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Chemotherapy-Induced Nausea and VomitingPhase 3NCT01442376

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

A Phase 3 study testing Palonosetron and Ondansetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 67 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Chemotherapy-Induced Nausea and Vomiting
What is being tested?
Palonosetron and Ondansetron
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
502 participants
Where
67 sitesin 16 countries
Study dates
Sep 2011to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

67 sites in 16 countries.

67 sites in 16 countries

United States14 sites

  • The Children's Hospital

    Aurora, Colorado, 80045

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • University of Kentucky - Chandler Medical Center

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Nemours Children's Clinic

    Pensacola, Florida, 32504

  • Backus Children's Hospital at University Pediatrics

    Savannah, Georgia, 31404

  • Upstate Medical University

    Syracuse, New York, 13210

  • Department of Pediatrics

    Valhalla, New York, 10595

  • A. I. duPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

Russia8 sites

  • Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department

    Chelyabinsk, 454076

  • Pediatric Regional Clinical Hospital

    Krasnodar, 350007

  • Russian Oncology Research Center

    Moscow, 115478

  • Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital

    Moscow, 119049

  • Omsk Regional Clinical Oncology Center

    Omsk, 644013

  • St. Petersburg State Medical University

    Saint Petersburg, 197022

  • State Clinical Hospital

    Saint Petersburg, 197110

  • Regional Pediatric Clinical Hospital #1

    Yekaterinburg, 620149

Other trials in Russia

Poland6 sites

  • Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology

    Bydgoszcz, 85-094

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital

    Lodz, 91-378

  • Dzieciecy Szpital Kliniczny

    Lublin, 20-093

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

    Warsaw, 04-730

  • Samodzielny Publiczny Szpital

    Wroclaw, 50-368

Other trials in Poland

Argentina4 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • CEMIC

    Buenos Aires, C1431FWO

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Nacional "Prof. Dr. Alejandro Posadas"

    El Palomar, 1684

Other trials in Argentina

Chile4 sites

  • Hospital Dr Luis Calvo Mackenna

    Santiago, 750053

  • Clinica Santa Maria SA

    Santiago, 7520378

  • Hospital Clinico UC

    Santiago, 8330024

  • Clinica Davila

    Santiago, 8431657

Other trials in Chile

Czechia4 sites

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

    Brno, 625 00

  • University Hospital in Ostrava, Clinic of Pediatric

    Ostrava, 708 52

  • University Hospital in Pilsen

    Plzen-Lochotin, 304 60

  • University Hospital Motol, Department of Paediatric Heamatology and Oncology

    Prague, 150 06

Other trials in Czechia

Romania4 sites

  • Fundeni Clinical Institute, Pediatrics Clinic

    Bucharest, 022328

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

    Bucharest, 022338

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

    Cluj-Napoca, 400015

  • Sf. Maria - Chidren's Emergency Clinical Hospital

    Iași, 700309

Other trials in Romania

Ukraine4 sites

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

    Donetsk, 83045

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

    Donetsk, 83052

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

    Kharkiv, 61051

  • National Institute of Cancer

    Kyiv, 03022

Other trials in Ukraine

Bulgaria3 sites

  • Pediatrics and Genetic Medicine Clinic

    Plovdiv, 4002

  • Specialised Hospital for Active Treatment of Oncohematological Diseases in Children

    Sofia, 1527

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

    Varna, 9010

Other trials in Bulgaria

France3 sites

  • CHRU de Lille - Hopital d'Hematologie Pediatrique

    Lille, 59037

  • Hopital Arnaud de Villenueve

    Montpellier, 34295

  • CHRU de Tours - Centre de Pediatrie Gatien de Clocheville

    Tours, 37044

Other trials in France

Peru3 sites

  • Instituto Nacional de Enfermedades Neoplásicas

    Lima, 34

  • Oncosalud SAC RCI 300

    Lima, Lima 41

  • Clinica Anglo Americana - Centro de Investigacion Oncologica CAA

    San Isidro Lima, 27

Other trials in Peru

Austria2 sites

  • Children's Cancer Research Institute

    Vienna, 1090

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Estonia2 sites

  • Tallin Children's Hospital

    Tallinn, 13419

  • Tartu University Hospital, Hematology - Oncology Clinic

    Tartu, 51014

Other trials in Estonia

Germany2 sites

  • University Hospital of Cologne

    Cologne, 50924

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106

Other trials in Germany

Hungary2 sites

  • Semmelweis University, 2nd Department of Pediatrics

    Budapest, H-1094

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

    Szeged, H-6720

Other trials in Hungary

Serbia2 sites

  • Department for hematology and oncology

    Belgrade, 11000

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

    Niš, 18000

Other trials in Serbia

About this study

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

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.

Read the 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.

Being tested
Palonosetron, Ondansetron, Placebo to Ondansetron, Placebo to Palonosetron
Keywords
Prevention of Chemotherapy-Induced Nausea and Vomiting, Palonosetron, Ondansetron, Pediatric
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalonosetronDrug

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

  • PalonosetronDrug

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

  • OndansetronDrug

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

  • Placebo to OndansetronDrug

  • Placebo to OndansetronDrug

  • Placebo to PalonosetronDrug

Study groups in NCT01442376
Study groupRoleWhat they receive
Palonosetron 10 mcg/kgExperimentalPalonosetron and placebo to Ondansetron Intervention: Drug: Palonosetron
Receives: Drug: Palonosetron; Drug: Placebo to Ondansetron
Palonosetron 20 mcg/kgExperimentalPalonosetron and placebo to Ondansetron Intervention: Drug: Palonosetron
Receives: Drug: Palonosetron; Drug: Placebo to Ondansetron
OndansetronActive comparatorOndansetron and placebo to Palonosetron Drug: Comparator: Ondansetron
Receives: Drug: Ondansetron; Drug: Placebo to Palonosetron

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 0 to 24 hours after T0

Secondary outcomes (1)

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

    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.

    Measured: from >24 to 120 hours (delayed phase) after T0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442376
Sponsor's protocol ID
PALO-10-20
Status last verified
Aug 2014
First submitted
21 Sep 2011
Last updated
7 Aug 2014
Data monitoring committee
Yes

Publications

  • Kovacs G, Wachtel AE, Basharova EV, Spinelli T, Nicolas P, Kabickova E. Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. Lancet Oncol. 2016 Mar;17(3):332-344. doi: 10.1016/S1470-2045(15)00520-3. Epub 2016 Jan 19.

    PubMed 26795844

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palonosetron and Ondansetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 67 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Russia, Poland, Argentina, Chile and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1 (time frame: 0 to 24 hours after T0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.

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