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    Clinical Trial Results:
    A pharmacokinetic study of capecitabine in patients undergoing peri-operative chemotherapy and a total gastrectomy for adenocarcinoma of the stomach.

    Summary
    EudraCT number
    2009-009908-39
    Trial protocol
    GB  
    Global end of trial date
    23 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAP002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00871273
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
    Public contact
    Chief Investigator, Cambridge University Hospitals NHS Foundation Trust , 0044 1223216083, cctu.cancer@addenbrookes.nhs.uk
    Scientific contact
    Chief Investigator, Cambridge University Hospitals NHS Foundation Trust , 0044 1223216083, cctu.cancer@addenbrookes.nhs.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
    17 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy
    Protection of trial subjects
    The study was approved by a Research Ethics Committee and received authorisation from the Medicines and Healthcare Products Regulatory Authority. Patients received verbal and written information prior to consenting to the trial and had the time to consider their participation and opportunity to ask questions. Consenting patients had a series of screening tests and exams to ensure they were suitable for the study and that it was safe to proceed. The patients were monitored in the clinic every 3 weeks during the pre-operative and post-operative cycles of treatment for assessment and monitoring of safety. On registration to the trial, the patients were allocated a unique reference number to be used on all data and samples sent to the Sponsor which allowed their personal data to remain anonymous. Only the patients' direct care team had access to their recruited participants personal data during the study. Patients were allowed to withdraw their consent to the study at any time. Patients were withdrawn from the study if they demonstrated disease progression or unacceptable toxicity.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Jul 2010
    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: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    3
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The first patient was recruited on to the study on 29-Jul-2010. The last patient was recruited onto the study on 04-Mar-2013. Patients were recruited from Hospital Oncology clinics.

    Pre-assignment
    Screening details
    Twenty-eight patients were approached for the trial. Of these, 15 did not enter the trial (8 patients declined to participate, 4 patients did not meet the meet the inclusion criteria and 3 patients were not suitable for other reasons). Thirteen patients were screened and were subsequently registered for the trial.

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

    Arms
    Arm title
    Capecitabine
    Arm description
    All registered subjects, planned to receive capecitabine used as part of the ECX combination therapy
    Arm type
    Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda (trade name)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    625 mg/m2, BID, for 21 days for 3 cycles pre-operatively and 3 cycles post-operatively

    Number of subjects in period 1
    Capecitabine
    Started
    13
    Completed
    2
    Not completed
    11
         'Adverse event, serious non-fatal '
    2
         Disease Progression
    1
         WHO PS>=2
    2
         Total gastrectomy not performed
    1
         'Protocol Violation '
    1
         GIST tumour
    1
         'Adverse event, not serious '
    2
         Adverse event, serious fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On-Study
    Reporting group description
    -

    Reporting group values
    On-Study Total
    Number of subjects
    13 13
    Age categorical
    All registered subjects, planned to receive ECX therapy
    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)
    3 3
        From 65-84 years
    10 10
        85 years and over
    0 0
    Age continuous
    All registered subjects, planned to receive ECX therapy
    Units: years
        arithmetic mean (standard deviation)
    68.5 ± 7.8 -
    Gender categorical
    All registered subjects, planned to receive ECX therapy
    Units: Subjects
        Female
    2 2
        Male
    11 11
    WHO performance status
    Units: Subjects
        WHO PS=0
    7 7
        WHO PS=1
    6 6
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects who entered the study for PK sampling

    Subject analysis sets values
    Full Analysis Set
    Number of subjects
    13
    Age categorical
    All registered subjects, planned to receive ECX therapy
    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)
    3
        From 65-84 years
    10
        85 years and over
    0
    Age continuous
    All registered subjects, planned to receive ECX therapy
    Units: years
        arithmetic mean (standard deviation)
    68.5 ± 7.8
    Gender categorical
    All registered subjects, planned to receive ECX therapy
    Units: Subjects
        Female
    2
        Male
    11
    WHO performance status
    Units: Subjects
        WHO PS=0
    7
        WHO PS=1
    6

    End points

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    End points reporting groups
    Reporting group title
    Capecitabine
    Reporting group description
    All registered subjects, planned to receive capecitabine used as part of the ECX combination therapy

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects who entered the study for PK sampling

    Primary: PK parameters for capecitabine AUC (0-infinity)

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    End point title
    PK parameters for capecitabine AUC (0-infinity) [1]
    End point description
    PK parameters for capecitabine AUC (0-infinity): ratio of AUC cycle 4/cycle 1
    End point type
    Primary
    End point timeframe
    cycle 1 to cycle 4
    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: This is a single arm PK study to investigate whether there is a difference in AUC of capecitabine between cycle 4 and cycle 1, measured by the ratio of cycle 4/cycle 1. A total of 5 patients completed both cycles. The mean and standard deviation of this ratio is 2.93 and 1.41, respectively. Using the one-sample t-test, the p-value of the null hypothesis that the ratio =1 is 0.0373.
    End point values
    Capecitabine
    Number of subjects analysed
    5
    Units: ratio
        arithmetic mean (standard deviation)
    2.93 ± 1.41
    Attachments
    CAP002 SAE listing
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From patient registration until 28 days after last study drug administration, regardless of the dose or causal relationship
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NCI CTCAE
    Dictionary version
    3
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Serious adverse events are reported in the file found in the uploaded attachment.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jul 2009
    Substantial amendment in response to non-acceptance. Submission of trial-specific label.
    18 Sep 2009
    Changes to the protocol V2.0 dated 18-Sep-2009 and patient information sheet V2.0 dated 18-Sep-2009 and informed consent form V2.0 dated 18-Sep-2009
    17 Mar 2010
    Changes to the protocol V3.0 dated 17-Mar-2010, patient information sheet and informed consent form V3.0 dated 17-Mar-2010 and GP Letter V1.1 dated 17-Mar-2010

    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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