95
Participants
Start Date
July 7, 2025
Primary Completion Date
October 31, 2027
Study Completion Date
December 31, 2027
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)."
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)"
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)"
NOT_YET_RECRUITING
Aghia Sophia Children's Hospital, Pediatric Hematology/ Oncology Unit (POHemU), Athens
NOT_YET_RECRUITING
"AHEPA University General Hospital of Thessaloniki, 2nd Department of Pediatrics", Thessaloniki
RECRUITING
Department of Pediatrics, Oncology and Hematology University Children's Clinical Hospital them. Ludwik Zamenhof in Bialystok, Bialystok
NOT_YET_RECRUITING
Clinic of Pediatrics, Oncology and Hematology University Pediatric Center them M. Konopnicka SP ZOZ Central Clinical Hospital Medical University of Lodz, Lodz
NOT_YET_RECRUITING
Clinical Department of Paediatric Oncology and Haematology VOIVODSHIP SPECIALIST CHILDREN'S HOSPITAL them. prof. dr. Stanisław Popowski in Olsztyn, Olsztyn
RECRUITING
Department of Pediatric Oncology, Hematology and Transplantation Clinical Hospital them. Karol Jonscher Medical University them. Karol Marcinkowski in Poznań, Poznan
NOT_YET_RECRUITING
Department of Paediatrics and Paediatric Haemato-Oncology University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University, Szczecin
RECRUITING
Department of Paediatrics, Oncology and Paediatric Immunology, University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University in Szczecin, Szczecin
RECRUITING
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
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
NOT_YET_RECRUITING
Istanbul University Istanbul Faculty of Medicine Topkapı, Istanbul
NOT_YET_RECRUITING
Ankara University Faculty of Medicine Children's Hospital, Department of Children Oncology and Hematology, Ankara
NOT_YET_RECRUITING
Erciyes University Hospitals Kanka Children's Hematology Oncology and Bone Marrow Hospital, Kayseri
NOT_YET_RECRUITING
Gazi University Gazi Hospital Children Hematology and Oncology, Ankara
NOT_YET_RECRUITING
Hacettepe University Hospitals Oncology Hospital 2nd Floor Children Oncology, Ankara
Lead Sponsor
Helsinn Healthcare SA
INDUSTRY