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    Clinical Trial Results:
    Combined biological treatment and chemotherapy for patients with inoperable cholangiocarcinoma (GOX-P)

    Summary
    EudraCT number
    2008-002367-14
    Trial protocol
    DK   SE  
    Global end of trial date
    31 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Dec 2021
    First version publication date
    29 Dec 2021
    Other versions
    Summary report(s)
    Publication #1
    Publication #2

    Trial information

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    Trial identification
    Sponsor protocol code
    GOX-P
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00779454
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark,
    Public contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    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
    20 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate progression free survival in patients with inoperable cholangiocarcinoma with KRAS mutation treated with combination chemotherapy. To investigate progression free survival in patients with inoperable cholangiocarcinoma without KRAS mutation treated with combination chemotherapy and biological treatment.
    Protection of trial subjects
    Antiemetics and other supportive treatment as necessary.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Oct 2008
    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
    Sweden: 3
    Country: Number of subjects enrolled
    Denmark: 69
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    24
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were included between October 2008 and January 2015

    Pre-assignment
    Screening details
    Institution based screening of all patients with biliary tract cancer.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A, patients with KRAS mutation
    Arm description
    Combination chemotherapy according to institutional guidelines
    Arm type
    Experimental

    Investigational medicinal product name
    Gemcitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 every two weeks

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg/m2 every two weeks

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg/m2 twice daily seven days every two weeks

    Arm title
    Arm B, patients without KRAS mutation
    Arm description
    Combination chemotherapy according to institutional guidelines + panitumumab
    Arm type
    Experimental

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg every two weeks

    Investigational medicinal product name
    Gemcitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 every two weeks

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg/m2 every two weeks

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg/m2 twice daily seven days every two weeks

    Number of subjects in period 1
    Arm A, patients with KRAS mutation Arm B, patients without KRAS mutation
    Started
    26
    46
    Completed
    26
    46

    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
    72 72
    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)
    0 0
        Children (2-11 years)
    0 0
        Adults (18-64 years)
    24 24
        From 65-84 years
    48 48
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    67.5 (37 to 86) -
    Gender categorical
    Units: Subjects
        Female
    48 48
        Male
    24 24

    End points

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    End points reporting groups
    Reporting group title
    Arm A, patients with KRAS mutation
    Reporting group description
    Combination chemotherapy according to institutional guidelines

    Reporting group title
    Arm B, patients without KRAS mutation
    Reporting group description
    Combination chemotherapy according to institutional guidelines + panitumumab

    Primary: PFS at six months

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    End point title
    PFS at six months
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    Arm A, patients with KRAS mutation Arm B, patients without KRAS mutation
    Number of subjects analysed
    26
    46
    Units: Fraction
        arithmetic mean (confidence interval 95%)
    52 (31 to 69)
    74 (58 to 84)
    Statistical analysis title
    Non-parametric
    Statistical analysis description
    Descriptive analyses
    Comparison groups
    Arm A, patients with KRAS mutation v Arm B, patients without KRAS mutation
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.05
    Method
    Fisher exact
    Confidence interval
    Notes
    [1] - Each group described individually.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every 4 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Toxicity
    Reporting group description
    -

    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: Only approved and well-known drugs were given.
    Serious adverse events
    Toxicity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 72 (51.39%)
         number of deaths (all causes)
    69
         number of deaths resulting from adverse events
    0
    Investigations
    Reduced general condition
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    8 / 72 (11.11%)
         occurrences causally related to treatment / all
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Nausea
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Gallbladder obstruction
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
         subjects affected / exposed
    17 / 72 (23.61%)
         occurrences causally related to treatment / all
    20 / 35
         deaths causally related to treatment / all
    0 / 6
    Infection
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences causally related to treatment / all
    11 / 12
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Toxicity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)

    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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