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    Summary
    EudraCT Number:2020-003730-20
    Sponsor's Protocol Code Number:NEPA-15-31
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-003730-20
    A.3Full title of the trial
    A multicenter, multinational, randomized, double-blind, pharmacokinetic and
    pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered
    concomitantly with oral palonosetron in pediatric cancer patients for the prevention
    of nausea and vomiting associated with emetogenic chemotherapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    dose-finding study of oral netupitant administered
    concomitantly with oral palonosetron in pediatric cancer patients
    A.4.1Sponsor's protocol code numberNEPA-15-31
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03204279
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/272/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHelsinn Healthcare SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinn Healthcare SA
    B.5.2Functional name of contact pointPaolo Villasanta
    B.5.3 Address:
    B.5.3.1Street AddressVia di Pian Scairolo
    B.5.3.2Town/ citylugano
    B.5.3.3Post code6912
    B.5.3.4CountrySwitzerland
    B.5.6E-mailpaolo.villasanta@helsinn.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namenetupitant
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name aloxi
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Healthcare, SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepalonosetron
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    nausea and vomiting associating with emetogenic chemotherapy
    E.1.1.1Medical condition in easily understood language
    nausea and vomiting
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047700
    E.1.2Term Vomiting
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028813
    E.1.2Term Nausea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PK/PD correlation between netupitant exposure and antiemetic efficacy after a single oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer patients receiving chemotherapy
    E.2.2Secondary objectives of the trial
    to assess the safety and tolerability after single oral administration of netupitant given concomitantly with a single oral administration of palonosetron
    to evaluate the pk profile of oral palonosetron at the fixed dose of 20microg/kg in pediatric patients with the concomitant administration of netupitant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female pediatric cancer patients from birth up to <18 years, who were scheduled to receive HEC or MEC to be administered as single-day chemotherapy on Day 1 only or for multiple days.
    E.4Principal exclusion criteria
    Known history of allergy to any component or other contraindications to any NK1 or 5-HT3 receptor antagonists; Patient was suffering from ongoing vomiting from any organic etiology (including a history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus; a symptomatic central nervous system tumor causing nausea and/or vomiting) or hydrocephalus; 8. Patient who received any drug with potential antiemetic effect within 24 hours prior to the start of reference chemotherapy, 9. Patient who received palonosetron within 1 week prior to administration of study drug; 17. Patient with clinically relevant Grade 3 or 4 non-hematological abnormal laboratory values; Enrollment in a previous study with netupitant (either alone or in combination with palonosetron); Marked baseline prolongation of corrected QT (QTc) interval [QTc interval by Bazett’s formula [QTcB] or QTc interval by Fridericia’s formula [QTcF] >460 msec] at screening.
    E.5 End points
    E.5.1Primary end point(s)
    The PK/PD relationship between netupitant exposure (area under the plasma concentration-time curve [AUC] and maximum plasma concentration [Cmax]) and antiemetic efficacy in the delayed phase after a single oral netupitant administration given concomitantly with oral palonosetron in pediatric cancer patients receiving HEC or MEC treatments. The efficacy parameter used in the primary PK/PD analysis was the proportion of patients with CR (i.e., no emetic episodes and no rescue medication) during the delayed phase (>24 to 120 hours after the start of chemotherapy on Day 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients > 5 years from 2 to 8 h, from 24 to 48h, from 72 to 96h and from 120 to 168h
    Patients <5 years from 2 to 8 h, from 24 to 48h, and from 120 to 168h
    E.5.2Secondary end point(s)
    • Pharmacokinetic endpoint:
    o AUC, Cmax, time of the maximum plasma concentration (tmax), and half-life (t1/2) of netupitant, netupitant metabolites M1, M2, M3, and palonosetron.
    • Efficacy endpoints:
    o Proportion of patients with CR, (i.e., no emetic episodes and no rescue medication), during the delayed (>24 to 120 hours), acute (0 to 24 hours), and overall phases (0 to 120 hours) after start of chemotherapy administration on Day 1.
    o Proportion of patients with no emetic episodes during the delayed (>24 to 120 hours), acute (0 to 24 hours), and overall phases (0 to 120 hours) after start of chemotherapy administration on Day 1.
    o Proportion of patients with no rescue medication during the delayed (>24 to 120 hours), acute (0 to 24 hours), and overall phases (0 to 120 hours) after start of chemotherapy administration on Day 1.
    • Safety endpoints:
    o Safety was assessed by means of adverse events (AEs), clinical laboratory tests (serum chemistry, hematology, and urinalysis), physical examinations, vital signs, and 12-lead electrocardiograms (ECGs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients > 5 years from 2 to 8 h, from 24 to 48h, from 72 to 96h and from 120 to 168h
    Patients <5 years from 2 to 8 h, from 24 to 48h, and from 120 to 168h
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Russian Federation
    Serbia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    16 July 2019
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 66
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 28
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Russian Federation
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