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    Clinical Trial Results:
    A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokinetics of MK-0991 (Caspofungin) in Japanese Children and Adolescents with Documented Candida or Aspergillus Infections

    Summary
    EudraCT number
    		 2014-004910-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    09 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0991-074
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01165320
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    1
    Children (2-11 years)
    11
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with documented esophageal candidiasis, invasive candidiasis, or aspergillosis and who met all of the additional inclusion and exclusion criteria were to be enrolled in the study.

    Pre-assignment
    Screening details
    		 Three participants were initially enrolled but were withdrawn when their suspected fungal infections were not confirmed. These 3 participants did not receive study drug. No participants with esophageal candidiasis were identified for inclusion in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Participants with Invasive Candidiasis
    Arm description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Caspofungin
    Investigational medicinal product code
    Other name
    CANCIDAS®, MK-0991
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily).

    Arm title
    		 Participants with Aspergillosis
    Arm description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Caspofungin
    Investigational medicinal product code
    Other name
    CANCIDAS®, MK-0991
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily).

    Number of subjects in period 1
    		Participants with Invasive Candidiasis Participants with Aspergillosis
    Started
    12
    8
    Completed
    9
    4
    Not completed
    3
    4
         Clinical adverse experience
    2
    1
         Reason unknown
    -
    1
         Laboratory adverse experience
    1
    -
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Participants with Invasive Candidiasis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.

    Reporting group title
    Participants with Aspergillosis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.

    Reporting group values
    		 Participants with Invasive Candidiasis Participants with Aspergillosis Total
    Number of subjects
    		 12 8 20
    Age, Customized
    Units: Participants
        >=3 months and <2 years
    		 0 1 1
        >=2 years and <12 years
    		 8 3 11
        >=12 years and <18 years
    		 4 4 8
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 9.8 ± 5.2 9.8 ± 5.2 -
    Gender, Male/Female
    Units: Participants
        Female
    		 9 6 15
        Male
    		 3 2 5

    End points

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    End points reporting groups
    Reporting group title
    Participants with Invasive Candidiasis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.

    Reporting group title
    Participants with Aspergillosis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.

    Primary: Percentage of Participants with an Overall Favorable Response to Therapy

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    End point title
    		 Percentage of Participants with an Overall Favorable Response to Therapy [1]
    End point description
    Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
    End point type
    Primary
    End point timeframe
    Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were presented.
    End point values
    		 Participants with Invasive Candidiasis Participants with Aspergillosis
    Number of subjects analysed
    12
    8
    Units: Percentage of Participants
        number (not applicable)
    66.7
    62.5
    No statistical analyses for this end point

    Primary: Percentage of Participants with One or More Drug-Related Adverse Experiences

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    End point title
    		 Percentage of Participants with One or More Drug-Related Adverse Experiences [2]
    End point description
    An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
    End point type
    Primary
    End point timeframe
    Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were presented.
    End point values
    		 Participants with Invasive Candidiasis Participants with Aspergillosis
    Number of subjects analysed
    12
    8
    Units: Percentage of Participants
        number (not applicable)
    58.3
    37.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 56 days for invasive candidiasis; up to 84 days for aspergillosis
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Aspergillosis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.

    Reporting group title
    Invasive candidiasis
    Reporting group description
    		 Caspofungin therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.

    Serious adverse events
    		 Aspergillosis Invasive candidiasis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aspergillosis Invasive candidiasis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
    10 / 12 (83.33%)
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Venoocclusive Disease
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Puncture Site Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    4
    Vessel Puncture Site Inflammation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pulmonary Oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 12 (33.33%)
         occurrences all number
    1
    5
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 12 (25.00%)
         occurrences all number
    1
    4
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood Urine Present
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    3
    Heart Rate Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Platelet Count Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Bone Marrow Failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Febrile Neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Eye disorders
    Ocular Icterus
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Abdominal Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypoaesthesia Oral
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    4
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 12 (33.33%)
         occurrences all number
    1
    7
    Renal and urinary disorders
    Renal Impairment
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Bacterial Infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pseudomembranous Colitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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