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    Clinical Trial Results:
    Pharmacokinetics and pharmacogenetics of anticancer drugs in infants and young children

    Summary
    EudraCT number
    		 2006-002845-36
    Trial protocol
    		 GB  
    Global end of trial date
    12 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Mar 2019
    First version publication date
    30 Mar 2019
    Other versions
    Summary report(s)
    		 Investigating the pharmacokinetics and dosing of anticancer drugs in infants and young children.

    Trial information

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    Trial identification
    Sponsor protocol code
    PK 2006 09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00897871
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Level 1, Regent Point, Regent Farm Rd, Newcastle upon Tyne, United Kingdom, NE3 3HD
    Public contact
    Prof. Gareth Veal, Northern Institute for Cancer Research, Newcastle University, 44 01912084332, g.j.veal@newcastle.ac.uk
    Scientific contact
    Prof. Gareth Veal, Northern Institute for Cancer Research, Newcastle University, 44 01912084332, g.j.veal@newcastle.ac.uk
    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
    08 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study is designed to :- •Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age <2 years on current dosing schedules. •Compare drug exposures and degree of pharmacokinetic variability in children <2 years with data obtained from published studies in older children. • Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response. •Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants/young children. The feasibility and clinical value of pharmacologically-guided dosing in subsequent studies in this patient population will also be considered.
    Protection of trial subjects
    Patients receiving the IMP were doing so as part of their standard clinical treatment. Blood volumes for samples taken as part of this trial were kept to a minimum and were taken from the patients central line to minimise pain and distress. Where possible PK samples were taken at the same time as clinical samples to keep discard volumes to a minimum.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2007
    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
    United Kingdom: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    63
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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
    		 Recruitment period 22/10/07 to 08/01/13 UK wide (NHS Sites only).

    Pre-assignment
    Screening details
    		 Patients screened by their treating clinician/research nurses as they attended clinic for their standard care against the inclusion criteria stated in the protocol. Patients only excluded during screening if they fail to meet the study inclusion criteria.

    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
    		 Overall Trial
    Arm description
    		 Overall Trial
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Eposin
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.

    Number of subjects in period 1
    		Overall Trial
    Started
    63
    Completed
    63

    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
    		 63 63
    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)
    		 63 63
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 32 32
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Overall Trial

    Primary: Quantification of Carboplatin, Cyclophosphamide and Etoposide plasma levels in infants

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    End point title
    		 Quantification of Carboplatin, Cyclophosphamide and Etoposide plasma levels in infants [1]
    End point description
    End point type
    Primary
    End point timeframe
    Drug levels measured on a single course of treatment for each patient
    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: Final data analysis involved determination of pharmacokinetic parameters for this infant patient population. No formal statistical analysis was required relating to the primary endpoint.
    End point values
    		 Overall Trial
    Number of subjects analysed
    63
    Units: µg/ml
        number (not applicable)
    63
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Per patient - adverse events only to be collected for the cycle of treatment that PK sampling takes place on.
    Adverse event reporting additional description
    Only adverse events directly related to PK sampling were collected for this trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTC
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: The study was a low risk trial simply involving the collection of blood samples following standard treatment. Adverse events were reported through the main clinical trial on which the patients were being treated.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2009
    Change of sponsor from University Hospitals of Leicester NHS Trust to Newcastle upon Tyne Hospitals NHS Foundation Trust. Change in study sponsor accompanied by change in study management to the Northern Institute for Cancer Research, Newcastle University. Changes to protocol relate to change in study sponsor and management only (new protocol version 3.0, 1st October 2009)
    22 Jun 2010
    Change of Principal Investigator at St James Hospital, Leeds. No changes to protocol
    08 Dec 2010
    Change of Principal Investigator at Sheffield Children's Hospital. No changes to protocol
    08 Mar 2011
    Change of Principal Investigator at Alder Hey Children's Hospital, Liverpool. No changes to protocol
    15 Mar 2012
    Change of Principal Investigator at John Radcliffe Hospital, Oxford. No changes to protocol
    15 Mar 2012
    Change of Principal Investigator at Southampton University Hospital NHS Foundation Trust. No changes to protocol
    19 Nov 2012
    Change of Principal Investigator at John Radcliffe Hospital, Oxford. No changes to protocol

    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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