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    Summary
    EudraCT Number:2011-004792-36
    Sponsor's Protocol Code Number:CA209-017
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-07
    Trial 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 number2011-004792-36
    A.3Full title of the trial
    An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
    Ensayo fase III abierto, aleatorizado, de BMS-936558 frente a docetaxel en cáncer de pulmón no microcítico (CPNM) epidermoide avanzado o metastásico y tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-936558 compared to Docetaxel in previously treated advanced or metastatic Squamous cell NSCLC
    A.4.1Sponsor's protocol code numberCA209-017
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameBMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNBMS-936558-01
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameAnti-PD-1 Human Monoclonal Antibody; MDX-1106
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Taxotere 160 mg (20 mg/mL)
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    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 nameDocetaxel
    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.3.9.4EV 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
    Squamous cell Non-small cell lung cancer
    cáncer de pulmón no microcítico (CPNM) epidermoide avanzado o metastásico y tratado previamente
    E.1.1.1Medical condition in easily understood language
    Squamous cell Non-small cell lung cancer
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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 purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy
    Comparar la TRO y la SG de BMS-936558 frente a docetaxel en sujetos con CPNM epidermoide después del fracaso de quimioterapia previa basada en platino.
    E.2.2Secondary objectives of the trial
    1.To compare the progression-free survival (PFS) of BMS-936558 versus docetaxel
    2.To evaluate clinical benefit in terms of ORR and OS of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups
    3.To evaluate durability of and time to objective response in BMS-936558 and docetaxel groups
    4.To evaluate the proportion of subjects exhibiting disease-related symptom progression, as measured by LCSS, in BMS-936558 and docetaxel groups
    ?Comparar la supervivencia libre de progresión (SLP) con BMS-936558 frente a docetaxel
    ?Evaluar el beneficio clínico en términos de TRO y SG de BMS-936558 frente a docetaxel en los subgrupos según expresión de la proteína PD-L1, PD-L1 + frente a PD-L1
    ?Evaluar la durabilidad de y el tiempo hasta la respuesta objetiva en los grupos de BMS-936558 y docetaxel
    ?Evaluar la proporción de sujetos que muestran progresión de los síntomas relacionados con la enfermedad, medida con la LCSS, en los grupos de BMS-936558 y docetaxel
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, dated 12-Jun-12)

    The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood sample and health information collected from the main clinical trial, CA209017 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of lung cancer. Samples from this study
    may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective.
    Enmienda sobre muestras de sangre para farmacogenética
    de fecha 12-jun-2012
    El objetivo de esta enmienda es permitir la recogida y la conservación de muestras de sangre para uso en estudios de investigación farmacogenética exploratorios futuros. Bristol-Myers Squibb usará el ADN obtenido de la muestra de sangre y la información de salud recogida del cuaderno de recogida de datos del ensayo clínico principal, CA209017, para estudiar la asociación entre la variación genética y la respuesta a los medicamentos. Bristol-Myers Squibb también puede usar el ADN para estudiar las causas y progresión adicional del cáncer de pulmón. Para conseguir este objetivo pueden usarse conjuntamente muestras de este y otros estudios de investigación farmacogenética.
    E.3Principal inclusion criteria
    1) men & women ? 18 years of age
    2) Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection.
    3) Disease recurrence or progression during/after one prior platinum-containing chemotherapy regimen for advanced or metastatic disease
    4) Measurable disease by CT/MRI per RECIST 1.1 criteria
    5) ECOG performance status ? 1
    6) An FFPE tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
    1. Varones y mujeres ? de 18 años y más.
    2. Sujetos con CPNM epidermoide documentado histológicamente o citológicamente que presenten enfermedad en estadio IIIB / Estadio IV (de acuerdo con la versión 7 del Manual de Estadificación en Oncología Torácica de la Asociación Internacional para el Estudio del Cáncer de Pulmón) o enfermedad recurrente después de radioterapia o resección quirúrgica.
    3. Los sujetos deben haber experimentado recurrencia o progresión de la enfermedad durante o después de un régimen previo de quimioterapia en pareja de fármacos con platino para enfermedad avanzada o metastásica
    4. Los sujetos deben tener enfermedad medible por TC o RM según los criterios RECIST 1.1;
    5. Estado funcional ? 1 del Eastern Cooperative Oncology Group (ECOG)
    6. Debe estar disponible un bloque de tejido tumoral fijado en formol, incluido en parafina (FFIP) o preparaciones no teñidas de muestra tumoral (de archivo o reciente) para la evaluación de biomarcadores, como se describe en la Sección 5.4.2. Antes de la aleatorización, el laboratorio central debe haber recibido las muestras. La biopsia debe ser excisional, incisional o de aguja gruesa. La aspiración con aguja fina es insuficiente
    E.4Principal exclusion criteria
    1) Subjects with active CNS metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ?10mg daily prednisone (or equivalent)
    2) Subjects with carcinomatous meningitis.
