Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003201-96
    Sponsor's Protocol Code Number:I4X-MC-JFCK
    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:2013-03-20
    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 number2012-003201-96
    A.3Full title of the trial
    A Single-Arm, Multicenter, Open-Label, Phase 2 Study of
    Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab
    (IMC-11F8) in the First-Line Treatment of Patients With
    Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in advanced squamous non small cell lung cancer
    A.4.1Sponsor's protocol code numberI4X-MC-JFCK
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportLilly S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria 30
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916635354
    B.5.5Fax number34916633481
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameNecitumumab
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number 906805-06-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameNECITUMUMAB
    D.3.9.4EV Substance CodeSUB33032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 Yes
    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 nameGemcitabine
    D.3.4Pharmaceutical form 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1250
    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 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCisplatin
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
    cáncer de pulmón no microcítico (CPNM) de histología escamosa y estadio IV
    E.1.1.1Medical condition in easily understood language
    Advanced squamous non small cell lung cancer
    Cancer de pulmon avanzado de histología escamosa
    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 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.1.3Condition 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 estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.
    El objetivo principal de este estudio es estimar las mejores tasas de respuesta objetiva (TRO;
    respuesta completa [RC] + respuesta parcial [RP]) asociadas con el tratamiento con gemcitabinacisplatino
    y necitumumab, en pacientes con CPNM de histología escamosa y estadio IV que no
    hayan recibido quimioterapia previamente
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    ? to evaluate OS, PFS, DCR, and CTS;
    ? to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy;
    ? to characterize pharmacokinetics of necitumumab; and
    ? to determine the immunogenicity of necitumumab.
    Evaluar la SG, la SSP, la TCE y el CTT;
    · Evaluar el perfil de seguridad de necitumumab en combinación con la politerapia
    quimioterápica con gemcitabina-cisplatino;
    · Caracterizar los parámetros farmacocinéticos de necitumumab; y
    · Determinar la inmunogenia de necitumumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed squamous NSCLC
    Stage IV disease at time of study entry based on AJCC 7th edition
    Measurable disease at time of study entry as defined by RECIST 1.1
    [1] El paciente puede proporcionar el consentimiento informado por escrito y está dispuesto a cumplir el calendario y las pruebas del estudio.
    [2] Presentar CPNM de histología escamosa, confirmado histológica o citológicamente.
    [3] Enfermedad en estadio IV en el momento de inclusión en el estudio (de
    acuerdo con el Manuel de estadificación del American Joint Committee on
    Cancer [AJCC], 7ª edición) [Edge et al. 2009]).
    [4] Presentar enfermedad mensurable en el momento de inclusión en el estudio, de acuerdo con los Criterios de Evaluación de la Respuesta de los Tumores Sólidos, versión 1.1 (RECIST 1.1) (Eisenhauer et al. 2009).
    [5] Se ha eliminado el criterio de inclusión [5].
    [6] Edad ? 18 años (o una edad aceptable, de acuerdo con las regulaciones locales [la edad que sea superior]).
    [7] Todos los efectos tóxicos clínicamente significativos (con la excepción de los casos de alopecia) de los tratamientos o intervenciones previas (quimioterapia, intervenciones quirúrgicas, radioterapia u hormonoterapia) deben haberse resuelto a un grado ? 1 de acuerdo con los Criterios Terminológicos Comunes para los Acontecimientos Adversos del Instituto Nacional del Cáncer (NCI-CTCAE), versión 4.0.
    [8] El paciente presenta una categoría funcional del Eastern Cooperative
    Oncology Group de 0-1 (véase el anexo 5).
    [9] El paciente presenta una función hepática adecuada, esto es, una
    concentración de bilirrubina total ? 1,5 veces el límite superior de la
    normalidad y una concentración de aspartato transaminasa (AST) y alanina
    transaminasa (ALT) ? 5,0 veces el LSN (en presencia de metástasis hepáticas) o ? 2,5 veces el LSN (en ausencia de metástasis hepáticas).
    [10] El paciente presenta una función renal adecuada, esto es, una concentración sérica de creatinina ? 1,2 veces el LSN, o un aclaramiento calculado de creatinina ? 50 ml/minuto.
    [11] El paciente presenta una función hematológica adecuada, esto es, un recuento de leucocitos ? 3000/?l, un recuento absoluto de neutrófilos ? 1500/?l, una concentración de hemoglobina ? 9,5 g/dl y un recuento plaquetario ? 100.000/?l.
    [12] En el caso de las pacientes femeninas, deberán haber sido esterilizadas quirúrgicamente, ser posmenopáusicas o seguir un método anticonceptivo muy efectivo (con una tasa de fracaso < 1%) durante el período de tratamiento y los 6 meses posteriores al mismo (un método anticonceptivo hormonal oral no se considera muy efectivo en sí mismo, y deberá utilizarse junto con un método de barrera). En el caso de los pacientes varones, deberán haber sido esterilizados quirúrgicamente o seguir un método anticonceptivo muy efectivo durante el período de tratamiento y los 6 meses posteriores al mismo.
    [13] Las mujeres en edad fértil deberán presentar un resultado negativo en la prueba de embarazo en suero que se realice en el transcurso de los 7 días previos al reclutamiento en el estudio.
    E.4Principal exclusion criteria
    Nonsquamous NSCLC
    Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies
    targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
    Previous chemotherapy for NSCLC
    Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment
    Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions,
    which is allowed)
    Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
    (patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic
    and no longer require treatment with steroids or anticonvulsants, are eligible)
    [14] Estar participando en la actualidad o haber abandonado en el transcurso de los 30 días previos un ensayo clínico en el que se administre un fármaco en fase de investigación, o se haga un uso no recogido en ficha técnica de un fármaco o dispositivo, o estar participando en la actualidad en cualquier otro tipo de investigación médica que se considere que no es compatible con el estudio, desde un punto de vista científico o médico.
