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    Clinical Trial Results:
    Randomized phase II trial with irinotecan as monotherapy compared to irinotecan and bevacizumab (BevIri) for patients with platinum resistant non-resectable esophagus-, cardia or gastric cancer

    Summary
    EudraCT number
    2012-002321-30
    Trial protocol
    DK  
    Global end of trial date
    02 May 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Mar 2021
    First version publication date
    14 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12.01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløws Vej 2, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Per Pfeiffer, Odense University Hospital, +45 26283844, per.pfeiffer@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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of bevacizumab and irinotecan in combination compared to irinotecan alone in patients with esophagus, cardia or gastric cancer.
    Protection of trial subjects
    Administration of pre-medication to minimize expected adverse events.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Sep 2012
    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
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    26
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    24 months starting September 2012.

    Pre-assignment
    Screening details
    Patients with locally advanced or metastasizing ECV cancer after progression on first line treatment with platinum-based therapy.

    Period 1
    Period 1 title
    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 B: Irinotecan+Bevacizumab
    Arm description
    Irinotecan + Bevacizumab
    Arm type
    Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/kg i.v. infusion over 10 minutes on day 1 every other week.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 i.v. infusion over 30 minutes on day 1 every two weeks.

    Arm title
    Arm A: Irinotecan
    Arm description
    Irinotecan 180 mg/m2 i.v. infusion over 30 minutes on day 1 every two weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 i.v. over 30 minutes on day 1 every two weeks.

    Number of subjects in period 1
    Arm B: Irinotecan+Bevacizumab Arm A: Irinotecan
    Started
    41
    9
    Completed
    41
    9

    Baseline characteristics

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

    Reporting group values
    Trial Total
    Number of subjects
    50 50
    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
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    26 26
        From 65-84 years
    24 24
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    13 13
        Male
    37 37
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in the trial.

    Subject analysis sets values
    Patients
    Number of subjects
    50
    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)
    26
        From 65-84 years
    24
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    13
        Male
    37

    End points

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    End points reporting groups
    Reporting group title
    Arm B: Irinotecan+Bevacizumab
    Reporting group description
    Irinotecan + Bevacizumab

    Reporting group title
    Arm A: Irinotecan
    Reporting group description
    Irinotecan 180 mg/m2 i.v. infusion over 30 minutes on day 1 every two weeks.

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in the trial.

    Primary: Progression-free survival

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    End point title
    Progression-free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 months
    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: The results of this trial were never fully analyzed. Analysis is not available.
    End point values
    Arm B: Irinotecan+Bevacizumab Arm A: Irinotecan Patients
    Number of subjects analysed
    41
    9
    50
    Units: months
        median (confidence interval 95%)
    4.5 (0 to 11)
    5 (0 to 12)
    5 (0 to 12)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Last treatment + 30 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Patients
    Reporting group description
    -

    Serious adverse events
    Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 50 (18.00%)
         number of deaths (all causes)
    15
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Syncope
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical condition
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 50 (50.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 50 (28.00%)
         occurrences all number
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 50 (22.00%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    6

    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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