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    Clinical Trial Results:
    Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS

    Summary
    EudraCT number
    		 2013-003533-16
    Trial protocol
    		 NL  
    Global end of trial date
    24 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2021
    First version publication date
    12 Jun 2021
    Other versions
    Summary report(s)
    		 Medical Journal Article

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-ONCO-201303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01995981
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud University Nijmegen Medical Centre
    Sponsor organisation address
    Geert Grooteplein 10, Nijmegen, Netherlands,
    Public contact
    Research verpleegkundigen oncologie, Radboud University Nijmegen Medical Centre, 0031 243610353,
    Scientific contact
    Research verpleegkundigen oncologie, Radboud University Nijmegen Medical Centre, 0031 243610353,
    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
    03 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether early metabolic response is correlated to clinical benefit. And to evaluate the effect of age on pazopanib pharmacokinetcs.
    Protection of trial subjects
    The study included additional PETscans and PK analysis for which only one IV line was used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    12
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in the Radboud University Medical Center in Nijmegen and the Antoni van Leeuwenhoek – Netherlands Cancer Institute in Amsterdam

    Pre-assignment
    Screening details
    		 Inclusion and exclusion criteria were similar to those used in the PALETTE trial: van der Graaf WT, et al. Pazopanib for metastatic soft tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 379: 1879-1886, 2012. PMID: 22595799.

    Period 1
    Period 1 title
    Inclusion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 FDG-PET
    Arm description
    		 The study was designed as a prospective observational feasibility study
    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
    800 mg pazopanib once daily

    Number of subjects in period 1
    		FDG-PET
    Started
    20
    Completed
    20

    Baseline characteristics

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

    Reporting group values
    		 Inclusion Total
    Number of subjects
    		 20 20
    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 (40 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    FDG-PET
    Reporting group description
    		 The study was designed as a prospective observational feasibility study

    Subject analysis set title
    PK AUC0-24h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    AUC 0-24h

    Subject analysis set title
    PK Ctrough
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Ctrough levels

    Primary: FDG-PET/CT can be used for early monitoring of response to pazopanib treatment in STS patients

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    End point title
    		 FDG-PET/CT can be used for early monitoring of response to pazopanib treatment in STS patients [1]
    End point description
    End point type
    Primary
    End point timeframe
    10-10-2013 - 26-5-2017
    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: No statistical analyses were performed as this was a pilot observational study. Only descriptives were given.
    End point values
    Number of subjects analysed
    Units: SULpeak
    No statistical analyses for this end point

    Primary: there is an association between FDG-PET/CT response and pazopanib concentration/exposure

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    End point title
    		 there is an association between FDG-PET/CT response and pazopanib concentration/exposure [2]
    End point description
    End point type
    Primary
    End point timeframe
    oct 2013- may 2017
    Notes
    [2] - 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: No statistical analyses were performed as this was a pilot observational study. Only descriptives were given.
    End point values
    		 FDG-PET
    Number of subjects analysed
    20
    Units: Response
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    oct 2013 - may 2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCTAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Patiënts
    Reporting group description
    		 -

    Serious adverse events
    		 Patiënts
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Hepatobiliary disorders
    Elevated liver enzymes
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspneu
    Additional description: Due to disease progression
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Patiënts
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 20 (65.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    10
    Gastrointestinal disorders
    Decreased appetite due to nausea/altered taste
         subjects affected / exposed
    8 / 20 (40.00%)
         occurrences all number
    8

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30842163
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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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