Trial record 1 of 1 for:    PALO-10-20
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Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01442376
First received: September 21, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Drug: Palonosetron
Drug: Ondansetron
Drug: Placebo to Ondansetron
Drug: Placebo to Palonosetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • Change in proportion of patients with Complete Response (CR) defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 during first cycle [ Time Frame: 0 to 24 hours after T0 ] [ Designated as safety issue: No ]
    Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy


Secondary Outcome Measures:
  • Proportion of patients with CR in delayed and overall phases. [ Time Frame: from >24 to 120 hours (delayed phase) after T0; 0 to 120 hours (overall period) after T0; 0 to 24 hours after T0 (acute phase) ] [ Designated as safety issue: No ]
    For each period during first cycle: Proportion of patients without vomiting, without emetic episodes, without antiemetic rescue medication and without nausea (patients aged ≥ 6 years)


Enrollment: 494
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonosetron 10 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Drug: Palonosetron
Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Drug: Placebo to Ondansetron
Experimental: Palonosetron 20 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Drug: Palonosetron
Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Drug: Placebo to Ondansetron
Active Comparator: Ondansetron

Ondansetron and placebo to Palonosetron

Drug:

Comparator: Ondansetron

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 Palonosetron

Detailed Description:

For neonates (<28 days, full term) an open-label sub-study will be conducted to assess exposure and tolerability in this age group with escalating doses of palonosetron, starting with 3 mcg/kg to the first three or more neonates included in the study. If this dose is shown to be safe and well tolerated then the following three neonates will be treated with a dose of 10 mcg/kg. If also this dose is safe and well tolerated, then the following three neonates will be treated with a dose of 20 mcg/kg. If this last dose is also shown to be safe and well tolerated, then all the following neonates will be randomized to the main study.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442376

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Delaware
A. I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic
Pensacola, Florida, United States, 32504
United States, Georgia
Backus Children's Hospital at University Pediatrics
Savannah, Georgia, United States, 31404
United States, Kentucky
University of Kentucky - Chandler Medical Center
Lexington, Kentucky, United States, 40536
United States, New York
Upstate Medical University
Syracuse, New York, United States, 13210
Department of Pediatrics
Valhalla, New York, United States, 10595
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
CEMIC
Buenos Aires, Argentina, C1431FWO
Hospital Privado Centro Medico de Cordoba
Cordoba, Argentina, X5016KEH
Hospital Nacional "Prof. Dr. Alejandro Posadas"
El Palomar, Argentina, 1684
Austria
Children's Cancer Research Institute
Wien, Austria, 1090
Medical University of Vienna
Wien, Austria, 1090
Bulgaria
Pediatrics and Genetic Medicine Clinic
Plovdiv, Bulgaria, 4002
Specialised Hospital for Active Treatment of Oncohematological Diseases in Children
Sofia, Bulgaria, 1527
Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment "Sveta Marina"
Varna, Bulgaria, 9010
Chile
Hospital Dr Luis Calvo Mackenna
Santiago, Chile, 750053
Clinica Davila
Santiago, Chile, 8431657
Clinica Santa Maria SA
Santiago, Chile, 7520378
Hospital Clinico UC
Santiago, Chile, 8330024
Czech Republic
University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology
Brno, Czech Republic, 625 00
University Hospital in Ostrava, Clinic of Pediatric
Ostrava, Czech Republic, 708 52
University Hospital in Pilsen
Plzen-Lochotin, Czech Republic, 304 60
University Hospital Motol, Department of Paediatric Heamatology and Oncology
Praha 5, Czech Republic, 150 06
Estonia
Tallin Children's Hospital
Tallinn, Estonia, 13419
Tartu University Hospital, Hematology - Oncology Clinic
Tartu, Estonia, 51014
France
CHRU de Lille - Hopital d'Hematologie Pediatrique
Lille Cedex, France, 59037
Hopital Arnaud de Villenueve
Montpellier, France, 34295
CHRU de Tours - Centre de Pediatrie Gatien de Clocheville
Tours Cedex 09, France, 37044
Germany
University Hospital of Cologne
Cologne, Germany, 50924
University Medical Center Freiburg
Freiburg, Germany, 79106
Hungary
Semmelweis University, 2nd Department of Pediatrics
Budapest, Hungary, H-1094
University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics
Szeged, Hungary, H-6720
Peru
Oncosalud SAC RCI 300
Lima, Peru, Lima 41
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru, 34
Clinica Anglo Americana - Centro de Investigacion Oncologica CAA
San Isidro Lima, Peru, 27
Poland
Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology
Bydgoszcz, Poland, 85-094
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital
Lodz, Poland, 91-378
Dzieciecy Szpital Kliniczny
Lublin, Poland, 20-093
Institut Pomnik - The Children Memorial Health Institute, Department of Oncology
Warsaw, Poland, 04-730
Samodzielny Publiczny Szpital
Wroclaw, Poland, 50-368
Romania
"Prof. Dr. Alexandru Trestioreanu" Institute of Oncology, Pediatric Oncology Department
Bucharest, Romania, 022338
Fundeni Clinical Institute, Pediatrics Clinic
Bucharest, Romania, 022328
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca Pediatric Department
Cluj, Romania, 400015
Sf. Maria - Chidren's Emergency Clinical Hospital
Iasi, Romania, 700309
Russian Federation
Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department
Chelyabinsk, Russian Federation, 454076
Regional Pediatric Clinical Hospital #1
Ekaterinburg, Russian Federation, 620149
Pediatric Regional Clinical Hospital
Krasnodar, Russian Federation, 350007
Russian Oncology Research Center
Moscow, Russian Federation, 115478
Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital
Moscow, Russian Federation, 119049
Omsk Regional Clinical Oncology Center
Omsk, Russian Federation, 644013
State Clinical Hospital
St. Petersburg, Russian Federation, 197110
St. Petersburg State Medical University
St. Petersburg, Russian Federation, 197022
Serbia
Department for hematology and oncology
Belgrade, Serbia, 11000
Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology
Nis, Serbia, 18000
Ukraine
State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery
Donetsk, Ukraine, 83045
Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital
Donetsk, Ukraine, 83052
Public Healthcare Institution: Regional Children's Clinical Hospital #1
Kharkiv, Ukraine, 61051
National Institute of Cancer
Kyiv, Ukraine, 03022
Sponsors and Collaborators
Helsinn Healthcare SA
  More Information

No publications provided

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01442376     History of Changes
Other Study ID Numbers: PALO-10-20
Study First Received: September 21, 2011
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care
Chile: Instituto de Salud Publica de Chile
Romania: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Ukraine: Ministry of Health
Germany: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Peru: Instituto Nacional de Salud
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Helsinn Healthcare SA:
Prevention of Chemotherapy-Induced Nausea and Vomiting
Palonosetron
Ondansetron
Pediatric

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 20, 2014