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    Clinical Trial Results:
    ASSESSMENT OF MULTIDRUG RESISTANCE IN BREAST CANCER AND LOW GRADE GLIOMA PATIENTS WITH [11C]TARIQUIDAR PET. A PILOT STUDY

    Summary
    EudraCT number
    		 2011-004189-13
    Trial protocol
    		 AT  
    Global end of trial date
    31 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgsse 23, Viena, Austria, 1090
    Public contact
    Department of Clinical Pharmacology, Medizinische Universität wien, 0043 1404002981, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Department of Clinical Pharmacology, Medizinische Universität wien, 0043 1404002981, klin-pharmakologie@meduniwien.ac.at
    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
    30 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC and/or at baseline (diagnostic biopsy)
    Protection of trial subjects
    Subjects were during the trail under the supervision of a physician or an experienced Nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2012
    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
    Austria: 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
    		 Subjects were recruited by use of data base of the Dep. of Clinical Pharmacology, Medical University of Vienna.

    Pre-assignment
    Screening details
    		 Check of the in- and exclusion criteria, physical examination, vital signs, laboratory assessment

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group B, Breast cancer
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [11C]tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    60 min, total effective dose <3 mSv for an i.v. injected activity amount of 400 MBq.

    Arm title
    		 Group G, Glioma
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [11C]tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    60 min, total effective dose <3 mSv for an i.v. injected activity amount of 400 MBq.

    Number of subjects in period 1
    		Group B, Breast cancer Group G, Glioma
    Started
    1
    6
    Completed
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

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

    End points

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    End points reporting groups
    Reporting group title
    Group B, Breast cancer
    Reporting group description
    		 -

    Reporting group title
    Group G, Glioma
    Reporting group description
    		 -

    Primary: Correlation of [11C]tariquidar PET imaging outcome parameters at staging with

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    End point title
    		 Correlation of [11C]tariquidar PET imaging outcome parameters at staging with [1]
    End point description
    End point type
    Primary
    End point timeframe
    60 min
    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: Due to unsuccessful recruitment not enough subjects were involved in the study in order to make a statistical analysis.
    End point values
    		 Group B, Breast cancer Group G, Glioma
    Number of subjects analysed
    1
    6
    Units: volume of distribution
        number (not applicable)
    1
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    03.10.2013-31.08.2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    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: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    Nervous system disorders
    Word finding difficulty
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Social circumstances
    Fasting
    Additional description: Dizziness, Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Cold sore
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2015
    Change in study protocol, cover letter and patient information letter
    15 Dec 2015
    Change in patient information letter, study protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Aug 2016
    Unsuccessful recruitment
    -

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