Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43853   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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
    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
    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
    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

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 23 11:40:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA