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    Clinical Trial Results:
    Pharmacokinetics and metabolic activation of capecitabine when given concomitantly with oxaliplatin and the monoclonal antibody cetuximab

    Summary
    EudraCT number
    		 2011-002921-23
    Trial protocol
    		 AT  
    Global end of trial date
    27 Mar 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AGMT-Capecet_PK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01579357
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AGMT
    Sponsor organisation address
    Gentzgasse 60/20, Vienna, Austria, 1180
    Public contact
    Daniela Wolkersdorfer, AGMT, 0043 6626404411, d.wolkersdorfer@agmt.at
    Scientific contact
    Richard Greil, AGMT, 0043 5725525801, r.greil@salk.at
    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
    27 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).
    Protection of trial subjects
    Pretreatment before Cetuximab and chemotherapie was recommended. No additional investigating products, anti-tumoural drugs or drugs interacting with the EGFreceptor were allowed. Hematopoietic growth factors such as G-CSF could be used to treat neutropenia but should not be used prophylactically. Safety was monitored by reporting of clinical adverse events.
    Background therapy
    		 Capecitabine 1000mg/m² bid q7d week 1,2,4,5,7 and 8 Oxaliplatin 130mg/m² iv day 1 week 7
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Mar 2012
    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
    Austria: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    15
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 06-Mar-2012 and 07-Jan-2014 28 patients were enrolled at two sites in Austria.

    Pre-assignment
    Screening details
    		 Patients with histologically confirmed K-ras wild-type adenocarcinoma of the colon or rectum without previous chemotherapy for metastatic disease were screened for this study. Subjects who did not complete the entire study due to withdrawal or discontinuation for any reason were replaced.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Capecitabine in weeks 1, 2, 4, 5, 7 and 8 Cetuximab in weeks 3 to 9 Oxaliplatin in week 7
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cetuximab 400mg/m² (loading dose) or 250mg/m² iv day 1 week 3 to 9

    Arm title
    		 Arm B
    Arm description
    		 Capecitabine in weeks 1, 2, 4, 5, 7 and 8 Cetuximab in weeks 1, 8 and 9 Oxaliplatin in week 7
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cetuximab 400mg/m² (loading dose) or 250mg/m² iv day 1 week 1, 8 and 9

    Number of subjects in period 1
    		Arm A Arm B
    Started
    15
    13
    Completed
    12
    12
    Not completed
    3
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    2
    -
         Lack of efficacy
    -
    1

    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
    		 28 28
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Capecitabine in weeks 1, 2, 4, 5, 7 and 8 Cetuximab in weeks 3 to 9 Oxaliplatin in week 7

    Reporting group title
    Arm B
    Reporting group description
    		 Capecitabine in weeks 1, 2, 4, 5, 7 and 8 Cetuximab in weeks 1, 8 and 9 Oxaliplatin in week 7

    Primary: A metabolic activation of CCB modulated by co-administered CETUX

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    End point title
    		 A metabolic activation of CCB modulated by co-administered CETUX [1]
    End point description
    The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of CCB and when this regimen is given combined with OxPt.
    End point type
    Primary
    End point timeframe
    9 weeks of study treatment per 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: No data available up to this date
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Patients
    Notes
    [2] - No data available up to this date
    [3] - No data available up to this date
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All (serious) adverse events occurring during study treatment were collected until 28 days after the end of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 28 (28.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic complication
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Performance status decreased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 28 (100.00%)
    Blood and lymphatic system disorders
    NA
    Additional description: No data available up to this date
         subjects affected / exposed
    28 / 28 (100.00%)
         occurrences all number
    28

    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
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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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