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    Summary
    EudraCT Number:2005-002241-39
    Sponsor's Protocol Code Number:BO 18192
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-002241-39
    A.3Full title of the trial
    A multicentre, double-blind randomised, phase III study to evaluate the efficacy of Tarceva or placebo following 4 cycles of platinum-based chemotherapy in patients with histologically documented advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who have not experienced disease progression or unacceptable toxicity during chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    SATURN
    A.4.1Sponsor's protocol code numberBO 18192
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated 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
    Advanced (stage IIIB or IV) NSCLC previously treated with 4 cycles of a platinum-based 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
    To determine if the administration of Tarceva after standard platinum based chemotherapy in the treatment of NSCLC results in improved Progression Free Survival (PFS) when compared to placebo.
    1. In all patients.
    2. In patients who are EGFR protein expression (IHC) positive.
    E.2.2Secondary objectives of the trial
    1. To compare overall survival between the treatment arms for all patients and for patients who are EGFR protein expression (IHC) positive.
    2. To compare PFS between the treatment arms in patients who are EGFR protein expression (IHC) negative
    3. To compare overall survival between the two treatment arms for patients who are EGFR protein expression (IHC) negative
    4. To perform exploratory evaluations of tumour-tissue for biological or genomic determinants of outcome, including EGFR and K-ras mutational status and EGFR and HER2 expression status and other downstream targets.
    5. To compare time to symptom progression between the two treatment arms.
    6. To evaluate the safety profile of administering Tarceva after a standard platinum based chemotherapy in the treatment of NSCLC.
    7. To investigate by a population analysis approach the pharmacokinetics of Tarceva in the target population, including the influence of covariates and to provide posthoc estimates of exposure.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    <Before Chemotherapy>
    - Patients with histologically documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer and who meet the study selection criteria).
    Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy. This Is A Mandatory Requirement For Study Entry.
    - Patients must have measurable disease according to the RECIST criteria (in addition to investigator review, all CT/MRI data will in addition be reviewed by a central reader as confirmatory process). NOTE: Patients who experience CR, PR or SD during chemotherapy are eligible for the Tarceva/placebo study.
    - Previous adjuvant or neo-adjuvant treatment is permitted if completed >= 6 months before start of the chemotherapy phase.
    - ECOG performance status of 0 – 1.
    - Written (signed) Informed Consent for use of tumour samples.

    <After Chemotherapy>
    - Completion, of 4 cycles of an acceptable, standard, platinum based chemotherapy doublet without progression (i.e. CR, PR or SD). This Is A Mandatory Requirement For Study Entry. A maximum interval of 21 days between end of the last chemotherapy cycle and randomisation will be allowed.
    - ECOG performance status of 0 - 1.
    - Life expectancy of at least 12 weeks.
    - Patients must be able to take oral medication.
    - At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study.
    - Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin >= 9.0g/dl.
    - SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases.
    - Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is >= 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN. If alkaline phosphatase is >= 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
    - Serum creatinine =< 1.5 ULN or creatinine clearance > 60 ml/min.
    - Normal serum calcium.
    - For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
    - Male and Female patients with reproductive potential must use 2 effective methods of contraception.
    - Age 18 (or legal age of consent if greater than 18) or greater.
    - Able to comply with study and follow-up procedures.
    - Written (signed) Informed Consent to participate in the randomised part of the study.
    - Patients must be able to effectively read, and understand the local language(s) for which the FACT-L questionnaires are available.
    E.4Principal exclusion criteria
    - No prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzomab).
    - No prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted.
    - Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
    - Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
    - 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 brain metastasis or spinal cord compression that 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.
    - Patients who are at risk (in the investigator’s opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
    - Any inflammatory changes of the surface of the eye.
    - Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
    - Nursing and/or pregnant women.
    - Hypersensitivity to erlotinib (Tarceva) or to any of the excipients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is duration of progression free survival (PFS), defined as the time from randomisation to disease progression or death whichever occurs first.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 Tarceva or placebo treatment and completed his/her final visit (if appropriate).
    If the analysis of PFS is positive, patients on placebo may be allocated to Tarceva, and the study will continue to the analysis of overall survival. If the analysis of PFS is negative, the study will formally end.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 2005-09-16. 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.4.2.2In the whole clinical trial 854
    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)
    If during the course of Tarceva/placebo treatment a patient progresses, the investigator must have the option of selecting the best 2nd line treatment; this may – depending on the patient - include the use of an EGFR-TKI. Thus unblinding of patients in the Tarceva/placebo study will be possible in exceptional cases, if – in the opinion of the investigator – the use of an EGFR-TKI is the only option for 2nd line treatment. Unblinding will be done through a third party (IVRS).
    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 Decision2005-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-09
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