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    Clinical Trial Results:
    Proteinuria in patients with bevacizumab (Avastin®): Identification of potential protein biomarker candidates for monitoring treatment side-effects

    Summary
    EudraCT number
    		 2009-010857-10
    Trial protocol
    		 AT  
    Global end of trial date
    28 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2017
    First version publication date
    28 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BEV-PROT-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Medical University of Vienna, Medical University of Vienna, +43 1 40400 32320, andreas.peyrl@meduniwien.ac.at
    Scientific contact
    Medical University of Vienna, Medical University of Vienna, +43 1 40400 32320, andreas.peyrl@meduniwien.ac.at
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Department of Pediatrics, Medical University of Vienna, +43 14040032320, andreas.peyrl@meduniwien.ac.at
    Scientific contact
    Department of Pediatrics, Medical University of Vienna, +43 14040032320, andreas.peyrl@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
    28 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Identification of potential biomarker proteins that (may) appear during bevacizumab therapy
    Protection of trial subjects
    Collection of urine, no pain or stress expected
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2009
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    7
    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
    		 Pediatric patients receiving bevacizumab for therapeutic reasons

    Pre-assignment
    Screening details
    		 Pediatric patients receiving bevacizumab for therapeutic reasons

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Intermediate milestone: Number of subjects
    Receiving bevacizumab: 15
    Number of subjects completed
    		 15

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

    Arms
    Arm title
    		 Arm 1
    Arm description
    		 Patients receiving bevacizumab
    Arm type
    		 Arm 1

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    10mg/kg every second week

    Number of subjects in period 1
    		Arm 1
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 Overall trial

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 15 15
    Age categorical
    Pediatric patients receiving bevacizumab
    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)
    		 7 7
        Adolescents (12-17 years)
    		 8 8
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall trial

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    15
    Age categorical
    Pediatric patients receiving bevacizumab
    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)
    7
        Adolescents (12-17 years)
    8
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Patients receiving bevacizumab

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall trial

    Primary: Arm 1

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    End point title
    		 Arm 1
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks
    End point values
    		 Arm 1 Overall trial
    Number of subjects analysed
    15
    15
    Units: Spots
    15
    15
    Statistical analysis title
    		 Mean +/- standard deviation
    Comparison groups
    Arm 1 v Overall trial
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mean +/- standard deviation
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    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 / 15 (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
    0 / 15 (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 occurred

    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.
    We could not identify any potential protein biomarker candidates.
    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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