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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:
    Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer

    Summary
    EudraCT number
    2008-006168-12
    Trial protocol
    DK  
    Global end of trial date
    25 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions
    Summary report(s)
    SAE list

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    08.14
    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 4, 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
    03 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objektives are responserate and time to progression.
    Protection of trial subjects
    Administration of pre-medication to minimize adverse events.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jan 2009
    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: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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)
    40
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Jan. 2009-Feb. 2013

    Pre-assignment
    Screening details
    Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum-resistent esophagus- or stomach-cancer. Patients with either adenocarcinoma or planocellular carcinoma can be included in the trial.

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

    Arms
    Arm title
    Experimental
    Arm description
    Cetuximab+Irinotecan
    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
    500 mg/m2 i.v. on day 1 every two weeks.

    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. on day 1 every two weeks.

    Number of subjects in period 1
    Experimental
    Started
    71
    Completed
    71

    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
    71 71
    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)
    40 40
        From 65-84 years
    31 31
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    15 15
        Male
    56 56
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis of all patients included in Odense.

    Subject analysis sets values
    Patients
    Number of subjects
    71
    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)
    40
        From 65-84 years
    31
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    56

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    Cetuximab+Irinotecan

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis of all patients included in Odense.

    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: No statistical analysis has been performed on the 71 patients from Odense. Analysis of 63 patients included in Odense and Aalborg has been performed in the attached publication.
    End point values
    Experimental Patients
    Number of subjects analysed
    71
    71
    Units: months
        median (confidence interval 95%)
    2.8 (1.8 to 3.5)
    2.8 (1.8 to 3.5)
    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.
    Adverse event reporting additional description
    Please refer to the attached SAE list (attached as Summary) and publication.
    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
    6 / 71 (8.45%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    6
    Cardiac disorders
    Ischaemia
    Additional description: Visceral arterial ischemia.
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Pseudomonas infection
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebral vascular occlusion
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Ileus
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    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
    20 / 71 (28.17%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 71 (12.68%)
         occurrences all number
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 71 (11.27%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    3 / 71 (4.23%)
         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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/22244801
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA