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    Summary
    EudraCT Number:2018-000662-11
    Sponsor's Protocol Code Number:ONO-7436-03
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-02-16
    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 number2018-000662-11
    A.3Full title of the trial
    ONO-7436 Phase III Study – A multicenter, open-label, uncontrolled study for the prevention of chemotherapy-induced nausea and vomiting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, open-label, uncontrolled study for the prevention of chemotherapy-induced nausea and vomiting
    A.4.1Sponsor's protocol code numberONO-7436-03
    A.5.4Other Identifiers
    Name:Merck Sharp & Dohme Corp., Inc.Number:MK-0869-206
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOno Pharmaceutical Co., Ltd.
    B.1.3.4CountryJapan
    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 supportOno Pharmaceutical Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOno Pharmaceutical Co., Ltd.
    B.5.2Functional name of contact pointHiroyuki Takata
    B.5.3 Address:
    B.5.3.1Street Address8-2, Kyutaromachi 1-chome, Chuo-ku
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code541-8564
    B.5.3.4CountryJapan
    B.5.4Telephone number066263-3904
    B.5.5Fax number066263-2970
    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 Yes
    D.2.1.1.1Trade name EMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPREPITANT
    D.3.9.3Other descriptive nameAPREPITANT, ONO-7436
    D.3.9.4EV Substance CodeSUB20017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 EMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPREPITANT
    D.3.9.3Other descriptive nameAPREPITANT, ONO-7436
    D.3.9.4EV Substance CodeSUB20017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Chemotherapy-induced nausea and vomiting (CINV) associated with emetogenic chemotherapy
    E.1.1.1Medical condition in easily understood language
    Nausea and vomiting caused by chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036899
    E.1.2Term Prophylaxis against chemotherapy induced vomiting
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the safety, efficacy, and pharmacokinetics of ONO-7436 for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adolescent patients aged 12-18 years with malignant tumor in the multicenter, open-label, uncontrolled study.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with malignant tumor who met all of the following criteria 1) through 7) were selected.
    1) Japanese aged 12-18 years (at obtaining the informed consent)
    2) Inpatients (at the start of the study drug administration)
    3) Patients with malignant tumor who are scheduled to receive chemotherapy including any of cisplatin, cyclophosphamide, or carboplatin (the diagnosis should have been confirmed by cytological or histological examination).
    4) Performance Status (ECOG) 0 to 2
    5) Predicted life expectancy not less than 3 months
    6) Patients who are able to accurately record the patient diary
    7) Patients who fulfill the criteria for laboratory tests
    E.4Principal exclusion criteria
    Patients who met any of the following criteria 1) through 16) were excluded.
    1) Patients who are scheduled to receive rescue therapy of stem cell transplantation in parallel with chemotherapy.
    2) Patients who received the following antiemetic drugs within 48 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study drug administration.
    - 5-HT3 receptor antagonists (granisetron, ondansetron, azasetron, etc.)
    - Phenothiazine preparations (chlorpromazine, prochlorperazine, perphenazine etc.)
    - Butyrophenone preparations (haloperidol, droperidol etc.)
    - Benzamide preparation (sulpiride, tiapride, sultopride, etc.)
    - Dopamine receptor antagonists (metoclopramide, itopride, domperidone, etc.)
    - Antihistaminics (hydroxyzine, dimenhydrinate, diphenhydramine)
    - NK1 receptor antagonist (aprepitant)
    3) Patients who started treatment with benzodiazepine preparations or narcotic formulations within 48 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study drug administration.
    - Provided, however, that use of once daily dose (incl. p.r.n.) of ultrashort acting agents (triazolam, midazolam etc.) is accepted. For the examination purpose, using these agents more than once daily as p.r.n. doses is accepted as long as the number of doses is kept to a minimum.
    - When the administration started more than 48 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study drug administration, the continuous use of these medications in the same dosage regimen is accepted.
    4) Patients who started systemic corticosteroid therapy within 72 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study drug administration.
    - However, the enrollment of patients receiving daily steroid therapy for more than 72 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study drug administration is accepted as long as the same dosage regimen of ≤ 10 mg/day prednisolone equivalent is maintained.
    5) Patients who had vomiting or dry vomiting within 24 hours prior to the initial highly or moderately emetogenic chemotherapy on Day 1 of the study.
    6) Patients with symptomatic cerebral metastasis.
    7) Used the following medications within 7 days prior to the study drug administration.
    - Pimozide
    - Clarithromycin
    - Ketoconazole or itraconazole
    8) Used the following medications within 4 weeks prior to the study drug administration.
    - Barbituric acid preparation
    - Rifampicin
    - Phenytoin or carbamazepine
    9) Pregnant women, nursing women, women of child-bearing potential, or women who wish to become pregnant.
    10) Positive to any of syphilis, HBV, HCV, or HIV in haematological tests, or suspected of any of these infections.
    11) Patients who completed other clinical studies within the past 4 weeks.
    12) Patients who are unable to receive dexamethasone phosphate for three days due to associated illnesses such as systemic infection and uncontrolled diabetes mellitus.
    13) Patients having past history of hypersensitivity to granisetron hydrochloride or dexamethasone phosphate.
    14) Patients who have received ONO-7436 in the past.
    15) Patients who appear to be incapable of submitting appropriate informed consent of willingness from the mental and legal viewpoints.
    16) Others judged inappropriate by the principal investigator etc. as subjects for this study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    (1) Proportions of patients with Complete Response (no vomiting, no use of rescue therapy) in the overall, acute and delayed phases.
    (2) Proportions of patients with Total Control (no vomiting, no use of rescue therapy, and no nausea) in the overall phase.
    (3) Proportions of patients (including those who were treated with rescue therapy) with no vomiting in the overall, acute and delayed phases.
    (4) Proportions of patients with no use of rescue therapy in the overall, acute and delayed phases.
    (5) Proportion of patients with no nausea.
    (6) Frequency of vomiting.
    (7) Time to the initial vomiting.
    (8) Time to the initial rescue therapy.

    Safety Endpoints
    1 )Vital signs
    2) Laboratory test
    3) Evaluation and record of adverse events


    Pharmacokinetic Endpoints
    Pharmacokinetic parameters of ONO-7436, such as Cmax, Tmax, AUC, and trough concentration (C24h, C48h, and C72h)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints:
    The starting point of the initial moderately or highly emetogenic chemotherapy on Day 1 of the study drug administration was defined as 0 hour, and the assessment periods of efficacy were 0 to 120 hours as the overall phase, 0 to 24 hours as the acute phase, and 24< to 120 hours as the delayed phase.

    Safety Endpoints
    Throughout the trial

    Pharmacokinetic Endpoints
    24, 48 and 72 hours after first administration
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    Japan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 22
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    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 No
    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 No
    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 22
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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