Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

502

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions
Chemotherapy-Induced Nausea and Vomiting
Interventions
DRUG

Palonosetron

Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg

DRUG

Palonosetron

Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg

DRUG

Ondansetron

Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg

DRUG

Placebo to Ondansetron

DRUG

Placebo to Ondansetron

DRUG

Placebo to Palonosetron

Trial Locations (67)

27

Clinica Anglo Americana - Centro de Investigacion Oncologica CAA, San Isidro Lima

34

Instituto Nacional de Enfermedades Neoplásicas, Lima

1090

Children's Cancer Research Institute, Vienna

Medical University of Vienna, Vienna

1527

Specialised Hospital for Active Treatment of Oncohematological Diseases in Children, Sofia

1684

"Hospital Nacional Prof. Dr. Alejandro Posadas", El Palomar

4002

Pediatrics and Genetic Medicine Clinic, Plovdiv

9010

"Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment Sveta Marina", Varna

10595

Department of Pediatrics, Valhalla

11000

Department for hematology and oncology, Belgrade

13210

Upstate Medical University, Syracuse

13419

Tallin Children's Hospital, Tallinn

18000

Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology, Niš

19803

A. I. duPont Hospital for Children, Wilmington

29425

Medical University of South Carolina, Charleston

31404

Backus Children's Hospital at University Pediatrics, Savannah

32207

Nemours Children's Clinic, Jacksonville

32504

Nemours Children's Clinic, Pensacola

32806

Nemours Children's Clinic-Orlando, Orlando

34295

Hopital Arnaud de Villenueve, Montpellier

37044

CHRU de Tours - Centre de Pediatrie Gatien de Clocheville, Tours

40536

University of Kentucky - Chandler Medical Center, Lexington

43205

Nationwide Children's Hospital, Columbus

50924

University Hospital of Cologne, Cologne

51014

Tartu University Hospital, Hematology - Oncology Clinic, Tartu

59037

CHRU de Lille - Hopital d'Hematologie Pediatrique, Lille

61051

Public Healthcare Institution: Regional Children's Clinical Hospital #1, Kharkiv

72202

Arkansas Children's Hospital, Little Rock

76104

Cook Children's Medical Center, Fort Worth

79106

University Medical Center Freiburg, Freiburg im Breisgau

80045

The Children's Hospital, Aurora

83045

State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery, Donetsk

83052

Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital, Donetsk

91010

City of Hope National Medical Center, Duarte

115478

Russian Oncology Research Center, Moscow

119049

Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital, Moscow

197022

St. Petersburg State Medical University, Saint Petersburg

197110

State Clinical Hospital, Saint Petersburg

350007

Pediatric Regional Clinical Hospital, Krasnodar

400015

"Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca Pediatric Department", Cluj-Napoca

454076

Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department, Chelyabinsk

620149

Regional Pediatric Clinical Hospital #1, Yekaterinburg

644013

Omsk Regional Clinical Oncology Center, Omsk

700309

Sf. Maria - Chidren's Emergency Clinical Hospital, Iași

750053

Hospital Dr Luis Calvo Mackenna, Santiago

7520378

Clinica Santa Maria SA, Santiago

8330024

Hospital Clinico UC, Santiago

8431657

Clinica Davila, Santiago

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

C1431FWO

CEMIC, Buenos Aires

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

625 00

University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology, Brno

708 52

University Hospital in Ostrava, Clinic of Pediatric, Ostrava

304 60

University Hospital in Pilsen, Plzen-Lochotin

150 06

University Hospital Motol, Department of Paediatric Heamatology and Oncology, Prague

H-1094

Semmelweis University, 2nd Department of Pediatrics, Budapest

H-6720

University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics, Szeged

Lima 41

Oncosalud SAC RCI 300, Lima

85-094

Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

91-378

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital, Lodz

20-093

Dzieciecy Szpital Kliniczny, Lublin

04-730

Institut Pomnik - The Children Memorial Health Institute, Department of Oncology, Warsaw

50-368

Samodzielny Publiczny Szpital, Wroclaw

022328

Fundeni Clinical Institute, Pediatrics Clinic, Bucharest

022338

"Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Pediatric Oncology Department", Bucharest

03022

National Institute of Cancer, Kyiv

Sponsors
All Listed Sponsors
lead

Helsinn Healthcare SA

INDUSTRY