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    Summary
    EudraCT Number:2012-001402-23
    Sponsor's Protocol Code Number:YO28322
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-06-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-001402-23
    A.3Full title of the trial
    A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND,
    PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY
    AND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATION
    WITH 5-FLUOROURACIL, FOLINIC ACID, AND OXALIPLATIN
    (mFOLFOX6) IN PATIENTS WITH METASTATIC HER2-NEGATIVE,
    MET-POSITIVE GASTROESOPHAGEAL CANCER
    ESTUDIO ALEATORIZADO, EN FASE II, MULTICÉNTRICO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE ONARTUZUMAB (MetMAb) EN COMBINACIÓN CON 5-FLUOROURACILO, ÁCIDO FOLÍNICO Y OXALIPLATINO (mFOLFOX6) EN PACIENTES CON CÁNCER GASTROESOFÁGICO HER2-NEGATIVO Y MET-POSITIVO METASTÁSICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not available
    A.4.1Sponsor's protocol code numberYO28322
    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 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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 688 1111
    B.5.5Fax number+41 61 691 9319
    B.5.6E-mailglobal.rochegenentechtrials@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
    D.3.2Product code Ro 549-0258/F01-01
    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.3.10 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
    D.3.2Product code Ro 549-0258/F02-01
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution 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
    GASTROESOPHAGEAL CANCER
    Cáncer gastroesofágico
    E.1.1.1Medical condition in easily understood language
    GASTROESOPHAGEAL CANCER
    Cáncer gastroesofágico
    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 PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    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 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    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
    - To evaluate the efficacy of onartuzumab + mFOLFOX6 compared withplacebo + mFOLFOX6 as measured by overall survival (OS) in patients with previouslyuntreated HER2-negative metastatic gastroesophageal cancer (GEC) classified asMet-IHC 2+ or 3+ (Met 2+/3+ subgroup).
    - To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by OS in patients with previously untreated HER2-negative metastatic GEC classified as Met-IHC 1+, 2+, or 3+ (intent-to-treat [ITT] population).
    - Evaluar la eficacia de onartuzumab + mFOLFOX6 en comparación con placebo + mFOLFOX6, determinada por la supervivencia global (SG), en pacientes con cáncer gastroesofágico (CGE) metastásico HER2-negativo no tratado previamente, clasificado como Met-IHQ 2+ o 3+ (subgrupo de Met 2+/3+).
    - Evaluar la eficacia de onartuzumab + mFOLFOX6 en comparación con placebo + mFOLFOX6, determinada por la SG, en pacientes con CGE metastásico HER2-negativo no tratado previamente, clasificado como Met-IHQ 1+, 2+ o 3+ (población por intención de tratar [IT]).
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of onartuzumab + mFOLFOX6 relative to placebo + mFOLFOX6 as measured by PFS and ORR in the Met 2+/3+ subgroup and in the ITT population.
    - To evaluate the safety of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 in patients with HER2-negative metastatic GEC, focusing on all adverse events, National Cancer Institute Common Terminology Criteria for Adverse Events
    (NCI CTCAE v4.0) Grade >/= 3 adverse events, and Grade >/= 3 laboratory toxicities.
    - To compare patient-reported outcomes (PROs) following treatment with onartuzumab + mFOLFOX6 relative to placebo + mFOLFOX6, as measured by the EORTC QLQ-C30 and its gastric cancer module (the QLQ-STO22), of the two treatment arms in the
    Met 2+/3+ subgroup and in the ITT population.
    - To characterize the pharmacokinetics of onartuzumab when given with mFOLFOX6.
    - To evaluate serum levels and incidence of anti-therapeutic antibodies (ATAs) against onartuzumab.
    - Evaluar la eficacia de onartuzumab + mFOLFOX6 en comparación con placebo + mFOLFOX6, determinada por la SSP y la TRO, en el subgrupo de Met 2+/3+ y en la población IT.
    - Evaluar la seguridad de onartuzumab + mFOLFOX6 en comparación con placebo + mFOLFOX6 en pacientes con CGE metastásico HER2-neg, haciendo hincapié en todos los AA, los AA de grado >/= 3 según los Criterios terminológicos comunes para AA del National Cancer Institute (NCI CTCAE v4.0) y las toxicidades analíticas de grado >/= 3.
    - Comparar los resultados comunicados por los pacientes (RCP) después del tto. con onartuzumab + mFOLFOX6 en comparación con placebo + mFOLFOX6, determinados mediante el QLQ-C30 de la EORTC y su módulo para el cáncer gástrico (QLQ-STO22), de los dos grupos de tto en el subgrupo de Met 2+/3+ y en la población IT.
    - Describir la FC del onartuzumab cuando se administra con mFOLFOX6.
