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    Summary
    EudraCT Number:2015-000634-29
    Sponsor's Protocol Code Number:MO29750
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-10
    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 number2015-000634-29
    A.3Full title of the trial
    RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS PEMETREXED OR DOCETAXEL IN ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON SMALL CELL LUNG CANCER PATIENTS PREVIOUSLY TREATED WITH PLATINUM-BASED CHEMOTHERAPY AND CRIZOTINIB
    ESTUDIO DE FASE III MULTICÉNTRICO, ABIERTO, RANDOMIZADO DE ALECTINIB FRENTE A PEMETREXED O DOCETAXEL EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO AVANZADO QUINASA DEL LINFOMA ANAPLÁSICO POSITIVO, TRATADOS PREVIAMENTE CON QUIMIOTERAPIA BASADA EN PLATINO Y CRIZOTINIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Alectinib versus Pemetrexed or Docetaxel in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer
    Estudio de Alectinib frente a Pemetrexed o docetaxel en pacientes con cancer de pulmon no microcitico avanzado quinasa del linfoma anaplásico positivo
    A.4.1Sponsor's protocol code numberMO29750
    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 SponsorRoche Farma, S.A., que representa en España a F. 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 12
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    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 nameAlectinib
    D.3.2Product code RO5424802
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAlectinib
    D.3.9.2Current sponsor codeRo542-4802/F03
    D.3.9.3Other descriptive nameALK INHIBITOR
    D.3.9.4EV Substance CodeSUB117669
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ALIMTA 500 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameALIMTA
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Docetaxel-Actavis 20 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDocetaxel-Actavis
    D.3.4Pharmaceutical form Concentrate for 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 INNDocetaxel
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anaplastic lymphoma kinase-positive (ALK-positive) non-small cell lung cancer (NSCLC)
    CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM) QUINASA DEL LINFOMA ANAPLÁSICO POSITIVO (ALK POSITIVO)
    E.1.1.1Medical condition in easily understood language
    ALK+ NSCLC is a type of cancer that forms in tissues of the lung, and has an alteration in the ALK gene
    CPNM ALK+ es un tipo de cancer que se forma en los tejidos del pulmón, y que tiene una alteración en el gen ALK
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 and compare between treatment groups the efficacy of alectinib versus chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS)
    Evaluar y comparar la eficacia de alectinib frente a quimioterapia entre los grupos de tratamiento, en pacientes con cáncer de pulmón no microcítico (CPNM) avanzado quinasa del linfoma anaplásico (ALK) positivo, tratados previamente con quimioterapia y crizotinib, que se determinará basándose en la supervivencia libre de progresión (SLP) evaluada por el investigador
    E.2.2Secondary objectives of the trial
    ?To evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in patients with measurable CNS metastases at Baseline
    ?To evaluate and compare between treatment arms the PFS (by IRC);objective response rate (ORR); disease control rate (DCR) and duration of response (DOR) in all patients;time to CNS progression in all patients, CNS duration of response (C-DOR), CNS disease control rate (C-DCR) and C-ORR for all patients with baseline CNS metastasis, and overall survival (OS)
    ?To evaluate the safety and tolerability of alectinib compared with chemotherapy in all patients and patients with CNS metastases at Baseline
    ?To characterize the pharmacokinetics of alectinib and its major metabolite(s)
    ?To evaluate and compare time to deterioration (TTD) in patient-reported lung cancer symptoms
    ?To evaluate and compare patient-reported outcomes (PROs) of health-related quality of life (HRQoL) patient functioning and side effects of treatment
    ?Evaluar y comparar el índice de respuesta objetiva en el sistema nervioso central en pacientes que presentan metástasis medibles en el período basal
    ?Evaluar y comparar entre los grupos de tratamiento la SLP, Indice de respuesta objetiva, índice de control de la enfermedad y duración de la respuesta; Tiempo a la progresion en el SNC, duración de la respuesta en el SNC, índice de control de la enfermedad en el SNC e IRO-SNC en todos los pacientes con metástasis en el SNC en el período basal, y supervivencia global (SG)
    ?Evaluar la seguridad y la tolerancia de alectinib comparado con quimioterapia, en todos los pacientes y en los pacientes con metástasis en el SNC en el período basal
    ?Definir la farmacocinética de alectinib y de su metabolito(s) principal(es)
    ?Evaluar y comparar el tiempo hasta el deterioro en pacientes con sintomas de cancer de pulmon
    ?Evaluar y comparar los resultados percibidos por los pacientes relativos a la calidad de vida relacionada con la salud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive
    - Patient had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
    - Prior CNS or leptomeningeal metastases allowed if asymptomatic.
