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    Summary
    EudraCT Number:2011-002947-83
    Sponsor's Protocol Code Number:40085-75083
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002947-83
    A.3Full title of the trial
    Treatment of patients with KRAS wild type advanced colorectal cancer with 5-fluorouracil (5-FU) or 5-FU plus an Epidermal Growth Factor Receptor inhibitor (cetuximab) based on a Comprehensive Geriatric Assessment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of cetuximab for colorectal cancer in elderly and frail patients.
    A.4.1Sponsor's protocol code number40085-75083
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01522612
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportEuropean Organisation for Research and Treatment of Cancer
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer
    B.5.2Functional name of contact pointProject, Budget and Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street AddressAv E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3227441062
    B.5.5Fax number3227441030
    B.5.6E-mailregulatory@eortc.be
    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 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Metastatic Colorectal Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic Colorectal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-FU regimen in elderly/frail patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC) prolongs progression free survival (PFS), compared with 5-FU alone.
    E.2.2Secondary objectives of the trial
    NOT APPLICABLE
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational sub-study on identification of biological aging markers
    E.3Principal inclusion criteria
    1) Male or female patients with pathologically confirmed KRAS WT mCRC
    2) Measurable disease according to RECIST V1.1, patients with not measurable disease will be reviewed by the study coordinator and EORTC HQ, the study sponsor
    3) No prior systemic chemotherapy for metastatic disease
    4) No previous exposure to EGFR or VEGF/VEGFR targeted therapy
    5) Patients may have received chemotherapy in the adjuvant or neo-adjuvant setting for CRC. The treatment-free interval should be 6 months or more from the end of (neo-)adjuvant therapy
    6) Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields
    7) No persistence of clinically relevant treatment-related toxicities from previous chemotherapy and/or radiotherapy (adjuvant or neo-adjuvant setting)
    8) No treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial
    9) Age ≥ 80 or ≥ 70 in combination with functional restrictions defined as limitation in at least 2 of 8 Instrumental Activities of Daily (IADL) Living as described in the protocol
    10) WHO performance status 0, 1 or 2
    11) Adequate bone marrow reserves: absolute neutrophil count ≥1.5 x 109 cells/L, platelets ≥100 x 109 cells/L and uncorrected hemoglobin ≥10g/dL (i.e., without blood transfusion or use of erythropoietin)
    12) Adequate hepatic function: either AST or ALT ≤ 2.5x ULN (in presence of liver metastases, either AST or ALT ≤ 5x ULN), total bilirubin <1.5x ULN
    13) Adequate renal function: GFR > 60 ml/min as measured by Modification of Diet in Renal Disease formula before receiving chemotherapy
    14) Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable, except for GFR.
    15) Normal 12 lead ECG without clinically significant abnormalities
    16) Written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations.
    E.4Principal exclusion criteria
    1) Alcohol or drug abuse
    2)Clinically significant cardiovascular disease:
    -Uncontrolled hypertension
    -New York Heart Association class II-IV congestive heart failure
    -Unstable angina pectoris within the past 12 months.
    -Peripheral vascular disease ≥ grade 2
    -Serious cardiac arrhythmia requiring medication
    -Myocardial infarction within the past 12 months
    -Clinically significant cardiovascular disease
    3) Evidence of uncontrolled medical comorbidities despite adequate treatment (according to treating physician) like :
    -Chronic Obstructive Pulmonary Disease (COPD)
    _Serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral)
    4) Patient who has suffered a cerebrovascular accident or transient ischemic attack within the past 12 months.
    5) History, within the past five years, of malignancies other than CRC (except: adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA < 0.5 ng/ml). Patients with any history of malignancies who are disease-free for more than 5 years are eligible.
    6) Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be discussed with the patient before registration in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is PFS. Progression will be defined according to the “RECIST V1.1”.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, six weeks and then every eight weeks until progressive disease
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. Response Rate (according to the RECIST V1.1)
    3. Comprehensive geriatric assessment (CGA) as evaluated by the elderly minimal dataset (MDS): G8 instrument, instrumental activities of daily living (IADL) and social situation questionnaires and by the short physical performance battery (SPPB)
    4. Quality of Life (EORTC-QLQ C30 and QLQ-ELD15)
    5. Safety profile. Adverse events will be graded according to the "Common Terminology Criteria for Adverse events" CTCAE, version 4.0
    6. Health Economics assessments
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At end of treatment and then every eight weeks until disease progression and then every 12 weeks after that.
    2. End of treatment.
    3. At baseline, on first day of cycles 4, 8, 12 and 20 before treatment administration and then at end of treatment.
    4. At baseline, on first day of cycles 4, 8, 12 and 20 before treatment administration and then at end of treatment.
    5. At baseline, prior to each cycle of treatment, at the end of treatment and then every eight weeks until disease progression and then every 12 weeks after that.
    6. Regularly at study visits from randomisation until death
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - Comprehensive geriatric assessment (CGA)
    - Quality of Life (EORTC-QLQ C30 and QLQ-ELD15)
    - To study whether biological aging markers, inflammatory markers and cytokines correlate with the age at diagnosis of cancer, with disease characteristics and with efficacy and toxicity of chemotherapeutic regimens.

    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    5-fluorouracil/leucovorin (5FU/LV) - standard treatment considered nIMP (background treatment)
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned7
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol: when 110 events for PFS will have been observed in the pooled arms.
    3. The database has been fully cleaned and frozen for this analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After disease progression, further treatment will be at the discretion of the treating physician.
    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 Decision2013-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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