA) is planned to be administered in Cohort 1 and Cohort 2. IV NEPA Dosing Schedule * Cohort 1 (single-day HEC): Single 30-min infusion on Day 1, before start of chemotherapy. * Cohort 2 (multi-day HEC): Single 30-min infusion on Days 1, 3, and 5 (administration on Day 5 depending on the patient's multi day HEC scheme), before start of chemotherapy or in the morning if no chemotherapy is administered on the same day.
Receives: Drug: IV NEPA (fosnetupitant/palonosetron)
Reference TreatmentActive comparatorThe Reference Treatment is planned to be administered in Cohort 1 only. The Reference Treatment includes fosaprepitant powder for solution for IV infusion and ondansetron liquid solution for IV infusion.
Receives: Drug: Reference Treatment: IV ondansetron infusion; Drug: Reference Treatment: IV fosaprepitant infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COHORT 1 Neptupitant exposure parameter

    Maximum concentration (Cmax)

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

  2. COHORT 1 Neptupitant exposure

    Area under the plasma concentration-time curve

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

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

    monitoring of AEs following repeated IV NEPA administration

    Measured: Up to 31 days

Secondary outcomes (14)

  1. COHORT 1: To assess the PK profile of netupitant.

    Cmax of netupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  2. COHORT 1: To assess the PK profile of fosnetupitant.

    Cmax of fosnetupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  3. COHORT 1: To assess the PK profile palonosetron.

    Cmax of palonosetron

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  4. COHORT 1: To assess the PK profile of netupitant

    AUC0-48 of netupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 48 hours

  5. COHORT 1: To assess the PK profile of fosnetupitant.

    AUC0-48 of fosnetupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 48 hours

  6. COHORT 1: To assess the PK profile palonosetron.

    AUC0-48 of palonosetron

    Measured: From Time zero ( start of IV NEPA infusion) until 48 hours

  7. COHORT 1: To assess the PK profile of netupitant

    t1/2 of netupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  8. COHORT 1: To assess the PK profile of palonosetron.

    t1/2 of palonosetron

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  9. COHORT 1 and 2: To assess the population PK profile of fosnetupitant.

    Clearance (CL) of fosnetupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  10. COHORT 1 and 2: To assess the population PK profile of palonosetron.

    CL of palonosetron

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  11. COHORT 1 and 2: To assess the population PK profile of netupitant.

    CL/F of netupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  12. COHORT 1 and 2: To assess the population PK profile of fosnetupitant

    Volume of compartments (V) for fosnetupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  13. COHORT 1 and 2: To assess the population PK profile of palonosetron.

    V for palonosetron

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

  14. COHORT 1 and 2: To assess the population PK profile of netupitant.

    V/F for netupitant

    Measured: From Time zero ( start of IV NEPA infusion) until 168 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start7 Jul 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
* Cohort 1: Single-day HEC and single-dose administration of Test Treatment (IV NEPA) or administration of Reference Treatment (IV fosaprepitant + IV ondansetron) on Day 1. Due to fosaprepitant and ondansetron not being indicated in patients younger than 6 months of age and due to fosaprepitant not being indicated in patients with body weight \<6 kg, in Cohort 1, patients aged \<6 months will exclusively receive the Test Treatment. Patients aged ≥6 months and weighing at least 6 kg will be randomly allocated to either Test Treatment or Reference Treatment. * Cohort 2: Multi-day HEC and repeated-dose administration of Test Treatment (IV NEPA), with the first administration on Day 1. All patients will receive the Test Treatment
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904235
Sponsor's protocol ID
NEPA-22-01
Other IDs
2024-514321-39
Status last verified
Sep 2026
First submitted
16 Dec 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Only global trial data will be shared, not a single patient

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion and Reference Treatment: IV fosaprepitant infusion in people with Nausea and Vomiting Chemotherapy-Induced and Nausea Post Chemotherapy, run by Helsinn Healthcare SA at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Poland, Turkey (Türkiye), Romania, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tulla Spinelli Head of Clinical Affairs, PharmD, PhD (+41919852121, tulla.spinelli@helsinn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COHORT 1 Neptupitant exposure parameter (time frame: From time zero ( start of IV NEPA infusion) to maximum 168 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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