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    Summary
    EudraCT Number:2006-001961-40
    Sponsor's Protocol Code Number:GI 0607
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2006-001961-40
    A.3Full title of the trial
    Phase II study of therapy with Cetuximab and Irinotecan every second week to Irinotecan resistant patients with metastatic colorectal cancer-effect and biological markers
    A.4.1Sponsor's protocol code numberGI 0607
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Oncology, University Hospital Herlev
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erbitux
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCetuximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    In Denmark there is approximately 3600 new cases of Colorectal cancer every year. In Denmark about half of these patients will eventually develop metastatic disease. In Denmark it is suggested that 150 patients each year will be in such good performance to third line chemotherapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level 1.0
    E.1.2Classification code 10010029
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall response rate.
    E.2.2Secondary objectives of the trial
    To evaluate and determine

    · Time to progression after 1.day of start of therapy.
    · Overall survival from date start of therapy.
    · Safety and toxicity of the treatment
    · Influence of smoking on response to therapy, OS and TTP and other parameters investigated in the protocol.
    · Predictability of metabolic response as evaluated by a PET-scan two weeks after initiation of treatment (optional) on response to therapy, OS and TTP and other parameters investigated in the protocol.
    · The relation between potentially predictive and prognostic tumor biomarkers
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patient with histological proven MCRC.
    2. Patients must have measurable disease, according to RECIST criteria.
    3. Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
    4. Age ≥18 years.
    5. Performance status (WHO) of 0-2.
    6. Patient must have a life expectancy of at least 3 months.
    7. Adequate hematological function defined ANC ³1.5 x 109/l 1. Patient with histological proven MCRC.
    2. Patients must have measurable disease, according to RECIST criteria.
    3. Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
    4. Age ≥18 years.
    5. Performance status (WHO) of 0-2.
    6. Patient must have a life expectancy of at least 3 months.
    7. Adequate hematological function defined ANC ³1.5 x 109/l and platelets ≥100 x 109/l .
    8. Adequate liver function defined as Bilirubin ≤ 1,5 x UNL (upper normal limit) and/or ASAT/ALAT ≤ 5 x UNL.
    9. All should have been exposed to Oxaliplatin-containing therapy.
    10. Written informed consent must be obtained according to the local Ethics Committee requirements.
    platelets 100 x 109/l .
    8. Adequate liver function defined as Bilirubin ≤ 1,5 x UNL (upper normal limit) and/or ASAT/ALAT ≤ 5 x UNL.
    9. All should have been exposed to Oxaliplatin-containing therapy.
    10. Written informed consent must be obtained according to the local Ethics Committee requirements.
    E.4Principal exclusion criteria
    1. Previous or some other concomitant malignancy, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer.
    2. Inability to follow the treatment and evaluation schedule.
    3. Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
    4. Pregnant or lactating women. In fertile women this is ensured by a negative pregnancy test or use of safe antikonception (as defined by the Danish medicines agency during the study period and at least 3 months thereafter.
    5. Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment.
    6. Known hypersensitivity to any of the components of the treatment.
    7. Legal incapacity.
    8. Reduced liver function defined by bilirubin > 5 x UNL or ASAT/ALAT > 5xUNL
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study is finished when a number of 100 evaluable patients have completed the treatment according to the protocol. Evaluable patients are patients included with at least one objective response evaluation two months after initiation of therapy.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-27
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