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    Summary
    EudraCT Number:2011-002224-40
    Sponsor's Protocol Code Number:OAM4971g
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-29
    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 number2011-002224-40
    A.3Full title of the trial
    A randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with Tarceva(erlotinib) in Patients with Met Diagnostic-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Standard Chemotherapy for Advanced or Metastatic Disease
    Uno studio randomizzato, di fase III, multicentrico, in doppio cieco, controllato verso placebo per valutare l' efficacia e la sicurezza di MetMAb in combinazione con Tarceva (Erlotinib) in pazienti con tumore polmonare non a piccole cellule (NSCLC) MET diagnostico-positivo che hanno ricevuto chemioterapia standard per la malattia in stadio avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MetMAb in combination with Tarceva administered to patients with non-small cell lung cancer (NSCLC)
    Uno studio con MetMab In combinazione con Tarceva, somministrato a pazienti con tumore polmonare non a piccole cellule (NSCLC)
    A.4.1Sponsor's protocol code numberOAM4971g
    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 SponsorGENENTECH , INC
    B.1.3.4CountryUnited States
    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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche SpA
    B.5.2Functional name of contact pointCountry Head Clin. Ops. Italy
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039 2475070
    B.5.5Fax number039 2475084
    B.5.6E-mailsergio.scaccabarozzi@roche.com
    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 No
    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 nameMetMab (600mg/10ml)
    D.3.2Product code Ro 549-0258
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOnartuzumab
    D.3.9.1CAS number 1133766-06-9
    D.3.9.2Current sponsor codeRO5490258/PRO143966
    D.3.9.3Other descriptive nameOne Armed anti-cMet, OA5D5, c-Met, Anti-Met
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    D.IMP: 2
    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 No
    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 nameMetMab (900mg/15ml)
    D.3.2Product code Ro 549-0258
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOnartuzumab
    D.3.9.1CAS number 1133766-06-9
    D.3.9.2Current sponsor codeRO5490258/PRO143966
    D.3.9.3Other descriptive nameOne Armed anti-cMet, OA5D5, c-Met, Anti-Met
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    D.IMP: 3
    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, UK
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 codeRO 50-8231
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB16423MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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 No
    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.IMP: 4
    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, UK
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 codeRO 50-8231
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB16423MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 No
    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.IMP: 5
    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, UK
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 codeRO 50-8231
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB16423MIG
    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) 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 No
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MET DIAGNOSTIC−POSITIVE NON−SMALL CELL LUNG CANCER (NSCLC)
    NSCLC in fase IIIB/IV positivo alla diagnostica per la proteina Met precedentemente trattato
    E.1.1.1Medical condition in easily understood language
    Incurable lung cancer (NSCLC)
    Cancro al polmone incurabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025048
    E.1.2Term Lung cancer non-small cell recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine whether the
    combination of MetMAb + erlotinib is superior (in terms of overall
    survival) to placebo + erlotinib after standard platinum-based
    chemotherapy in patients with Met diagnostic−positive NSCLC
    Stabilire se la combinazione di MetMAb+erlotinib sia superiore (in termini di OS) a placebo+erlotinib dopo una chemioterapia standard a base di platino in pazienti affetti da carcinoma polmonare non a piccole cellule (NSCLC) positivo alla diagnostica per il recettore Met
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    • To evaluate and compare the efficacy in terms of progression free
    survival (PFS) and overall response rate (ORR) between the two
    treatment groups
    • To evaluate and compare the safety and tolerability of MetMAb +
    erlotinib versus placebo + erlotinib in patients with Met diagnostic−
    positive NSCLC
    • To evaluate the impact of MetMAb on patient-reported outcome (PRO)
    measures of quality of life
    • To evaluate the pharmacokinetics of MetMAb
    • To evaluate serum levels and incidence of anti-therapeutic antibodies
    (ATAs) against MetMAb and to explore the potential relationship of the
    immunogenicity response with pharmacokinetics, safety, and efficacy
    •Valutare e mettere a confronto l'efficacia in termini di sopravvivenza libera da progressione (PFS) e tasso di risposta obiettiva (ORR) i due gruppi di trattamento
    •Valutare e mettere a confronto la sicurezza e la tollerabilità di MetMAb +erlotinib rispetto alla combinazione placebo+erlotinib in pazienti affetti da NSCLC positivo alla diagnostica per il recettore Met
    •Valutare l'effetto del MetMAb tramite i questionari PRO (Patient Reported Outcome) relativi alla qualità della vita
    •Valutare la farmacocinetica di MetMAb
    •Valutare i livelli sierici e l'incidenza di anticorpi antiterapeutici (ATA) contro MetMAb e studiare il potenziale rapporto tra la risposta immunogenicia e la farmacocinetica, la sicurezza e l'efficacia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH MetMAb STUDY OAM4971g
    OAM4971g (DNA Substudy), 11 July 2011

    ALTRI SOTTOSTUDI:
    Sottostudio sul DNA repository, 11 luglio 2011

    E.3Principal inclusion criteria
    • Signed, written informed consent
    • Male or female, 18 years of age or older
    • ECOG performance status of 0–1
    • Stage IIIb/IV NSCLC
    • Tumor sample to be centrally tested for Met and EGFR (tumor results
    must be Met diagnostic-positive)
    • Prior treatment with at least one platinum-based line of treatment (in
    metastatic stage) and no more than one additional line of chemotherapy
    treatment
    •Consenso informato scritto e firmato prima di qualsiasi procedura di screening specifica dello studio
    •Sesso maschile o femminile, età pari o superiore a 18 anni.
