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

Recruiting now · Phase 2

Conditions studied: Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy

In brief

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

Key facts

Study ID

NCT06904235

Run by

Helsinn Healthcare SA

People needed

95

Starts

2025-07-07

Expected to finish

2027-12-01

Last updated by the study team

2026-06-01

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• Hacettepe University Hospitals Oncology Hospital 2nd Floor Children Oncology — Ankara, Turkey (Türkiye) (enrolling)
• "AHEPA" University General Hospital of Thessaloniki, 2nd Department of Pediatrics — Thessaloniki, Greece (enrolling)
• Emergency Children's Hospital " Louis Turcanu, Oncology-Haematology and BMP department — Timișoara, Romania (enrolling)
• Ankara University Faculty of Medicine Children's Hospital, Department of Children Oncology and Hematology — Ankara, Mamak, Turkey (Türkiye) (enrolling)
• Erciyes University Hospitals Kanka Children's Hematology Oncology and Bone Marrow Hospital — Kayseri, Melikgazi, Turkey (Türkiye) (enrolling)
• Gazi University Gazi Hospital Children Hematology and Oncology — Ankara, Turkey (Türkiye) (enrolling)
• Aghia Sophia Children's Hospital, Pediatric Hematology/ Oncology Unit (POHemU) — Athens, Greece (enrolling)
• Department of Paediatrics, Haematology, Oncology and Rheumatology Voivodship Children's Hospital them. J. Brudziński — Bydgoszcz, Poland (enrolling)
• Clinic of Pediatrics, Oncology and Hematology University Pediatric Center them M. Konopnicka SP ZOZ Central Clinical Hospital Medical University of Lodz — Lodz, Poland (enrolling)
• Department of Pediatric Oncology, Hematology and Transplantation Clinical Hospital them. Karol Jonscher Medical University them. Karol Marcinkowski in Poznań — Poznan, Poland (enrolling)
• Department of Paediatrics, Oncology and Paediatric Immunology, University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University in Szczecin — Szczecin, Poland (enrolling)
• Department of Oncology and Surgical Oncology for Children and Youth Institute Mother and Child — Warsaw, Poland (enrolling)
• Department of Oncology Institute "Monument - Child Health Center" — Warsaw, Poland (enrolling)
• Fundeni Clinical Institute, Pediatric Hematology and BMT — Bucharest, Romania (enrolling)
• Oncology Institute "Prof. Dr. Al. Trestioreanu", Pediatric Oncology — Bucharest, Romania (enrolling)
• Department of Pediatrics, Oncology and Hematology University Children's Clinical Hospital them. Ludwik Zamenhof in Bialystok — Bialystok, Poland
• Istanbul University Istanbul Faculty of Medicine Topkapı — Istanbul, Faith, Turkey (Türkiye)
• Department of Paediatrics and Paediatric Haemato-Oncology University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University — Szczecin, Poland
• University Children'S Hospital in Lublin, Department of Pediatric Hematology, Oncology, and Transplantology — Lublin, Poland
• Clinical Department of Paediatric Oncology and Haematology VOIVODSHIP SPECIALIST CHILDREN'S HOSPITAL them. prof. dr. Stanisław Popowski in Olsztyn — Olsztyn, Poland

Full record on ClinicalTrials.gov

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