    - Evaluar las concentraciones séricas y la incidencia de anticuerpos antiterapéuticos (AAT) contra onartuzumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, 18 years of age or older.
    - ECOG performance status of 0 or 1.
    - Life expectancy > 3 months.
    - Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable metastatic disease not amenable to curative therapy.
    - Adequate archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tissue for central IHC assay of Met receptor and HER2 status.
    - Tumor (either primary or metastatic lesion) defined as Met positive by IHC (>/= 50% of tumor cells with membrane and/or cytoplasmic staining at weak, moderate, or high intensity)
    - Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
    Patients with peritoneal disease would generally be regarded as having evaluable disease and be allowed to enter the trial.
    - Varones o mujeres de 18 o más años de edad
    - Estado funcional del ECOG de 0 o 1
    - Esperanza de vida > 3 meses
    - Adenocarcinoma del estómago o la UGE confirmado histológicamente, con enfermedad metastásica inoperable y no susceptible de tratamiento curativo
    - Muestra suficiente de tejido procedente de archivo o recién adquirida, fijada en formol e incluida en parafina (FFIP), para el análisis IHQ central del receptor Met y del estado de HER2
    - Tumor (lesión primaria o metastásica) definido como Met positivo mediante IHQ (>/= 50 % de células tumorales con tinción de la membrana o del citoplasma de intensidad leve, moderada o alta)
    - Enfermedad mensurable o no mensurable pero evaluable, según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST v1.1). Se considera, en general, que los pacientes con enfermedad peritoneal tienen enfermedad evaluable y se les permitirá entrar en el ensayo.
    E.4Principal exclusion criteria
    - HER2-positive tumor (primary tumor or metastasis)
    HER2-positivity is defined as either IHC 3+ or IHC 2+/ISH+; ISH positivity is defined as a HER2:CEP17 ratio of >/= 2.0.
    - Previous chemotherapy for locally advanced or metastatic gastric carcinoma Patients may have received either neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to randomization.
    - Prior exposure to experimental treatment targeting either the HGF or Met pathway.
    - History of another malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
    Hematologic, Biochemical, and Organ Function
    - Granulocyte count < 1500/mm3, platelet count < 100,000/mm3,
    and hemoglobin < 9.0 g/dL within 7 days prior to enrollment.
    - Partial thromboplastin time (PTT), international normalized ratio (INR), or prothrombin time (PT) > 1.5 x the upper limit of normal (ULN), except for patients receiving anticoagulation therapy.
    - AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP) >/= 2.5 × ULN (>/= 5 × ULN with liver metastases)
    - Total bilirubin >/= 1.5 × ULN (except in patients diagnosed with
    Gilbert's disease)
    - Serum calcium > ULN (corrected for low serum albumin concentrations) Corrected calcium (mg/dL) = serum Ca2+ + [(4.0-measured serum albumin) x 0.8] Corrected calcium (mmol/L) = serum Ca2+ + 0.02 × (40-serum albumin)
    - Serum creatinine > 1.5 × ULN or calculated creatinine
    clearance < 60 mL/min (Cockcroft and Gault 1976)
    - Uncontrolled diabetes as evidenced by fasting serum glucose
    level > 200 mg/dL
    - Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases (Crohn's disease, ulcerative colitis, etc.)
    - Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or known HIVseropositivity.
    - Major surgery within 4 weeks before start of study treatment, without complete recovery.
    - Tumor HER2-positivo (tumor primario o metástasis). La positividad para HER2 se define como IHQ 3+ o IHQ 2+/HIS+; la positividad mediante HIS se define como un cociente de HER2:CEP17 ? 2,0.
    - Quimioterapia previa para el carcinoma gástrico localmente avanzado o metastásico. Los pacientes podrán haber recibido quimioterapia neoadyuvante o adyuvante, siempre y cuando se completara al menos 6 meses antes de la aleatorización.
    - Exposición previa a un tratamiento experimental dirigido a la vía de HGF o Met.
    - Antecedentes de otro tumor maligno en los 5 años precedentes, con la excepción de carcinoma in situ del cuello uterino, carcinoma cutáneo distinto del melanoma o cáncer de útero en estadio I tratados correctamente u otros tumores malignos con previsión de un desenlace curativo.
    Función hematológica, bioquímica y orgánica
    - Recuento de granulocitos < 1500/mm3, recuento de plaquetas < 100.000/mm3 y hemoglobina < 9,0 g/dl en los 7 previos a la inscripción.
    - Tiempo de tromboplastina parcial (TTP), índice normalizado internacional (INR) o tiempo de protrombina (TP) > 1,5 x el límite superior de la normalidad (LSN), excepto en pacientes que estén recibiendo tratamiento anticoagulante.