    •Pazienti con stato di performance ECOG pari a 0–1 (vedere Appendice C).
    •NSCLC incurabile in stadio IIIb/IV confermato istologicamente o citologicamente
    •Stato positivo alla diagnostica per il recettore Met (&gt;=50% di cellule tumorali con colorazione della membrana e/o del citoplasma a intensità da moderata a elevata) e risultati dei test sulla mutazione che attiva l'EGFR, così come determinati dal laboratorio centrale
    I requisiti dei campioni di tessuto tumorale sono descritti nella sezione 4.5.1.g.
    •Evidenza radiografica di malattia (malattia misurabile non obbligatoria)
    Le lesioni devono trovarsi al di fuori di un campo precedente irradiato se sono l'unico sito della malattia, a meno che una progressione di malattia non sia stata documentata su tale sito dall'inizio delle radiazioni.
    •Trattamento precedente con almeno una linea di trattamento a base di platino (allo stadio metastatico) e non più di una linea aggiuntiva di trattamento chemioterapico
    La terapia di mantenimento con un regime citotossico diverso dalla terapia di prima linea è considerata una linea terapeutica aggiuntiva. Tuttavia, un cambio di regime sistemico per motivi legati a intolleranza o eccessiva tossicità non costituisce un regime aggiuntivo. Il trattamento combinato con chemioterapia e radiazioni costituisce un regime singolo; la chirurgia non è considerato un regime.
    L'ultimo dosaggio della precedente chemioterapia deve essere somministrato &gt;= 21 giorni prima del Giorno 1 (&gt;=14 giorni per vinorelbina, altri alcaloidi della vinca o gemcitabina)
    È consentita una precedente terapia con radiazioni a condizione che il paziente si sia ripreso da eventuali effetti tossici della stessa e siano trascorsi &gt;7 giorni tra l'ultima frazione e la randomizzazione (si vedano i criteri separati relativi alle metastasi al cervello o al midollo spinale).
    E.4Principal exclusion criteria
    • More than 30 days with an EGFR inhibitor (such as gefitinib, erlotinib,cetuximab)
    • Brain metastasis or spinal cord compression unless treated and stable
    • Another malignancy in the past 3 years
    • Life expectancy less than 12 weeks
    • Abnormal granulocytes, platelets, hemoglobin
    • Abnormal serum AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP),
    bilirubin, albumin, calcium, creatinine
    • Significant history of cardiac disease
    • Serious active infection or other serious medical conditions
    • Inflammatory eye changes
    • Clinically significant gastrointestinal abnormalities
    • Unable to take oral medication, need for intravenous feeding, poor
    absorption, or active peptic ulcer disease
    • Symptomatic hypercalcemia requiring bisphosphonate therapy
    • Patients known to be HIV positive
    • Recent major surgery
    • Pregnant or lactating women
    • Women of childbearing potential or sexually active males who are not
    employing adequate contraception (or practicing complete abstinence)
    a. Relativi al cancro
    •Più di 30 giorni di esposizione a un agente sperimentale o in commercio che può agire inibendo l'EGFR o tossicità nota agli inibitori dell’EGFR che comporta una modifica dei dosaggi, inibitori che includono (ma non si limitano a) gefitinib, erlotinib, e cetuximab.
    •Metastasi al cervello o la compressione del midollo spinale non trattate in maniera definitiva chirurgicamente e/o con radiazioni; o metastasi al sistema nervoso centrale (SNC) precedentemente diagnosticate e trattate o compressione del midollo spinale senza che ci sia evidenza di malattia stabile (imaging clinicamente stabile) per &gt;= 14 giorni.
    •Anamnesi di un’altra malattia maligna nei 3 anni precedenti, a meno che non sia stata curata solo chirurgicamente e il paziente risulti libero da malattia per almeno 3 anni.
    •Aspettativa di vita &lt;12 settimane
    b.Ematologica, biochimica e funzione d’organo
    •Conta granulocitica &lt;1.500/mm3; conta piastrinica &lt; 100.000/mm3 o emoglobina &lt; 9,0 g/dL.
