Actively Recruiting
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Led by Helsinn Healthcare SA · Updated on 2026-03-31
95
Participants Needed
20
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parent or legal guardian and assent as required
- Male or female patient from newborn (0 months) up to under 18 years of age at enrollment
- Cohort 1: Patients under 6 months must weigh at least 4 kg; patients 6 months or older must weigh at least 6 kg
- Cohort 2: Patients must weigh at least 4 kg
- Predicted life expectancy of at least 3 months as assessed by the investigator
- Diagnosed malignant disease confirmed by histology, cytology, or imaging
- Cohort 1: Scheduled to receive at least one cycle of single-day highly emetogenic chemotherapy (HEC)
- Cohort 2: Scheduled to receive at least one cycle of multi-day HEC
- For patients aged 10 years or older: Eastern Cooperative Oncology Group performance status of 0 to 2
- For known hepatic impairment: serum ALT and AST ≤2.5 times upper limit of normal, total bilirubin ≤1.5 times upper limit of normal, and safe in investigator's opinion
- For known renal impairment: estimated glomerular filtration rate ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for children under 3 months), and safe in investigator's opinion
- History or predisposition to cardiac abnormalities considered safe by investigator
- Non-clinically significant or stable abnormal laboratory values deemed safe by investigator
- Female patients either not yet menstruating or with negative pregnancy tests at screening and Day 1
- Fertile male or female patients must use reliable contraception and be counseled on pregnancy prevention
You will not qualify if you...
- Expected non-compliance with study procedures by patient or parent/guardian
- Received or scheduled to receive certain types of radiation therapy within 1 week before or shortly after chemotherapy start
- Known allergy or contraindication to study treatments or related drug classes
- Active infection
- Any condition posing undue risk for study treatment as judged by investigator
- Uncontrolled medical conditions such as uncontrolled insulin-dependent diabetes
- Ongoing vomiting from organic causes or hydrocephalus
- Vomiting, retching, or nausea within 24 hours prior to study treatment, excluding functional vomiting in infants under 3 months
- Use of antiemetic or related medications within 24 hours before study treatment
- Palonosetron use within 1 week before study treatment
- Systemic corticosteroid therapy above specified dosages, except permitted dexamethasone use with dose adjustment
- Recent or planned use of investigational drugs within specified timeframes
- Intake or planned use of substances affecting CYP3A4 or CYP2D6 enzymes within specified timeframes
- Lactating female patients
- Previous participation in netupitant studies
- Significant baseline QT interval prolongation (QTcF >460 ms) unless deemed safe by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Aghia Sophia Children's Hospital, Pediatric Hematology/ Oncology Unit (POHemU)
Athens, Greece
Actively Recruiting
2
"AHEPA" University General Hospital of Thessaloniki, 2nd Department of Pediatrics
Thessaloniki, Greece
Actively Recruiting
3
Department of Pediatrics, Oncology and Hematology University Children's Clinical Hospital them. Ludwik Zamenhof in Bialystok
Bialystok, Poland
Withdrawn
4
Department of Paediatrics, Haematology, Oncology and Rheumatology Voivodship Children's Hospital them. J. Brudziński
Bydgoszcz, Poland, 85-667
Not Yet Recruiting
5
Clinic of Pediatrics, Oncology and Hematology University Pediatric Center them M. Konopnicka SP ZOZ Central Clinical Hospital Medical University of Lodz
Lodz, Poland
Actively Recruiting
6
University Children'S Hospital in Lublin, Department of Pediatric Hematology, Oncology, and Transplantology
Lublin, Poland, 20-093
Not Yet Recruiting
7
Clinical Department of Paediatric Oncology and Haematology VOIVODSHIP SPECIALIST CHILDREN'S HOSPITAL them. prof. dr. Stanisław Popowski in Olsztyn
Olsztyn, Poland
Withdrawn
8
Department of Pediatric Oncology, Hematology and Transplantation Clinical Hospital them. Karol Jonscher Medical University them. Karol Marcinkowski in Poznań
Poznan, Poland
Actively Recruiting
9
Department of Paediatrics and Paediatric Haemato-Oncology University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University
Szczecin, Poland
Withdrawn
10
Department of Paediatrics, Oncology and Paediatric Immunology, University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University in Szczecin
Szczecin, Poland
Actively Recruiting
11
Department of Oncology and Surgical Oncology for Children and Youth Institute Mother and Child
Warsaw, Poland
Actively Recruiting
12
Department of Oncology Institute "Monument - Child Health Center"
Warsaw, Poland
Actively Recruiting
13
Fundeni Clinical Institute, Pediatric Hematology and BMT
Bucharest, Romania
Actively Recruiting
14
Oncology Institute "Prof. Dr. Al. Trestioreanu", Pediatric Oncology
Bucharest, Romania
Actively Recruiting
15
Emergency Children's Hospital " Louis Turcanu, Oncology-Haematology and BMP department
Timișoara, Romania
Actively Recruiting
16
Istanbul University Istanbul Faculty of Medicine Topkapı
Istanbul, Faith, Turkey (Türkiye)
Not Yet Recruiting
17
Ankara University Faculty of Medicine Children's Hospital, Department of Children Oncology and Hematology
Ankara, Mamak, Turkey (Türkiye)
Actively Recruiting
18
Erciyes University Hospitals Kanka Children's Hematology Oncology and Bone Marrow Hospital
Kayseri, Melikgazi, Turkey (Türkiye)
Actively Recruiting
19
Gazi University Gazi Hospital Children Hematology and Oncology
Ankara, Turkey (Türkiye)
Actively Recruiting
20
Hacettepe University Hospitals Oncology Hospital 2nd Floor Children Oncology
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
T
Tulla Spinelli Head of Clinical Affairs, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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