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    The EU Clinical Trials Register currently displays   39177   clinical trials with a EudraCT protocol, of which   6419   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-001168-35
    Sponsor's Protocol Code Number:A4021018
    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:2008-05-06
    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 number2008-001168-35
    A.3Full title of the trial
    ENSAYO ALEATORIZADO, ABIERTO, EN FASE 3 DE ERLOTINIB SOLO O EN COMBINACION CON CP-751,871 EN PACIENTES CON CANCER DE PULMON NO MICROCITICO AVANZADO DE HISTOLOGIA NO ADENOCARCINOMATOSA.
    A.4.1Sponsor's protocol code numberA4021018
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCP-751,871
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCP-751,871
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib hydrochloride
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 183321-74-6
    D.3.9.3Other descriptive nameErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib hydrochloride
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 183321-74-6
    D.3.9.3Other descriptive nameErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP 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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib hydrochloride
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 183321-74-6
    D.3.9.3Other descriptive nameErlotinib
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    CPNM avanzado de histología no adenocarcinomatosa.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia global (SG) en pacientes con CPNM avanzado con histología no adenocarcinomatosa tratados con erlotinib solo (grupo B) o con CP 751,871 más erlotinib (grupo A). Los pacientes del grupo B podrán haber recibido monoterapia con CP 751,871 tras haber presentado progresión con erlotinib solo.
    E.2.2Secondary objectives of the trial
    •Comparar la supervivencia sin progresión (SSP) en pacientes con CPNM avanzado con histología no adenocarcinomatosa tratados con erlotinib solo (grupo B) o con CP 751,871 más erlotinib (grupo A).
    •Evaluar la seguridad y la tolerabilidad de múltiples dosis de CP 751,871;
    •Evaluar la eficacia de CP 751,871 mediante la TRO;
    •Obtener datos FC de CP 751,871 para futuros metaanálisis de FC poblacional;
    •Controlar la aparición de anticuerpos contra el fármaco en respuesta a CP 751,871;
    •Evaluar la presencia de células tumorales circulantes (CTCs) que expresen el IGF IR;
    •Evaluar las diferencias en las utilidades del estado de salud, mediante el cuestionario EQ 5D.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones o mujeres de edad > 18 años
    2. Carcinoma pulmonar no microcítico demostrado por histología o citología, con una histología primaria de carcinoma de células escamosas, macrocítico o adenoescamoso y sus variantes (Apéndice 11), con metástasis (estadio IV o enfermedad recurrente) o localmente avanzado (estadio IIIB) con derrame pleural maligno.
    3. Pacientes en quienes erlotinib sea una opción de tratamiento razonable. El paciente deberá haber recibido tratamiento previo para la enfermedad avanzada, consistente al menos en una pauta de combinación basada en platino. No obstante, los pacientes de edad igual o superior a 70 años podrán haber recibido monoterapia en al menos una ocasión. En los países en que el uso y disponibilidad de docetaxel o pemetrexed sean el estándar asistencial, los pacientes también deberán haber recibido tratamiento previo con uno o ambos, o presentar una contraindicación significativa a uno o a ambos.
    4. Al menos 1 lesión mensurable, según los RECIST. Todas las lesiones diana deberán tener un diámetro unidimensional de 2 cm como mínimo (se acepta que mida 1 cm en las TC helicoidales, si el algoritmo de reconstrucción es de 0,5 cm). Las mediciones/evaluaciones basales deberán estar realizadas en las 4 semanas previas a la aleatorización y se harán en el centro de investigación participante.
    5. Estado funcional (ECOG) de 0-2.
    6. Deberán haber transcurrido 2 semanas como mínimo desde el último ciclo de tratamiento sistémico hasta la inclusión. Los pacientes deberán haber alcanzado el grado < 1 de los CTCAE del NCI v 3.0 en todos los efectos tóxicos agudos (excepto aquellos de grado 1 que el promotor y el investigador no consideren riesgos para la seguridad), o el investigador deberá considerar que se trata de toxicidad irreversible.
    7. Deberá haber transcurrido una semana como mínimo desde la última sesión de radioterapia. Los pacientes se habrán recuperado de todos los efectos secundarios agudos de la radioterapia.
    8. El paciente deberá presentar las funciones hematológica, renal y hepática adecuadas, definidas por: hemoglobina > 9 g/dl, neutrófilos > 1.000/mm3, plaquetas > 50.000/mm3, creatinina < 2 mg/ml y AST (SGOT) y/o ALT (SGPT) < 5 x LSN (límite superior normal).
