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    The EU Clinical Trials Register currently displays   44043   clinical trials with a EudraCT protocol, of which   7319   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).

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    Summary
    EudraCT Number:2006-000418-20
    Sponsor's Protocol Code Number:D1450C00001
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-03-21
    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 ConcernedFinland - Fimea
    A.2EudraCT number2006-000418-20
    A.3Full title of the trial
    A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD)
    A.3.2Name or abbreviated title of the trial where available
    GECO
    A.4.1Sponsor's protocol code numberD1450C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 namegefitinib
    D.3.2Product code ZD1839
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgefitinib
    D.3.9.2Current sponsor codeZD1839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate Chronic Obstructive Pulmonary Disease (COPD)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of gefitinib tablets, 250 mg once daily (OD) on symptoms, mainly cough and sputum production, in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to placebo during a 4-week treatment period
    E.2.2Secondary objectives of the trial
    Assess the effect of gefitinib on lung function by assessing Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Vital Capacity (VC), and Inspiratory Capacity (IC), respiratory symptoms (other than cough) captured by questionnaires as well as recorded in diaries, and Peak Expiratory Flow (PEF).
    Assess safety by collecting nature, incidence and severity of Adverse Events (AEs) including obtaining Electrocardiogram (ECG), vital signs and laboratory safety assessments.
    Effect of phosphorylation of the Epidermal Growth Factor Receptor (EFGR) in bronchial biopsies will be measured in subgroup.
    Number of COPD exacerbations will be assessed at clinical visits in all patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Out-patients, men or post menopausal or surgically sterile women ≥40-≤80years of age.
    2. A clinical diagnosis of COPD with symptoms for at least 2 years (GOLD 2003 guidelines) prior to Visit 1.
    3. A history of chronic cough with sputum production during the last year prior to Visit 1.
    4. FEV1/VC<70% at Visit 1.
    5. Post-bronchodilator FEV1≥50-<80% of PN at Visit 1.
    6. Current or previous smoker with a smoking history equivalent to 10 or more pack years.
    7. Provision of Informed Consent Form could be obtained at an information visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any study related procedures had been performed.
    E.4Principal exclusion criteria
    1. A history of asthma (in accordance with GINA 2002 guidelines).
    2. History of allergic rhinitis.
    3. Use of oral and/or inhaled GCS within 1 month prior to visit 1.
    4. Women of childbearing potential.
    5. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant.
    6. Patients with a history of concurrent idiopathic pulmonary fibrosis/interstitial pneumonia/pneumoconiosis/radiation pneumonia/drug-induced pneumonia.
    7. Exacerbation of COPD within 30 days prior to visit 1 requiring hospitalisation, a course of antibiotics and/or a course of increased doses of oral and/or inhaled GCS and/or parenteral treatment and/or nebulized treatment.
    8. Drug allergy of any kind.
    9. Patients currently treated with warfarin, or patients who have been treated with warfarin within 3 months prior to Visit 1.
    10. Patients with liver transaminases, or bilirubin elevated above upper limit of normal (ULN) should not be included in the study.
    11. Patients suffering from albuminuri (≥2, or equiv.) and/or hematuria should not be included in the study.
    12. Gastrointestinal infections or disease during the last 1 month prior to Visit 1.
    13. A marked baseline prolongation of QT/QTc (eg, repeated demonstrations of a QTc interval >450 ms for females and >430 ms for males).
    14. A history of additional risk factors for Torsade de pointes (eg. heart failure, hypokalemia, family history of Long QT syndrome).
    15. The use concomitant medications that prolong the QT/QTc interval other than albuterol and terbutaline.
    16. Use of oral or ophthalmic non-cardioselective beta-blocking agents.
    17. Body Mass Index (BMI) <18 kg/m2.
    18. Weight<50 kg.
    19. Significant or unstable ischaemic heart disease, arrhytmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator.
    20. Any significant disease or disorder (eg gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or abnormal laboratory tests which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate.
    21. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at Visit 1, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome variable will be cough assessed by different symptom questions included in the following questionnaires; Diary: Clinical COPD Questionnaire (CCQ), Major Symptom questions. Visits: St. George's Respiratory Questionnaire (SGRQ), Community Acquired Pneumonia questionnaire (CAP).
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 Yes
    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 end of study is defined as date of database lock, which is the time point after which no patient will be exposed to study related activities.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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) 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2006-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-12-15
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