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    Summary
    EudraCT Number:2014-005030-54
    Sponsor's Protocol Code Number:MK-0991-042
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-02-24
    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 number2014-005030-54
    A.3Full title of the trial
    A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of drug concentrations of Young Kids with a fever
    A.3.2Name or abbreviated title of the trial where available
    PK Study in Immunocompromised Young Kids w/ Febrile Neutropenia
    A.4.1Sponsor's protocol code numberMK-0991-042
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/30/2008
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck & Co., Inc.
    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 & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number1267-305-6559
    B.5.5Fax number1267-305-6391
    B.5.6E-maildalya_guris@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 Yes
    D.2.1.1.1Trade name Cancidas
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co., Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCancidas
    D.3.2Product code MK-0991
    D.3.4Pharmaceutical form Powder for concentrate 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 INNCaspofungin acetate
    D.3.9.1CAS number 179463-17-3
    D.3.9.2Current sponsor codeMK-0991
    D.3.9.3Other descriptive nameL-743872
    D.3.9.4EV Substance CodeSUB12476MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Neutropenic immunosuppressed
    E.1.1.1Medical condition in easily understood language
    Treatment of fungal infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and compare caspofungin plasma concentration profiles and pharmacokinetic parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 50 mg/m2/day (maximum of 70 mg/day) IV, to historical data from adult patients administered caspofungin at a daily 50-mg IV dose.
    E.2.2Secondary objectives of the trial
    (1) To compare caspofungin plasma concentration profiles and pharmacokinetics parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 70 mg/m2/day (maximum of 70 mg/day) IV, to historical data from adult patients administered caspofungin at a daily 70-mg IV dose.
    (2) To evaluate the safety and tolerability of caspofungin administered as daily 50- and 70-mg/m2 IV doses in young children between the ages of 3 and 24 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient is 3 to 24 months of age with one or more of the following conditions:
    1) leukemia, lymphoma, or other cancers
    2) bone marrow or peripheral stem transplantation
    3) high dose chemotherapy incurring prolonged neutropenia
    4) aplastic anemia
    • Patient has an absolute neutrophil count <500/mm3 (Note: The patient should have an anticipated duration of neutropenia of ≥10 days.) AND at least 1 recording of fever >38.0°C (oral or tympanic calibrated to oral) within 72 hours of screening.
    E.4Principal exclusion criteria
    • Patient is <3 months or >24 months (2 years) of age (at time of drug administration).
    • Patient has proven or probable invasive fungal infection at the time of
    Enrollment
    • Patient is taking systemic antifungal therapy with the exception of prophylactic fluconazole.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate and compare caspofungin plasma concentration profiles and pharmacokinetic parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 50 mg/m2/day
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 – 28 days
    E.5.2Secondary end point(s)
    Compare caspofungin plasma concentration profiles and pharmacokinetics parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 70 mg/m2/day
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 – 28 days
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 9
    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: 9
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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
    children between the ages of 3 to 24 months of age
    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 32
    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)
    Patient followed per standard of care at end of study treatment period
    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: United States
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