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

August 4, 2014 updated by: Helsinn Healthcare SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
502

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Palonosetron
Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Drug: Placebo to Ondansetron
EXPERIMENTAL: Palonosetron 20 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: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1
Time Frame: 0 to 24 hours after T0
Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.
0 to 24 hours after T0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1
Time Frame: from >24 to 120 hours (delayed phase) after T0
Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.
from >24 to 120 hours (delayed phase) after T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinn Healthcare SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PALO-10-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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