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    Clinical Trial Results:
    Improving the tolerability of the oral targeted anti-cancer drug pazopanib by food intake (DIET)

    Summary
    EudraCT number
    		 2013-004108-20
    Trial protocol
    		 NL  
    Global end of trial date
    09 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF13.05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02138526
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Angela Colbers, Radboud University Nijmegen Medical Centre, +31 243616405, angela.colbers@radboudumc.nl
    Scientific contact
    Angela Colbers, Radboud University Nijmegen Medical Centre, +31 243616405, angela.colbers@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
    15 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part A: To determine the equivalent dose of pazopanib when taken with a continental breakfast compared to 800 mg in fasted state. Part B:To evaluate whether food can reduce the side effects diarrhea and nausea.
    Protection of trial subjects
    Part A Participating patients will be asked for a hospital admission for two days to collect the blood samples. All blood samples will be drawn from a once placed intravenous cannula. A total of 10 blood samples will be taken per admission day. the burden for the participants of this part of the study is considered to be mild. In general the risk for participation in this study is regarded moderate. The risk of suboptimal dosing is minimized by the run in of three patients at 600 mg OD with food. Benefits associated with participating in this study are that patients and their treating physician get insight into pazopanib exposure when taken with a continental breakfast. Part B The participating patients are asked to keep a record on their defecation pattern and nausea experiences during both treatment regiments, at the end of the study period their preference is asked. Therefore the burden for the participants of this part of the study is considered to be low. In general the risk for participation in this study is regarded negligible. Patient receive a bioequivalent dose pazopanib also normal Ctrhough levels will be monitored. Benefits associated with participating in this study are that patients might experience less side effects and the intake of pazopanib will be more easily incorporated in their normal life style.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 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: 97
    Worldwide total number of subjects
    97
    EEA total number of subjects
    97
    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)
    68
    From 65 to 84 years
    28
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in two parts. First, a PK study was performed to establish the bioequivalent dose of pazopanib when ingested with a CB (part 1). This part was designed as an open-label, crossover, multicenter, phase I study conducted in two centers in the Netherlands (Radboudumc (Nijmegen) and Leiden University Medical Center (Leiden).

    Pre-assignment
    Screening details
    		 Adult patients (≥ 18 years) receiving 800 mg pazopanib o.d. with an ECOG performance status of 0−2. The use of proton pump inhibitors was allowed when the proton pump inhibitor was used at the same time throughout the study. Use of substances known to alter Cytochrome P 3A4 metabolism were prohibited. Patients with GI abnormalities were excluded.

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

    Arms
    Arm title
    		 baseline
    Arm description
    		 baseline
    Arm type
    		 Active comparator

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg once daily oral without food

    Number of subjects in period 1
    		baseline
    Started
    97
    Completed
    78
    Not completed
    19
         Lost to follow-up
    1
         Lack of efficacy
    18
    Period 2
    Period 2 title
    PKcurves
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 pazopanib 800mg fasting
    Arm description
    		 pazopanib 800mg fasting
    Arm type
    		 Active comparator

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg once daily oral without food

    Arm title
    		 pazopanib 600mg + food
    Arm description
    		 pazopanib 600mg + food
    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
    600mg once daily oral with food

    Number of subjects in period 2
    		pazopanib 800mg fasting pazopanib 600mg + food
    Started
    78
    78
    Completed
    78
    78

    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
    		 97 97
    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))
    		 60 (28 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 67 67

    End points

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    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 baseline
    Reporting group title
    pazopanib 800mg fasting
    Reporting group description
    		 pazopanib 800mg fasting

    Reporting group title
    pazopanib 600mg + food
    Reporting group description
    		 pazopanib 600mg + food

    Primary: AUC

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    End point title
    		 AUC
    End point description
    End point type
    Primary
    End point timeframe
    24h
    End point values
    		 pazopanib 800mg fasting pazopanib 600mg + food
    Number of subjects analysed
    78
    78
    Units: mg*h/L
        geometric mean (geometric coefficient of variation)
    821 ( 36 )
    895 ( 38 )
    Statistical analysis title
    		 GMR
    Comparison groups
    pazopanib 800mg fasting v pazopanib 600mg + food
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.1 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    1.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.17
    Notes
    [1] - intrasubject comparison, not 156 different subjects in analysis
    [2] - nap

    Adverse events

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    Adverse events information
    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
    all patients
    Reporting group description
    		 -

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (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
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 79 (7.59%)
    Cardiac disorders
    hypertension
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    hair discoloration
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    pneumonia
         subjects affected / exposed
    1 / 79 (1.27%)
         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
    21 Jun 2018
    1. Change in in- and exclusion criteria When according to the treating physician a patient is eligible for pazopanib treatment, the patient is eligible for study participation. 2. Added secondary objective Progression free survival was added as an secondary objective.

    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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    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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