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    Summary
    EudraCT Number:2018-000663-80
    Sponsor's Protocol Code Number:ONO-7847-03
    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 number2018-000663-80
    A.3Full title of the trial
    ONO-7847 Japanese Clinical Study in Pediatric Patients Multicenter, open-label, uncontrolled study for the prevention of CINV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, open-label, uncontrolled study for the prevention of CINV
    A.4.1Sponsor's protocol code numberONO-7847-03
    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 IVEMEND
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOSAPREPITANT DIMEGLUMINE
    D.3.9.1CAS number 265121-04-8
    D.3.9.3Other descriptive nameFOSAPREPITANT DIMEGLUMINE, ONO-7847
    D.3.9.4EV Substance CodeSUB27096
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    To confirm the safety, efficacy, and pharmacokinetics of ONO-7847 in the prevention of CINV in 6-month to 18-year old pediatric patients with malignant tumors in a 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
    1. Japanese subjects 6 months to 18 years (at the time of informed consent)
    2. Inpatients (at the first treatment with the investigational product)
    3. Pediatric patients with malignant tumors scheduled to receive chemotherapy including any of cisplatin, cyclophosphamide, or carboplatin (with definitive diagnosis by cytology or biopsy)
    4. Life expectancy of at least 3 months
    5. Laboratory test values:
    · Neutrophil count ≥ 1,000/mm3
    · Platelet count ≥ 75,000/mm3
    · AST (GOT) and ALT (GPT) ≤5 x the institutional upper limit of normal (ULN)
    · Total bilirubin ≤ 1.5 x ULN
    · Creatinine ≤ 1.5 x ULN
    6. Patients who could provide blood samples for pharmacokinetic evaluation
    7. If the patient was 12 years or older at the time of informed consent:
    a. ECOG Performance Status of 0 to 2
    b. Ability to accurately keep a symptom diary
    8. If the patient was 6 months to 11 years old at the time of informed consent:
    a. Lansky Play-Performance Score of 60 to 100
    b. Ability to accurately keep a symptom diary, or patients whose vomiting status could be checked at least daily by legal representative, the investigator, the subinvestigator, or any other relevant person
    E.4Principal exclusion criteria
    1. Any patient scheduled to receive stem cell transplantation as rescue therapy in parallel with chemotherapy
    2. Use of any of the following antiemetics within 48 hours prior to the initial moderately or highly emetogenic chemotherapy on Day 1 of investigational product administration
    ·5-HT3 receptor antagonists (granisetron, ondansetron, azasetron, etc.), except for granisetron when used in standard therapy.
    · Phenothiazines (chlorpromazine, prochlorperazine, perphenazine etc.)
    · Butyrophenones (haloperidol, droperidol etc.)
    · Benzamides (sulpiride, tiapride, sultopride, etc.)
    · Dopamine receptor antagonists (metoclopramide, itopride, domperidone, etc.)
    · Antihistamines (hydroxyzine, dimenhydrinate, diphenhydramine)
    · NK1 receptor antagonists (aprepitant, ONO-7847)
    3. Benzodiazepine or narcotic use started within 48 hours prior to the initial moderately or highly emetogenic chemotherapy on Day 1 of investigational product administration
    4. Systemic corticosteroid therapy started within 72 hours prior to the initial moderately or highly emetogenic chemotherapy on Day 1 of investigational product administration
    5. Vomiting or dry vomiting within 24 hours prior to the initial moderately or highly emetogenic chemotherapy on Day 1 of investigational product administration
    6. Symptomatic cerebral metastasis
    7. Use of any of the following medications within 7 days prior to investigational product administration:
    · Pimozide
    · Clarithromycin
    · Ketoconazole or itraconazole
    8. Use of any of the following medications within 4 weeks prior to investigational product administration:
    · Barbiturates
    · Rifampicin
    · Phenytoin and carbamazepine
    9. Pregnant or nursing women, women who may have been pregnant, or women who wished to become pregnant
    10. Positive reaction to, or suspicion of, any of syphilis, HBV, HCV, or HIV in haematological tests
    11. Use of any other study drug within the past 4 weeks
    12. Associated illnesses such as systemic infection and uncontrolled diabetes mellitus that precluded dexamethasone phosphate administration
    13. History of hypersensitivity to granisetron or dexamethasone phosphate
    14. Previous treatment with ONO-7847 or aprepitant
    15. Any patient who could not give appropriate informed consent on his/her own accord via his/her legal representative from a mental or legal viewpoint
    16. Any patient who was judged by the investigator or subinvestigator to be inappropriate for the study for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints
    1. Proportions of patients with Complete Response (no vomiting and no use of rescue therapy) in the overall, acute, and delayed phases
    2. Proportions of patients with no vomiting (including those treated with rescue therapy) in the overall, acute, and delayed phases
    3. Proportions of patients with no use of rescue therapy in the overall, acute, and delayed phases
    4. Proportion of patients with no nausea
    5. Frequency of vomiting
    6. Time to first vomiting
    7. Time to first rescue therapy
    8. Time to first vomiting or rescue therapy

    Safety endpoints
    Safety-related variables are shown below.
    1. Adverse event (AEs)
    2. Adverse reaction (ADRs)
    3. Serious adverse events (SAEs)
    4. Serious adverse drug reactions (SADRs)
    5. Clinical laboratory tests
    6. Discontinuation of investigational product due to ADRs
    7. Vital signs, body weight
    8. Electrocardiography (12-lead ECG)

    Pharmacokinetics endpoints
    maximum aprepitant concentration in plasma (Cmax); time to reach maximum concentration in plasma (Tmax); the area under the plasma concentration-time curve (AUC); elimination half-life (T1/2); and plasma concentrations at 24, 48, and 72 hours after the start of treatment (C24h, C48h, and C72h).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints
    Efficacy was evaluated during the following phases: the overall phase from 0 to 120 hours, the acute phase from 0 to 24 hours, and the delayed phase from < 24 to 120 hours, where “0 hours” was defined as the start of the initial moderately or highly emetogenic chemotherapy on Day 1.

    Safety endpoints
    Throughout the study

    Pharmacokinetics endpoints
    7 time points during study
    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 months1
    E.8.9.2In all countries concerned by the trial days7
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    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 24
    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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