    - Patients with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
    - Measurable disease (by Response Evaluation Criteria in Solid Tumors v1.1) prior to the administration of study treatment
    - Age >=18 years old
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0?2
    - Adequate hematologic and renal function
    - Life expectancy of at least 12 weeks
    - For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
    - For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
    - For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 3 months after the last dose of study drug
    -Presentar diagnóstico de CPNM avanzado o recurrente (en estadio IIIB, que no pueda ser tratado con múltiples modalidades de tratamiento) o metastásico (en estadio IV) confirmado histológica o citológicamente, que sea ALK-positivo
    -Haber recibido previamente dos regímenes de tratamiento sistémico, que deben haber incluido quimioterapia basada en platino y crizotinib
    -Está permitida la inclusión de pacientes con metástasis en el SNC o leptomeníngeas previas, si son asintomáticas
    -Los pacientes con metástasis sintomáticas en el SNC para los cuales la radioterapia no sea una opción adecuada, podrán participar en este estudio
    -Presentar enfermedad medible (de acuerdo con los criterios RECIST v1.1) antes de la administración del tratamiento del estudio
    -Tener ?18 años de edad
    -Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) 0?2
    -Función hematológica y renal adecuada
    -Esperanza de vida de al menos 12 semanas
    -Todas las mujeres potencialmente fértiles deben presentar un resultado negativo en la prueba de embarazo que se realizará en los 3 días previos al inicio del tratamiento del estudio
    -Las mujeres que no estén en fase postmenopáusica (es decir, sin amenorrea no inducida terapéuticamente desde hace >=12 meses) o que no estén esterilizadas quirúrgicamente (es decir, a las que no se les han extirpado los ovarios y/o el útero) deben comprometerse a practicar la abstinencia sexual o a utilizar uno o varios métodos anticonceptivos combinados que tengan una tasa de fallos anual < 1%, durante el período de tratamiento y, como mínimo, hasta 3 meses después de que reciban la última dosis del fármaco del estudio
    -Los varones deben comprometerse a practicar la abstinencia sexual o a utilizar preservativos más un método anticonceptivo adicional que proporcionen conjuntamente una tasa de fallos <1% al año, durante el período de tratamiento y como mínimo hasta 3 meses después de administrar la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    -Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection or in situ carcinoma of the cervix)
    -Patients who have received any previous ALK inhibitor other than crizotinib
    -Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection
    -Patients with liver disease
    -National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
    -History of organ transplant
    -Patients with baseline QTc >470 milliseconds or symptomatic bradycardia
    -Pregnant or lactating women
    -Known HIV positivity or AIDS-related illness
    -Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study
    -Pacientes con antecedentes de neoplasias malignas en los 3 últimos años estan excluidos (exceptuando carcinoma de piel basocelular tratado con intención curativa, cáncer gastrointestinal (GI) precoz tratado con resección endoscópica o carcinoma in situ de cérvix)
    -Pacientes tratados previamente con cualquier inhibidor de ALK que no sea crizotinib
    -Cualquier trastorno GI que pueda afectar a la absorción de medicaciones orales, como síndrome de malabsorción o estado tras resección intestinal mayor
    -Pacientes con enfermedad hepática
    -Presencia de toxicidades de grado ?3, de acuerdo con los criterios NCI CTCAE v4.0, debidas a cualquier tratamiento previo (exceptuando alopecia), que no hayan mostrado mejoría y que se considere estrictamente que van a interferir en la medicación actual del estudio
    -Trasplante de órganos previo
    -Pacientes con QTc basal > 470 mseg o bradicardia sintomática