    3) Subjects with active, known or suspected autoimmune disease, or subjects with interstitial lung disease.
    4) Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization.
    4) Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    5) Prior treatment on the first line study CA184104 first line NSCLC study
    6) Prior treatment with docetaxel
    7) Treatment with any investigational agent within 28 days of first administration of study treatment.
    o Se excluye a los sujetos con metástasis activas en el SNC. Los sujetos son elegibles si las metástasis del SNC se tratan adecuadamente y los sujetos han vuelto neurológicamente a la situación basal (excepto los signos o síntomas residuales relacionados con el tratamiento del SNC) durante al menos 2 semanas antes del reclutamiento. Además, los sujetos no deben estar recibiendo corticosteroides o deben estar recibiendo una dosis estable o decreciente de ?10 mg al día de prednisona (o equivalente).
    o Sujetos con meningitis carcinomatosa
    o Sujetos con enfermedad autoinmunitaria activa, conocida o de sospecha. Se permite reclutar a sujetos con vitiligo, diabetes mellitus de tipo I, hipotiroidismo residual debido a tiroiditis autoinmunitaria que sólo precisa sustitución hormonal o problemas que no se espera que recurran en ausencia de un desencadenante externo.
    o Se permiten la inclusión de sujetos con un problema que precise tratamiento sistémico con corticosteroides u otros medicamentos inmunosupresores al menos 14 días antes de la primera dosis del tratamiento del estudio
    o Tratamiento previo con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti-CTLA-4 (incluido ipilimumab o cualquier otro anticuerpo o fármaco que se dirija específicamente a las vías de coestimulación o control de los linfocitos T).
    o Tratamiento previo en el estudio de primera línea CA184104
    o Tratamiento previo con docetaxel
    o Tratamiento con cualquier agente experimental dentro de los 28 días previos a la primera administración del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate, Overall Survival
    Tasa de respuesta objetiva, la supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.5.2Secondary end point(s)
    1. To compare the progression-free survival (PFS) of BMS-936558 versus docetaxel
    2. To evaluate clinical benefit in terms of ORR and OS of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups
    3. To evaluate durability of and time to objective response in BMS-936558 and docetaxel groups
    4. To evaluate the proportion of subjects exhibiting disease-related symptom progression, as measured by LCSS, in BMS-936558 and docetaxel groups
    ?Comparar la supervivencia libre de progresión (SLP) con BMS-936558 frente a docetaxel
    ?Evaluar el beneficio clínico en términos de TRO y SG de BMS-936558 frente a docetaxel en los subgrupos según expresión de proteína, PD-L1 + frente a PD-L1-.
    ?Evaluar la durabilidad de y el tiempo hasta la respuesta objetiva en los grupos de BMS-936558 y docetaxel.
    ?Evaluar la proporción de sujetos que muestran progresión de los síntomas relacionados con la enfermedad, medida con la LCSS, en los grupos de BMS-936558 y docetaxel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker Assessments, Immunogenicity Assessments, Outcomes Research Assessments: Lung Cancer Symptom Scale (LCSS), and EuroPRO Group?s EQ-5D.
    .Evaluar biomarcadores
    ?Evaluar el efecto de la variación natural que tienen los polimorfismos de nucleótidos únicos (SNP) ?Caracterizar la farmacocinética de BMS-936558 ?Caracterizar la inmunogenia de BMS-936558
    ?Evaluar el estado de salud mediante el Índice EQ-5D
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Austria
    Brazil
    Canada
    Chile
    Czech Republic
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Ireland
    Italy
    Mexico
    Netherlands
    Norway
    Peru
    Poland
    Romania
    Russian Federation
    Singapore
    South Africa
    Spain
    Turkey
    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
    This study will end when analysis of survival is complete. All subjects will be followed for overall survival every 3 months until death, lost to follow-up, or withdrawal of study consent. The duration of study will be approximately 2 years (24 months).
    Este estudio terminará r cuando el análisis de la supervivencia se ha completado. Todos los sujetos estaran en seguimiento para la supervivencia general cada 3 meses hasta la muerte, la pérdida en el seguimiento, o la revocación del consentimiento de estudio. La duración del estudio será de aproximadamente 2 años (24 meses).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 320
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics
    committee, or through another mechanism at the discretion of the sponsor. See also Protocol, section 3.2 for more details.
    A la conclusión del estudio, los sujetos que siguan demostraran beneficio clínico y serán elegible para recibir el medicamento del estudio. El fármaco de estudio será proporcionado a través de una extensión del estudio, un estudio de seguimiento que requiere la aprobación por AEMPS y CEICS
    o a través de otro mecanismo, a discreción del patrocinador. Véase también el Protocolo, la sección 3.2 para más detalles.
    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 Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-17
    P. End of Trial
    P.End of Trial StatusOngoing
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