    - AST (SGOT), ALT (SGPT) y fosfatasa alcalina (ALP) >/= 2,5 × LSN (>/= 5 × LSN con metástasis hepáticas).
    - Bilirrubina total >/= 1,5 x LSN (salvo en los pacientes diagnosticados de enfermedad de Gilbert).
    - Calcio sérico > LSN (corregido respecto a concentraciones séricas bajas de albúmina). Calcio corregido (mg/dl) = Ca2+ sérico + [(4,0 ? albúmina sérica medida) x 0,8]. Calcio corregido (mmol/l) = Ca2+ sérico + 0,02 x (40 ? albúmina sérica).
    - Creatinina sérica > 1,5 x LSN o aclaramiento de creatinina calculado < 60 ml/min (Cockcroft y Gault, 1976).
    - Diabetes no controlada, demostrada por una glucemia en ayunas > 200 mg/dl.
    - Alteraciones digestivas de importancia clínica, aparte del cáncer gástrico, incluidas las enfermedades digestivas inflamatorias no controladas (enfermedad de Crohn, colitis ulcerosa, etc.).
    - Infección activa conocida por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC), o seropositividad conocida para el VIH.
    - Cirugía mayor en las 4 semanas previas al inicio del tratamiento del estudio, sin recuperación completa.
    E.5 End points
    E.5.1Primary end point(s)
    - One interim efficacy and futility analysis planned for the Met 2+/3+ subgroup occurring at the time of the ITT final analysis, which is triggered by obtaining 67% of total OS information (79 events) from the Met 2+/3+ subgroup and 449 events from the ITT population.
    - Final efficacy analysis for the 2+/3+ subgroup triggered by 118 OS events (this will likely occur after the final analysis of the ITT population).
    - Un análisis intermedio de la eficacia y de futilidad previsto para el subgrupo de Met 2+/3+ en el momento del análisis final IT, que se iniciará cuando se obtenga el 67 % de la información total de SG (79 casos) del subgrupo de Met 2+/3+ y 449 casos de la población IT.
    - Análisis final de la eficacia para el subgrupo de Met 2+/3+, que se iniciará cuando se produzcan 118 episodios de SG (probablemente tendrá lugar después del análisis final de la población IT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS is defined as the time from randomization to death due to any
    cause.
    SG, que se define como el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    E.5.2Secondary end point(s)
    Progression-Free Survival, ORR, Safety, PK and PRO
    Supervivencia Libre de Progresión (SLP), Tasa de respuesta objetiva (TRO), Seguridad, Farmacocinética y resultados comunicados por los pacientes (RCP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final analysis
    Análisis final
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, QoL, Serum levels and incidence of anti-therapeutic
    antibodies (ATAs) against MetMAb
    Tolerabilidad, Calidad de vida, niveles séricos e incidencia de anticuerpos antiterapeuticos (AAT) contra 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 No
    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 Yes
    E.8.2.3.1Comparator description
    mFOLFOX6
    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 EEA52
    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
    Australia
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Guatemala
    Hong Kong
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Panama
    Poland
    Russian Federation
    Singapore
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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 final analysis for the ITT population will occur after 449 deaths have been observed (expected 29 months after first patient in [FPI]), while the final analysis for the Met 2+/3+ subgroup will occur after118 deaths in the Met 2+/3+ subgroup have been observed (expected 38 months after FPI). Follow-up for survival will continue until all patients have either died, or are lost to follow-up, or the Sponsor decides to end the trial, whichever occurs first.
    El análisis final (AF) de la población IT se realizará cuando se observen 449 muertes (previsto 29 meses después de la entrada del 1er paciente [EPP]), mientras que el AF para el subgrupo de Met 2+/3+ tendrá lugar cuando se observen 118 muertes en el subgrupo de Met 2+/3+ (previsto 38 meses después de la EPP). El seguimiento de la supervivencia continuará hasta que todos los pacientes hayan fallecido o se pierdan para el seguimiento, o el promotor decida poner fin al ensayo, lo que ocurra antes
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 338
    F.4.2.2In the whole clinical trial 800
    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, Roche does not have any plans to provide MetMAb or
    other study interventions to patients after the conclusion of the study
    or any earlier withdrawal. Patients who complete or withdraw from the
    study will be moved to appropriate treatment for NSCLC as determined
    by their doctor. However Roche 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.
    Actualmente, Roche no tiene planes de dar MetMAb u otras intervenciones de estudio a los pacientes después del fin del estudio o retiradas prematuras. Los pacientes que completen o se retiren del estudio serán trasladados a un tto adecuado para NSCLC según lo determinado por su médico. Sin embargo, Roche evaluará la conveniencia de seguir dando MetMAb a los pacientes del estudio después de la evaluación de los resultados de eficacia 1ria, y los datos de seguridad recogidos en el estudio.
    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 Decision2012-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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