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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2005-004782-41
    Sponsor's Protocol Code Number:MO18660
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-004782-41
    A.3Full title of the trial
    A parallel phase II study of Tarceva® (Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) not pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers
    A.4.1Sponsor's protocol code numberMO18660
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameTarceva
    D.3.4Pharmaceutical form Film-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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231/OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25, 100, 150
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with advanced NSCLC not previously treated with chemotherapy
    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
    Efficacy of erlotinib administered as a single agent to chemo-naïve NSCLC patients as determined by the Non Progression Rate (NPR) at 8 weeks.
    The evaluation will be done in the group of never smokers and current/former smokers separately.
    E.2.2Secondary objectives of the trial
    1. To assess the Secondary efficacy parameters as determined by
    • the objective response rate and disease control rate
    • duration of response
    • time to progression
    • progression free survival
    • overall survival
    2. To assess biomarker data on tumour specimen collected prior to erlotinib therapy and correlate with erlotinib treatment outcome
    3. To prospectively evaluate the PK parameters potentially influencing erlotinib activity in never-smoker and current/former smoker group;
    4. To study safety and tolerability of erlotinib in a first-line setting.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Patients with histological documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) NSCLC who have not received prior chemotherapy for advanced disease.
    - Formalin-fixed, paraffin-embedded primary diagnosis lung tumour tissue samples (tissue blocks are preferred over slides) representative of the tumour and collected prior to starting erlotinib therapy will be provided to the co-ordinating investigator. This Is A Mandatory Requirement For Study Entry. Tissue blocks/slides from each site should be sent prior to, or promptly following, the final patient ongoing at that site completing study treatment. HOWEVER, SLIDES ALSO MUST BE SENT WITHIN THREE WEEKS OF PREPARATION.
    - No prior chemotherapy for advanced disease. Previous adjuvant treatment is permitted if patient relapsed >= 1 year after the end of the chemotherapy.
    - Measurable disease according to RECIST.
    - Age 18 or greater.
    - Able to comply with study and follow-up procedures.
    - Patients must be able to take oral medication.
    - Written (signed) Informed Consent (WIC) to participate in the study.
    - ECOG performance status of 0 - 2.
    - Life expectancy of at least 12 weeks.
    - At least 4 weeks since any prior surgery or radiotherapy. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
    - Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin >= 9.0g/dl.
    - Serum bilirubin within upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) < 2.5 x ULN (or =< 5 x ULN in case of liver metastases).
    - Serum creatinine =< 1.5 ULN or creatinine clearance ≥ 60 ml/min.
    - For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. Patients with reproductive potential must use effective contraception.
    - Patients that either can be classified as never smokers or as current/former smokers according to the definitions in the protocol (note that all other smokers (e.g. cigar, pipe) will be excluded from study participation).
    E.4Principal exclusion criteria
    - Any unstable systemic disease including:
    o active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol treatment,
    o uncontrolled hypertension,
    o unstable angina,
    o severe heart disease (NYHA stages III and IV heart failure, unstable angina, uncontrolled arrhythmia in particular)
    o congestive heart failure,
    o history of myocardial infarction within the previous year,
    o serious cardiac arrhythmia requiring medication,
    o hepatic, renal or metabolic disease,
    - Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
    - Patients are excluded if they have clinical evidence of brain metastasis, or have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded.
    - Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the study medication.
    - Previous treatment with any therapy which acts on the EGFR axis.
    - Patients unable to take oral medication, requiring intravenous alimentation, who have malabsorption syndrome or any other condition affecting gastrointestinal absorption, or who have active peptic ulcer disease.
    - Nursing and/or pregnant women.
    - Any inflammatory changes of the surface of the eye.
    E.5 End points
    E.5.1Primary end point(s)
    The two treatment groups in this study will be evaluated separately; no statistical comparison of the results in the two treatment groups is planned.
    The primary efficacy variable is the Non Progression Rate (NPR). The NPR is defined as the proportion of patients without progressive disease (PD) (based on RECIST criteria) at 8 weeks after start of treatment, i.e., all patients with either a complete response (CR), partial response (PR), or stable disease (SD) that is documented for at least 8 weeks from baseline.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 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 trial will end when the last patient has stopped erlotinib treatment and completed his/her final treatment visit (ca. 28 days after last dose administered).
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-19. Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
    Treatment of patients will continue until PD, unacceptable toxicity or death; all patients will be followed every 6 months after end of study medication administration until the end of the study to check their disease and/or survival status.
    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 Decision2006-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-11
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