    •AST (SGOT), ALT (SGPT), fosfatasi alcalina (ALP) &gt; 2,5 x limite superiore al normale (ULN)
    •Bilirubina totale &gt; 1,5 X ULN
    •Albumina &gt;=2,5 mg/dL
    •Ipercalcemia non controllata (&gt; 1,5 mmol/L di calcio ionizzato o calcio sierico &gt;ULN)
    •Creatinina sierica &gt; 1,5 X ULN
    c.Generale
    •Anamnesi significativa di patologie cardiache (ad esempio incontrollata pressione sanguigna alta, angina instabile, insufficienza cardiaca congestizia, infarto del miocardio nei 6 mesi precedenti o aritmie ventricolari che richiedono una terapia farmacologica)
    •Infezione grave in corso al momento della randomizzazione o altra condizione medica grave di base che impedirebbe al paziente di ricevere il trattamento del protocollo
    •Ogni cambiamento infiammatorio della superficie dell'occhio (esame oftalmologico non necessario)
    •Anomalie gastrointestinali clinicamente significative, incluse le malattie gastrointestinali infiammatorie non controllate (morbo di Crohn, colite ulcerosa ecc.)
    •Incapacità di assumere farmaci per via orale, necessità di alimentarsi per via endovenosa, precedenti interventi chirurgici che influenzano l'assorbimento o ulcera peptica attiva
    •Ipercalcemia sintomatica che richiede l'uso continuato di terapia con bifosfonati
    I pazienti che si stanno sottoponendo a una terapia a base di bifosfonati per prevenire eventi legati allo scheletro e che non hanno una storia di ipercalcemia clinicamente significativa sono elegibili.
    •Donne incinte o che allattano al seno o che hanno effettuato un test di gravidanza dall'esito positivo nelle 48 ore precedenti l'inizio del trattamento con il farmaco in studio
    •Donne in età fertile (amenorreiche da meno di 1 anno) o uomini sessualmente attivi che non utilizzano metodi contraccettivi adeguati (o che praticano l'astinenza completa)
    •Soggetti noti per essere HIV positivi
    •Eventuali interventi chirurgici maggiori entro 2 settimane prima della randomizzazione
    •Incapacità di comprendere la/e lingua/e in cui sono disponibili i questionari EORTC QLQ C30 e QLQ LC13 (si veda l'Appendice E)
    •Qualsiasi condizione (psicologica, geografica, ecc.) che non consente la conformità allo studio e alle procedure di follow-up
    Nota: I pazienti che necessitano di anticoagulanti (ad esempio warfarina) sono idonei a condizione che si presti un'attenzione maggiore nel monitoraggio dell'INR. Se appropriato da un punto di vista medico e se il trattamento è disponibile, lo sperimentatore potrebbe anche decidere di somministrare a tali pazienti eparina a basso peso molecolare, per la quale non si prevede un'interazione con MetMAb o erlotinib.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    Sopravvivenza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis: when 363 deaths have occurred
    Interim analysis: when 243 deaths have occurred
    Analisi primaria: dopo 363 decessi;
    Interim Analisi: dopo 243 decessi
    E.5.2Secondary end point(s)
    • Progression-free survival
    • Objective response rate
    • Health related quality of life
    • Adverse events
    • Laboratory results
    • Pharmacokinetics
    • Incidence of antibodies against MetMAb
    -PFS (Progression - Free survival)
    -ORR (Objective response rate)
    -qualità della vita
    -eventi avversi
    -risultati clinici di laboratorio
    -farmacocinetica
    -Livelli sierici e incidenza di ATA contro MetMAb
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary analysis: when 363 deaths have occurred
    Interim analysis: when 243 deaths have occurred
    Analisi primaria: dopo 363 decessi;
    Interim Analisi: dopo 243 decessi
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, QoL, Serum levels and incidence of ATAs against MetMab
    Tollerabilità, qualità della vita, Livelli sierici e incidenza di ATA contro MetMAb
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Erlotinib+MetMab vs Erlotinib+Placebo
    Erlotinib+MetMab vs Erlotinib+Placebo
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    Croatia
    Hong Kong
    Israel
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Malaysia
    Peru
    Russian Federation
    South Africa
    Taiwan
    United States
    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
    The study will end after the efficacy analysis takes place; this will occur when approximately 363 deaths have occurred.
    Lo studio terminerà al termine dell'analisi di efficacia. questa verrà fatta dopo che si saranno verificati 363 decessi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months46
    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 months46
    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.1.1Number of subjects for this age range: 0
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 131
    F.4.2.2In the whole clinical trial 480
    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)
    Currently, Genentech does not have any plans to provide MetMAb or other study interventions to patients after the conclusion of the study or any earlier withdrawal. However Genentech will evaluate the appropriateness of continuing to provide MetMAb to study patients after evaluating the primary efficacy outcome measure and safety data gathered in the study.
    attualmente Genentech non ha un programma per il trattamento o l'assistenza per i soggetti al termine della loro partecipazione allo studio. Genentech valuterà se contunuare a fornire MetMab ai pazienti coinvolti nello studio dopo la valutazione dell'esito primario di efficacia e i dati di sicurezza.
    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 Decision2012-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-28
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