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    The EU Clinical Trials Register currently displays   35865   clinical trials with a EudraCT protocol, of which   5890   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-005515-10
    Sponsor's Protocol Code Number:0869-134
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-12
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2006-005515-10
    A.3Full title of the trial
    A Multi-center, Open-label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Children Receiving Emetogenic Chemotherapy
    A.4.1Sponsor's protocol code number0869-134
    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 SponsorMerck Sharp & Dohme Corp
    B.1.3.4CountryUnited States
    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 supportMerck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme (Sweden) AB
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressBox 7125
    B.5.3.2Town/ citySollentuna
    B.5.3.3Post codeSE-192 07
    B.5.3.4CountrySweden
    B.5.4Telephone number+468578 135 00
    B.5.5Fax number+468754 15 00
    B.5.6E-mailchristina.alm@merck.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 nameAprepitant
    D.3.2Product code MK-0869
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.1CAS number 170729-80-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    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 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.3.1Product nameIVEMEND
    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.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    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)
    E.1.1.1Medical condition in easily understood language
    Nausea and vomiting due to chemotherapy
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10036899
    E.1.2Term Prophylaxis against chemotherapy induced vomiting
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10056989
    E.1.2Term Nausea post chemotherapy
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1 To estimate aprepitant plasma concentration profiles and pharmacokinetic parameters (AUC0-24, Cmax, Tmax, and C24 hr, on day 2 and day 3) obtained in patients 6 months to < 2- years, 2 to < 6 years, and 6 to < 12 years of age receiving moderately or highly emetogenic chemotherapy or a chemotherapy regimen not previously tolerated due to nausea and/or vomiting administered 3 day oral aprepitant with or without fosaprepitant.

    Refer to protocol for additional main objectives.
    E.2.2Secondary objectives of the trial
    Exploratory Objectives:
    1. To explore the efficacy of oral aprepitant administered as a single and three-day dose in addition to the 5HT3 antagonist, ondansetron in the control of CINV in patients 6 months to < 2- years, 2 to < 6 years, and 6 to < 12 years.
    2. To explore the efficacy of Day 1 intravenous fosaprepitant with Day 2 and 3 oral aprepitant in addition to the 5HT3 antagonist, ondansetron in the control of CINV in patients 6 months to < 2 years, 2 to < 6 years, 6 to < 12 years, and 12 to 17 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is 6 months to 17 years of age at the time of study entry.
    2. Patient is scheduled to receive moderately or highly emetogenic chemotherapy for a documented malignancy as defined OR patient did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
    3. Patient is expected to receive ondansetron as part of their antiemetic regimen.
    4. Female patient who has begun menses has a negative urine pregnancy test prior to randomization.
    5. Patients weight ≥ 7.5 kg.
    6. Patient has a preexisting functioning central or venous catheter prior to receiving aprepitant/fosaprepitant designated for pharmacokinetic sampling.
    For Parts I and V only: a double lumen central venous catheter or a single lumen central venous catheter (for fosaprepitant administration) along with a peripheral venous catheter (for pharmacokinetic sampling) is required.
    E.4Principal exclusion criteria
    1. Patient is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy.
    2. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with casopitant or has taken a non-approved (investigational) drug within the last 4 weeks.
    Note: Patients on investigational studies with marketed chemotherapeutic agents are allowed to enroll if they fulfill all other entry criteria
    3. Patient is allergic to aprepitant, fosaprepitant, ondansetron or any other 5 HT3 antagonist.
    4. Patient has a symptomatic primary or metastatic CNS malignancy.
    5. Patient must meet all satisfy all laboratory value criteria as stated in the protocol.
    6. Patient has been treated with specified antiemetic agents within 48 hours prior to Study Day 1.
    7. Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of their chemotherapy regimen.
    Exceptions:
    - Patients who are receiving chronic (>72 hours), daily steroid therapy can be enrolled provided the steroid dose is not >0.14 mg/kg up to 10 mg of prednisone daily or equivalent.
    - Patients are allowed to receive a single dose of a corticosteroid within 3 days prior (but not on the day of study drug administration) provided it is < the equivalent of 20 mg of prednisone.
    - Patients are allowed to receive corticosteroids administered for antiemetic prophylaxis starting on study Day 1.
    8. Patient is taking, or has taken within 7 days of study drug administration the following CYP3A4 substrates:
    - Terfenadine, cisapride, astemizole, pimozide, and amifostine
    9. Patient is taking, or has taken within the 7 days of Treatment Day 1 the following CYP3A4 inhibitors:
    - Clarithromycin, erythromycin, ketoconazole, itraconazole, fluconazole, telithromycin
    10. Patient is taking, or has taken within 30 days of Study Day 1 the following CYP3A4 inducers:
    - Barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine, and St. Johns Wort
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic Endpoint: Aprepitant plasma pharmacokinetic (PK) profile (AUC0-24, Cmax, Tmax, and C24 hr) of the administered dose of either fosaprepitant or aprepitant on Day 1 from pediatric patients aged 6 months to 17 years will be determined. In addition, for Parts I, IV, and V, aprepitant plasma PK will be assessed 24 hr post administration of aprepitant on Day 2 and Day 3.
    Safety Endpoint: Drug-related, serious, and serious drug-related adverse experience(s) during fosaprepitant and/or aprepitant therapy plus 14 days post therapy or drug-related adverse experience(s) leading to discontinuation of fosaprepitant or aprepitant therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours post administration
    E.5.2Secondary end point(s)
    No Vomiting (no vomiting, retching, or dry heaves) and Complete Response (no vomiting and no use of rescue medication) outcomes will be determined by diary reporting of vomiting episodes and/or use of rescue medication. Recorded in the diary will be the time of day and date for any vomiting or retching episodes or use of rescue medication.
    E.5.2.1Timepoint(s) of evaluation of this end point
    No Vomiting, regardless of use of rescue medication, and Complete Response outcomes will be summarized at 3 time periods: 0 to 24 (acute), 25 to 120 (delayed), and 0 to 120 (overall) hours post initiation of chemotherapy. The time period of most interest will be 0 to 120 hours. Of note, Part II of the study will only access efficacy for 0 to 24 hours post initiation of chemotherapy.
    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) Yes
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Colombia
    France
    Germany
    Mexico
    Norway
    Spain
    Sweden
    Switzerland
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 82
    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: 18
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 42
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    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 Yes
    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
    Small children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 82
    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)
    Not applicable, expected normal treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-10
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