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    Summary
    EudraCT Number:2009-017063-42
    Sponsor's Protocol Code Number:ML22606
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-06
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2009-017063-42
    A.3Full title of the trial
    Biomarkers Impact On the response to Treatment with Erlotinib in first line non-small cell lung Cancer with EGFR activating mutations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biomarkers Impact On the response to Treatment with Erlotinib
    A.3.2Name or abbreviated title of the trial where available
    BIOTEC
    A.4.1Sponsor's protocol code numberML22606
    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 SponsorRoche Romania SRL
    B.1.3.4CountryRomania
    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 supportRoche Romania SRL
    B.4.2CountryRomania
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule
    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 183321-74-6
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.3.11.8Extractive medicinal product No
    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 typeTirosin-kinase inhibitor
    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
    Non-small cell lung cancer
    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 progression free survival
    E.2.2Secondary objectives of the trial
    To evaluate time till progression (TTP)
    To evaluate objective response rate
    To evaluate 1-year survival rate.
    To determine the localization of disease progression.
    To establish the profile of patient with EGFR activating mutations, evaluated based on sex, age, incidence of mutations, type of mutations, smoking status
    To collect local epidemiological data such as the incidence of EGFR mutations for Romanian lung cancer patients
    To establish percentage of associations between mutations detected from tumor sample and mutations detected from blood sample for all tested patients (if samples will be available at baseline and testing mutations from blood line will be possible)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (informed consent document to be approved by the National Ethics Committee and consent obtained prior to any study-specific procedure) for biomarkers testing and drug administration
    2. Able to comply with the protocol
    3. Age ≥ 18 years
    4. Histological documented adenocarcinoma, locally advanced - stage IIIb, metastatic - stage IV or recurrent non-squamous NSCLC.
    5. Eastern Cooperative Oncology Group PS status 0-1
    6. Life expectancy ≥ 12 weeks
    7. Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria
    8. Adequate haematological function:
    a. Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
    b. Platelet count ≥100 x 109/L AND
    c. Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
    9. Adequate liver function:
    d. Total bilirubin <1.5 x upper limit of normal (ULN) AND
    e. Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
    10. Normal Serum calcium
    11. Female and male patients with reproductive potential must use effective contraception.
    12. If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of erlotinib, a confirmatory urine test (within 72 hours prior to the first dose of erlotinib) is required.
    E.4Principal exclusion criteria
    1. Inability or unwillingness to provide informed consent
    2. Squamous non-small cell or small cell tumors or absence of histological report
    3. Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
    4. Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
    5. Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor) for the treatment of the patient’s current stage of disease (stage IIIB with pleural or pericardial effusion, stage IV or recurrent disease). NOTE: prior surgery and irradiation is permitted provided that the criteria outlined in the protocol for both treatments are met.
    6. Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy for relief of bone pain not involving the thoracic region is allowed prior to enrolment.
    7. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
    8. Any active, non-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
    9. Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
    10. Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
    11. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
    12. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
    13. Serum creatinine > 1.5 ULN and/or creatinine clearance < 60 mL/min.
    14. 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.
    15. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception (oral contraceptives in case not contraindicated for use with concomitant treatment, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of erlotinib. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib.
    16. Known hypersensitivity to erlotinib or any of its excipients, and any of the chemotherapies
    17. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
    18. Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient’s treating Oncologist and the ophthalmologist
    19. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    20. Counter indications or exclusion criteria, according with SCP of erlotinib
    21. Nursing mothers.
    E.5 End points
    E.5.1Primary end point(s)
    A sample of 30 patients with adenocarcinoma and EGFR activating mutations will enable an evaluation with a 5% type I error (providing a statistical significance with p ≤ 0.05 and a confidence interval of 95%) of the association between the treatment efficacy (treatment response), including the PFS evaluation (progression-free survival) and EGFR-PCR activating mutations.

    Starting from the incidence found in the inventoried trials on patients with EGFR activating mutations and adenocarcinoma ranging between 6% and 28% for Caucasian patients, we estimate that the PCR EGFR testing will be required in approximately 110 patients (at least) and 200 patients (probably more) with adenocarcinoma in order to find the 30 patients to be included in the trial. Patients will be tested until the established number of patients to be included in the study is reached.
    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 No
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    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 No
    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
    LPLV
    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 years0
    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) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2010-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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