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    Clinical Trial Results:
    Influence of an Acidic Beverage (Coca-Cola) on the exposure to Imatinib (GLIvec) after major gastrecTomY in patients with Gastrointestinal Stromal Tumors (ABILITY)

    Summary
    EudraCT number
    		 2014-001044-38
    Trial protocol
    		 NL  
    Global end of trial date
    03 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2019
    First version publication date
    24 Oct 2019
    Other versions
    Summary report(s)
    		 ABILITY PAPER

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF14.01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein zuid 10, Nijmegen, Netherlands,
    Public contact
    David Burger, Radboud University Nijmegen Medical Center, david.burger@radboudumc.nl
    Scientific contact
    David Burger, Radboud University Nijmegen Medical Center, david.burger@radboudumc.nl
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effects of Coca-Cola on the exposure to imatinib in patients with major gastrectomy.
    Protection of trial subjects
    The drug is licensed on the Dutch market for the dose administered. The only intervention is adding Coca-Cola to the dosing regimen, possibly increasing exposure to imatinib. There is no attributable risk for the application of the study protocol to the patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2014
    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
    Netherlands: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 patients with histologically confirmed GIST, who have undergone major gastrectomy and are currently treated or will start imatinib therapy were elibible

    Period 1
    Period 1 title
    screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 screening
    Arm description
    		 -
    Arm type
    		 screening

    Investigational medicinal product name
    imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    none

    Number of subjects in period 1
    		screening
    Started
    7
    Completed
    7
    Period 2
    Period 2 title
    treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 imatinib alone
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400-800mg daily

    Arm title
    		 imatinib + coca cola
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400-800mg + coca cola

    Number of subjects in period 2
    		imatinib alone imatinib + coca cola
    Started
    7
    7
    Completed
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    screening
    Reporting group description
    		 -

    Reporting group values
    		 screening Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (46 to 89) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    screening
    Reporting group description
    		 -
    Reporting group title
    imatinib alone
    Reporting group description
    		 -

    Reporting group title
    imatinib + coca cola
    Reporting group description
    		 -

    Primary: AUC imatinib

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    End point title
    		 AUC imatinib
    End point description
    End point type
    Primary
    End point timeframe
    whole trial
    End point values
    		 imatinib alone imatinib + coca cola
    Number of subjects analysed
    7
    7
    Units: mg*h/L
        geometric mean (confidence interval 95%)
    25 (18 to 34)
    26 (20 to 34)
    Statistical analysis title
    		 geometric mean ratio
    Comparison groups
    imatinib + coca cola v imatinib alone
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 geometric mean ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.14
    Notes
    [1] - intrasubject comparison, 7 subjects in total, not 14

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    imatinib
    Reporting group description
    		 -

    Serious adverse events
    		 imatinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 imatinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were reported

    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? Yes
    Date
    Interruption
    Restart date
    03 Nov 2016
    Slow inclusion rates in this study as only a low number of patients with GIST have a gastrectomy, which was an inclusion criterium.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28677263
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    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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