    [15] El paciente presenta CPNM de histología no escamosa (adenocarcinoma/células grandes u otros).
    [16] El paciente ha recibido previamente tratamiento antineoplásico con
    anticuerpos monoclonales, inhibidores de la transducción de señales o
    cualquier tratamiento dirigido contra el EGFR, el factor de crecimiento
    endotelial vascular (VEGF) o el receptor del VEGF.
    [17] El paciente ha recibido tratamiento quimioterápico previo para el CPNM.
    [18] El paciente se ha sometido a cirugía mayor o ha recibido cualquier tratamiento en fase de investigación, en el transcurso de las 4 semanas previas al reclutamiento en el estudio.
    [19] El paciente se ha sometido a irradiación del tórax o ha recibido radiación en otras localizaciones tumorales, en el transcurso de las 12 semanas previas al reclutamiento en el estudio (excepto la irradiación paliativa de las lesiones óseas, que sí está permitida).
    [20] El paciente presenta metástasis cerebrales que bien son sintomáticas o requieren la administración de un tratamiento concomitante con esteroides o anticonvulsivos. Se considerarán idóneos para participar en el estudio aquellos pacientes que hayan recibido radioterapia previa para metástasis cerebrales, en la actualidad estén asintomáticos y ya no requieran tratamiento con esteroides o anticonvulsivos.
    [21] Antecedentes de embolismo arterial o venoso en el transcurso de los 6 meses previos al reclutamiento en el estudio.
    [22] El paciente presenta síndrome de la vena cava superior, por lo que la
    hidratación está contraindicada.
    [23] El paciente presenta en la actualidad arteriopatía coronaria clínicamente relevante o insuficiencia cardiaca congestiva sin controlar (grado III o IV, de acuerdo con los criterios de la New York Heart Association) (véase el anexo 8).
    [24] El paciente ha experimentado un infarto de miocardio en el transcurso de los 6 meses previos al reclutamiento en el estudio.
    [25] El paciente presente una infección en curso o activa (que requiera
    antibióticos), entre otras, tuberculosis activa o infección con el virus de la
    inmunodeficiencia humana.
    [26] El paciente presenta antecedentes de trastornos neurológicos o psiquiátricos
    significativos, entre otros, demencia, epilepsia o trastorno bipolar, que
    posiblemente dificultarían el cumplimiento del protocolo.
    [27] El paciente presenta neuropatía periférica de grado ? 2, de acuerdo con los NCI-CTCAE, versión 4.0.
    [28] El paciente presenta cualquier otro trastorno médico o enfermedad psicológica grave sin controlar que, en opinión del investigador, limitaría la capacidad del paciente para completar el estudio o firmar el documento de consentimiento informado.
    [29] El paciente presenta alergia / antecedentes de reacciones de hipersensibilidad a cualquiera de los componentes del tratamiento, incluido cualquier ingrediente utilizado en la formulación de necitumumab, o la administración de alguno de los tratamientos del estudio está contraindicada.
    [30] En relación con las pacientes femeninas, si estas están embarazadas o en período de lactancia.
    [31] El paciente presenta antecedentes de drogadicción.
    [32] El paciente presenta una neoplasia maligna activa concurrente o antecedentes de neoplasias malignas distintas de CPNM, siempre que no haya presentado indicios de la enfermedad durante ? 3 años (salvo los casos de carcinoma basocelular cutáneo o carcinoma preinvasivo del cuello uterino que hayan sido tratados adecuadamente)
    [33] El paciente está recibiendo un tratamiento concomitante con otros fármacos antineoplásicos, entre otros, quimioterapia, inmunoterapia, hormonoterapia, radioterapia, quimioembolización, terapia dirigida o un fármaco en fase de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    To estimate ORR in the study population
    Estimacion de ORR en la poblacion del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 6 months after completing enrollment of the study population
    Aproximadamente 6 meses despues de completar el reclutamiento de la poblacion del estudio
    E.5.2Secondary end point(s)
    - To evaluate OS, PFS, DCR, and CTS;
    - to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy;
    - to characterize pharmacokinetics of necitumumab; and
    - to determine the immunogenicity of necitumumab.
    · Evaluar la SG, la SSP, la TCE y el CTT;
    · Evaluar el perfil de seguridad de necitumumab en combinación con la politerapia
    quimioterápica con gemcitabina-cisplatino;
    · Caracterizar los parámetros farmacocinéticos de necitumumab; y
    · Determinar la inmunogenia de necitumumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 6 months after completing enrollment of the study population
    Aproximadamente 6 meses despues de completar el reclutamiento de la poblacion del estudio
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA11
    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
    Canada
    France
    Korea, Republic of
    Netherlands
    Spain
    Taiwan
    United States
    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
    Refers to the date of the last visit or the last scheduled procedure shown in the study schedule for the last patient (including patients participating in the extension period, if applicable).
    Se refiere a la fecha de la última visita o el último procedimiento previsto que se muestra en el programa del estudio para el último paciente (incluyendo pacientes que participan en el período de extension, si aplica).
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 70
    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)
    After radiographic documentation of progressive disease Investigators may perform standard procedures and tests needed to treat and evaluate patients
    Despues de la documentacion radiologica de la progresion de la enfermedad el investigador podra mandar el tratamiento estandar para la enfermedad y las pruebas necesarias para tratar y evaluar a los pacientes
    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 Decision2013-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-03
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 08:27:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA