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    Clinical Trial Results:
    Increasing pazopanib exposure by splitting intake moments

    Summary
    EudraCT number
    2016-005252-21
    Trial protocol
    NL  
    Global end of trial date
    12 Mar 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Feb 2021
    First version publication date
    22 Feb 2021
    Other versions
    Summary report(s)
    Groenland et al (Clin Pharmacokinet, 2020) - pazopanib split intake

    Trial information

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    Trial identification
    Sponsor protocol code
    N17PSI
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    CCMO dossier number: NL60393.031.17, NL trialregister: NL6137
    Sponsors
    Sponsor organisation name
    Netherlands Cancer Institute
    Sponsor organisation address
    Plesmanlaan 121, Amsterdam, Netherlands, 1066CX
    Public contact
    Steffie Groenland, Netherlands Cancer Institute, s.groenland@nki.nl
    Scientific contact
    Steffie Groenland, Netherlands Cancer Institute, s.groenland@nki.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
    20 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To show whether switching patients from a once daily (QD) to a twice daily (BID) dosing schedule will lead to a significant increase in pharmacokinetic exposure, measured as Cmin and AUC0-24h.
    Protection of trial subjects
    Theoretically, a possible risk of additional toxicity exists, as we expect an increase in exposure by splitting intake moments of pazopanib. However, this risk is minimized by: - The short duration of the intervention (only seven days); - The exclusion of patients with a high Cmin at screenin
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 2017
    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: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients with histological or cytological proof of cancerwith an indication for treatment with pazopanib (i.e., advanced RCC or STS) were eligible for inclusion. Since evidence suggests pazopanib exposure may drop during the first weeks of treatment, all patients needed to be on pazopanib 800 mg QD treatment ≥ 3 weeks prior to start of the study.

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

    Arms
    Arm title
    Arm1
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cross-over pazopanib 800 mg QD or pazopanib 400 mg twice daily

    Number of subjects in period 1
    Arm1
    Started
    11
    Completed
    9
    Not completed
    2
         In one patient, pazopanib treatment was interrupte
    2

    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
    11 11
    Age categorical
    Age
    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
    4 4
        85 years and over
    0 0
        adults
    0 0
    Gender categorical
    gender
    Units: Subjects
        Female
    8 8
        Male
    3 3

    End points

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    End points reporting groups
    Reporting group title
    Arm1
    Reporting group description
    -

    Primary: The primary endpoint of this study was to evaluate whether switching patients from an 800 mg QD to a 400 mg BID dosing schedule would lead to an increase in pharmacokinetic exposure, measured as Cmin and area under the concentration– time curve from zero

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    End point title
    The primary endpoint of this study was to evaluate whether switching patients from an 800 mg QD to a 400 mg BID dosing schedule would lead to an increase in pharmacokinetic exposure, measured as Cmin and area under the concentration– time curve from zero [1]
    End point description
    End point type
    Primary
    End point timeframe
    Time points at day 1 (800 mg QD) were pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h post-dose. Time points at day 8 (400 mg BID) were predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 15, 16, and 24 h post-dose.
    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: See table 2 of publication attached
    End point values
    Arm1
    Number of subjects analysed
    9
    Units: mg/L and h/L
        number (not applicable)
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events should be collected beginning from day 1 of the study and ending with the end of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTC
    Dictionary version
    4.03
    Frequency threshold for reporting non-serious adverse events: 1%
    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: See table 3 of publication attached.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2017
    Erasmus Medical Center added as trial center. Change in data collection (eCRF) Clarification in SAE reporting procedures.
    03 Jul 2018
    -New independent physician -New privacy legislation

    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
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