The primary objective is to evaluate the efficacy of two different doses of IV palonosetron
in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients
through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles.
The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in
pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of
pediatric CINV patients.
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
Inclusion Criteria:
- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3. 2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged ≥ 10 years to <17 years: ECOG PS ≤ 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
Exclusion Criteria:
- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to
the administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e. g. aprepitant)
- 5-HT3 antagonists (e. g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e. g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e. g., droperidol, haloperidol);
- Benzamides (e. g., metoclopramide, alizapride);
- Corticosteroids (e. g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of ≤ 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged ≤ 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any 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 is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
CEMIC, Buenos Aires C1431FWO, Argentina
Hospital Italiano de Buenos Aires, Buenos Aires C1181ACH, Argentina
Hospital Privado Centro Medico de Cordoba, Cordoba X5016KEH, Argentina
Hospital Nacional "Prof. Dr. Alejandro Posadas", El Palomar 1684, Argentina
Children's Cancer Research Institute, Wien 1090, Austria
Medical University of Vienna, Wien 1090, Austria
Pediatrics and Genetic Medicine Clinic, Plovdiv 4002, Bulgaria
Specialised Hospital for Active Treatment of Oncohematological Diseases in Children, Sofia 1527, Bulgaria
Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment "Sveta Marina", Varna 9010, Bulgaria
Clinica Davila, Santiago 8431657, Chile
Clinica Santa Maria SA, Santiago 7520378, Chile
Hospital Clinico UC, Santiago 8330024, Chile
Hospital Dr Luis Calvo Mackenna, Santiago 750053, Chile
University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology, Brno 625 00, Czech Republic
University Hospital in Ostrava, Clinic of Pediatric, Ostrava 708 52, Czech Republic
University Hospital in Pilsen, Plzen-Lochotin 304 60, Czech Republic
University Hospital Motol, Department of Paediatric Heamatology and Oncology, Praha 5 150 06, Czech Republic
Tallin Children's Hospital, Tallinn 13419, Estonia
Tartu University Hospital, Hematology - Oncology Clinic, Tartu 51014, Estonia
CHRU de Lille - Hopital d'Hematologie Pediatrique, Lille Cedex 59037, France
Hopital Arnaud de Villenueve, Montpellier 34295, France
CHRU de Tours - Centre de Pediatrie Gatien de Clocheville, Tours Cedex 09 37044, France
University Hospital of Cologne, Cologne 50924, Germany
University Medical Center Freiburg, Freiburg 79106, Germany
Semmelweis University, 2nd Department of Pediatrics, Budapest H-1094, Hungary
University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics, Szeged H-6720, Hungary
Instituto Nacional de Enfermedades Neoplásicas, Lima 34, Peru
Oncosalud SAC RCI 300, Lima Lima 41, Peru
Clinica Anglo Americana - Centro de Investigacion Oncologica CAA, San Isidro Lima 27, Peru
Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology, Bydgoszcz 85-094, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk 80-952, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital, Lodz 91-378, Poland
Dzieciecy Szpital Kliniczny, Lublin 20-093, Poland
Institut Pomnik - The Children Memorial Health Institute, Department of Oncology, Warsaw 04-730, Poland
Samodzielny Publiczny Szpital, Wroclaw 50-368, Poland
"Prof. Dr. Alexandru Trestioreanu" Institute of Oncology, Pediatric Oncology Department, Bucharest 022338, Romania
Fundeni Clinical Institute, Pediatrics Clinic, Bucharest 022328, Romania
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca Pediatric Department, Cluj 400015, Romania
Sf. Maria - Chidren's Emergency Clinical Hospital, Iasi 700309, Romania
Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department, Chelyabinsk 454076, Russian Federation
Regional Pediatric Clinical Hospital #1, Ekaterinburg 620149, Russian Federation
Pediatric Regional Clinical Hospital, Krasnodar 350007, Russian Federation
Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital, Moscow 119049, Russian Federation
Russian Oncology Research Center, Moscow 115478, Russian Federation
Omsk Regional Clinical Oncology Center, Omsk 644013, Russian Federation
St. Petersburg State Medical University, St. Petersburg 197022, Russian Federation
State Clinical Hospital, St. Petersburg 197110, Russian Federation
Department for hematology and oncology, Belgrade 11000, Serbia
Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology, Nis 18000, Serbia
Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital, Donetsk 83052, Ukraine
State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery, Donetsk 83045, Ukraine
Public Healthcare Institution: Regional Children's Clinical Hospital #1, Kharkiv 61051, Ukraine
National Institute of Cancer, Kyiv 03022, Ukraine
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States
City of Hope National Medical Center, Duarte, California 91010, United States
The Children's Hospital, Aurora, Colorado 80045, United States
A. I. duPont Hospital for Children, Wilmington, Delaware 19803, United States
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Nemours Children's Clinic-Orlando, Orlando, Florida 32806, United States
Nemours Children's Clinic, Pensacola, Florida 32504, United States
Backus Children's Hospital at University Pediatrics, Savannah, Georgia 31404, United States
University of Kentucky - Chandler Medical Center, Lexington, Kentucky 40536, United States
Upstate Medical University, Syracuse, New York 13210, United States
Department of Pediatrics, Valhalla, New York 10595, United States
Nationwide Children's Hospital, Columbus, Ohio 43205, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Cook Children's Medical Center, Fort Worth, Texas 76104, United States