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

Information source: Helsinn Healthcare SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-Induced Nausea and Vomiting

Intervention: Palonosetron (Drug); Palonosetron (Drug); Ondansetron (Drug); Placebo to Ondansetron (Drug); Placebo to Ondansetron (Drug); Placebo to Palonosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Helsinn Healthcare SA


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1

Secondary outcome: Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1

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.


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

Locations and Contacts

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

Additional Information

Starting date: September 2011
Last updated: August 4, 2014

Page last updated: August 23, 2015

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