    -Mujeres embarazadas o en período de lactancia
    -Positividad documentada para VIH o patologías relacionadas con SIDA
    -Cualquier enfermedad o trastorno concomitante clínicamente significativo que pudiera interferir en el tratamiento, o viceversa, así como en el desarrollo del estudio o en la absorción de medicaciones orales o que, de acuerdo con la opinión del investigador principal, supondría un riesgo inaceptable para el paciente en este estudio
    E.5 End points
    E.5.1Primary end point(s)
    PFS as measured by investigator
    SG medida por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 months
    Hasta un maximo de 24 meses
    E.5.2Secondary end point(s)
    1. PFS by Independent Review Committee (IRC)
    2. ORR and C-ORR
    3. DCR and C-DCR
    4. DOR and C-DOR
    5. OS
    6. Time to CNS progression
    7. Incidence of adverse events and serious adverse events
    8. Safety laboratory tests, Vital signs and ECG
    9. Pharmacokinetics of alectinib and metabolite(s)
    10. EORTC QLQ-C30 and EORTC QLQ-LC13 scores and the EuroQoL 5 Dimension (EQ-5D-5L) questionnaire score
    1-SLP medida por el Comite independiente de revisión (IRC)
    2-IRO y SNC-IRO
    3-ICE y SNC-ICE
    4-DR y SNC-DR
    5-SG
    6-Tiempo hasta la progresion en el SNC
    7-incidencia de acontecimientos adversos y acontecimientos adversos graves
    8-Tests de seguridad de laboratorio, signos vitales y ECG
    9-Farmacocinetica del Alectinib y su(s) metabolito(s)
    10-Puntuación en el EORTC QLQ-C30 y EORTC QLQ-LC13 y puntuacion en el cuestionario EuroQoL 5 Dimension (EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-8. Up to 24 months
    9. Pre-dose at Baseline, Week 3 and Week 6
    10. Up to 24 months
    1-8. Hasta un máximo de 24 meses
    9. Pre-dosis en basal, semanas 3 y 6
    10. Hasta un máximo de 24 meses
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To assess exploratory biomarkers
    Evaluar biomarcadores exploratorios
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Belgium
    Bulgaria
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Norway
    Poland
    Portugal
    Russian Federation
    Slovakia
    Spain
    Turkey
    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 end the of study will occur when each patient is followed up for OS for at least 24 months or when 50% of randomized patients have died, whichever occurs first. Study MO29750 will be closed and an updated analysis performed once all patients have either withdrawn or enrolled in the extension study.
    El estudio terminará cuando se haya realizado un seguimiento de la SG en cada paciente durante un mínimo de 24 meses o cuando el 50% de los pacientes randomizados hayan fallecido, dependiendo de lo que ocurra primero. Se cerrará el estudio MO29750 y se realizará un análisis actualizado una vez que todos los pacientes hayan sido retirados del estudio o incluidos en el estudio de extensión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 120
    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)
    Patients who are receiving and benefitting from study treatment at the end of the study may be offered the possibility of rolling over into a long-term extension study, following the approval of this study by CAs and the EC of the respective investigational sites. During the long-term extension study, minimum data will be collected and SAE?s will be reported to Roche and entered into the Roche safety data base.
    Los pacientes que estén recibiendo el tratamiento del estudio y continúen beneficiándose del mismo en el momento de terminar el estudio, podrian pasar a un estudio de extensión a largo plazo, una vez que las autoridades competentes y los comités éticos de los respectivos centros de investigación den su aprobación para dicho estudio. Durante el estudio de extensión a largo plazo, se recogerán datos mínimos, se notificarán los AAG a Roche y se incluirán en la base de datos de seguridad de Roche
    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 Decision2015-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-13
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