    9. Disposición y capacidad de cumplir las visitas programadas, los planes de tratamiento, las pruebas analíticas y otros procedimientos del estudio, entre ellos, la aportación de extensiones o cortes incluidos en parafina para el diagnóstico y la determinación de los resultados comunicados por los pacientes.
    10. Prueba de embarazo negativa dentro de la semana anterior a la dosis inicial de CP-751,871 en las mujeres con potencial fértil. Las mujeres deben estar esterilizadas quirúrgicamente o ser posmenopáusicas, o deben acceder a emplear un método anticonceptivo de doble barrera durante el periodo de tratamiento y hasta 5 meses después de la última dosis de medicación del estudio. Se consideran anticonceptivos de doble barrera el preservativo más espermicida en combinación con un preservativo femenino, diafragma o tapón cervical, o el preservativo más espermicida en combinación con un dispositivo intrauterino. Dentro de estos límites, la elección del método anticonceptivo específico se deja a la discreción del sujeto o del investigador principal.
    11. Comprensión del consentimiento informado por escrito, voluntario, firmado y fechado.
    E.4Principal exclusion criteria
    1. 1. Histología del CPNM primario no incluida en el criterio de inclusión nº 1. CPNM primario de tipo adenocarcinoma y sus subtipos: acinar, papilar, bronquioalveolar, sólido, fetal, mucinoso, en anillo de sello y de células claras, o con histología mixta de todos estos tipos. Histología del CPNM desconocida o no especificada (sin más detalles).
    2. Tratamiento previo con erlotinib.
    3. Tratamiento experimental previo basado en anti IGF IR. Otros tratamientos experimentales (dirigidos o vacunas), a menos que el investigador y el promotor acuerden otra cosa, necesitarán un período de lavado de 2 semanas antes de la inclusión.
    4. Metástasis cerebrales sintomáticas. Metástasis cerebrales estables durante menos de 2 semanas antes de la administración, o que requieren corticoterapia o con síntomas clínicos. Síntomas clínicos indicativos de metástasis cerebral nueva en las 2 semanas previas a la inclusión, a menos que se descarte la presencia de metástasis cerebrales nuevas por TC o RM.
    5. Cirugía mayor en las 3 semanas previas a la inclusión en el estudio o recuperación incompleta de los efectos secundarios de procedimientos anteriores.
    6. Neoplasias malignas anteriores (menos de 3 años antes) o actuales y que no sean carcinoma cervical uterino in situ ni carcinoma de células basales o epidermoide de la piel que hayan recibido tratamiento curativo.
    7. Diabetes no controlada (definida por una Hb A1c > 8 %).
    8. Cardiopatía activa significativa, como: hipertensión no controlada (es decir, presión arterial sistólica > 180 mm Hg, presión arterial diastólica > 95 mm Hg), angina inestable, trombosis venosa profunda, embolia pulmonar, accidente cerebrovascular, valvulopatía, insuficiencia cardíaca congestiva, infarto de miocardio (en los 6 meses previos) o arritmias cardíacas graves.
    9. Cualquier otro trastorno médico o infección activa graves no controlados que mermarían la capacidad para recibir el tratamiento del estudio, en opinión del investigador.
    10. Pacientes que reciban corticoterapia sistémica inmunosupresora en dosis altas (>100 mg de prednisona al día o > 40 mg de dexametasona al día) en las 2 semanas previas a la inclusión. Se permite el tratamiento previo con esteroides en dosis moderadas a elevadas, pero se suspenderá en el momento de inclusión. Se permite el uso de esteroides tópicos, esteroides inhalados y esteroides en dosis bajas en el momento de la aleatorización (p. ej., cortisona 30 mg/día, prednisona 5 mg/día).
    11. Demencia o alteración importante del estado mental que limitaría la comprensión o la concesión del consentimiento informado y el cumplimiento de los requisitos de este protocolo.
    12. Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Criterio Primario de Valoración: Supervivencia global.
    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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Study group not treated with test IMP only Erlotinib
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 EEA64
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months5
    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 months5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 600
    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)
    Los pacientes podrán recibir tratamiento durante un año como máximo, salvo que presenten toxicidad intolerable. Si se demuestran la seguridad, la tolerabilidad y el beneficio clínico del tratamiento, se podrá seguir administrando más de 1 año, previo acuerdo con el investigador y el promotor. Los pacientes de los 2 grupos podrán recibir el MTS durante 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 Decision2008-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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