502
Participants
Start Date
September 30, 2011
Primary Completion Date
October 31, 2012
Study Completion Date
November 30, 2012
Palonosetron
Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Palonosetron
Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Ondansetron
Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Ondansetron
Placebo to Ondansetron
Placebo to Palonosetron
Clinica Anglo Americana - Centro de Investigacion Oncologica CAA, San Isidro Lima
Instituto Nacional de Enfermedades Neoplásicas, Lima
Children's Cancer Research Institute, Vienna
Medical University of Vienna, Vienna
Specialised Hospital for Active Treatment of Oncohematological Diseases in Children, Sofia
"Hospital Nacional Prof. Dr. Alejandro Posadas", El Palomar
Pediatrics and Genetic Medicine Clinic, Plovdiv
"Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment Sveta Marina", Varna
Department of Pediatrics, Valhalla
Department for hematology and oncology, Belgrade
Upstate Medical University, Syracuse
Tallin Children's Hospital, Tallinn
Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology, Niš
A. I. duPont Hospital for Children, Wilmington
Medical University of South Carolina, Charleston
Backus Children's Hospital at University Pediatrics, Savannah
Nemours Children's Clinic, Jacksonville
Nemours Children's Clinic, Pensacola
Nemours Children's Clinic-Orlando, Orlando
Hopital Arnaud de Villenueve, Montpellier
CHRU de Tours - Centre de Pediatrie Gatien de Clocheville, Tours
University of Kentucky - Chandler Medical Center, Lexington
Nationwide Children's Hospital, Columbus
University Hospital of Cologne, Cologne
Tartu University Hospital, Hematology - Oncology Clinic, Tartu
CHRU de Lille - Hopital d'Hematologie Pediatrique, Lille
Public Healthcare Institution: Regional Children's Clinical Hospital #1, Kharkiv
Arkansas Children's Hospital, Little Rock
Cook Children's Medical Center, Fort Worth
University Medical Center Freiburg, Freiburg im Breisgau
The Children's Hospital, Aurora
State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery, Donetsk
Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital, Donetsk
City of Hope National Medical Center, Duarte
Russian Oncology Research Center, Moscow
Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital, Moscow
St. Petersburg State Medical University, Saint Petersburg
State Clinical Hospital, Saint Petersburg
Pediatric Regional Clinical Hospital, Krasnodar
"Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca Pediatric Department", Cluj-Napoca
Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department, Chelyabinsk
Regional Pediatric Clinical Hospital #1, Yekaterinburg
Omsk Regional Clinical Oncology Center, Omsk
Sf. Maria - Chidren's Emergency Clinical Hospital, Iași
Hospital Dr Luis Calvo Mackenna, Santiago
Clinica Santa Maria SA, Santiago
Hospital Clinico UC, Santiago
Clinica Davila, Santiago
Hospital Italiano de Buenos Aires, Buenos Aires
CEMIC, Buenos Aires
Hospital Privado Centro Medico de Cordoba, Córdoba
University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology, Brno
University Hospital in Ostrava, Clinic of Pediatric, Ostrava
University Hospital in Pilsen, Plzen-Lochotin
University Hospital Motol, Department of Paediatric Heamatology and Oncology, Prague
Semmelweis University, 2nd Department of Pediatrics, Budapest
University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics, Szeged
Oncosalud SAC RCI 300, Lima
Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology, Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital, Lodz
Dzieciecy Szpital Kliniczny, Lublin
Institut Pomnik - The Children Memorial Health Institute, Department of Oncology, Warsaw
Samodzielny Publiczny Szpital, Wroclaw
Fundeni Clinical Institute, Pediatrics Clinic, Bucharest
"Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Pediatric Oncology Department", Bucharest
National Institute of Cancer, Kyiv
Lead Sponsor
Helsinn Healthcare SA
INDUSTRY