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    Summary
    EudraCT Number:2011-001076-18
    Sponsor's Protocol Code Number:26481585LYM2001
    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:2011-07-26
    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 number2011-001076-18
    A.3Full title of the trial
    A Phase 2, Randomized, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 at Two Dose Levels in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
    Estudio fase 2, aleatorizado, abierto, multicéntrico del inhibidor de la Histona Deacetilasa (iHDAC) JNJ-26481585 a dos niveles de dosis en sujetos con linfoma cutáneo de células T en estadío Ib-IVa previamente tratado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma (CTCL)
    Un estudio del inhibidor de la Histona Deacetilasa (iHDAC) JNJ-26481585 en pacientes con linfoma cutáneo de células T (LCCT) en estadío Ib-IVa previamente tratado.
    A.4.1Sponsor's protocol code number26481585LYM2001
    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 SponsorJanssen-Cilag International NV
    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 supportJanssen Research & Development
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV- Archimdesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number..+ 31(0)715242166.
    B.5.5Fax number..+ 31(0)715242110.
    B.5.6E-mailClinicalTrialsEU@its.jnj.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.3.2Product code JNJ-26481585
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeJNJ-26481585
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    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 Ib-IVa Cutaneous T-cell Lymphoma
    Linfoma cutáneo de células T en estadío Ib-IVa
    E.1.1.1Medical condition in easily understood language
    Cutaneous T-cell Lymphoma (CTCL)
    Linfoma cutáneo de células T (LCCT)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10011677
    E.1.2Term Cutaneous T-cell lymphoma
    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 is to determine the overall cutaneous response rate (RR) based on the modified Severity Weighted Assessment Tool (mSWAT) criteria.
    El objetivo principal es determinar la tasa de respuesta (TR) global a nivel cutáneo basada en los criterios de la ?Severity Weighted Assessment Tool modificado? (mSWAT).
    E.2.2Secondary objectives of the trial
    * To determine the overall global RR based on consensus global response score for mycosis fungoides (MF) / Sézary Syndrome (SS) (mSWAT + nodes/viscera + blood)
    * To evaluate the safety profile of JNJ-26481585
    * To determine the duration of response (DOR)
    * To estimate progression free survival (PFS)
    * To estimate 1-year overall survival rate
    * To explore the effect of JNJ-26481585 on symptoms and capacity to function [patient reported outcomes (PROs)]
    * To assess pharmacodynamic markers of JNJ-26481585 activity in tumor biopsies and surrogate tissues
    * To explore biomarkers predictive of response to JNJ-26481585
    * To explore the population pharmacokinetics of JNJ-26481585
    ?Determinar la TR global basada en la puntuación de la respuesta global consensuada para la micosis fungoide (MF) / síndrome de Sézary (SS) (mSWAT + ganglios/órganos + sangre).
    ?Evaluar el perfil de seguridad de JNJ-26481585
    ?Determinar la duración de la respuesta (DR)
    ?Calcular la supervivencia sin progresión (SSP)
    ?Calcular la supervivencia global a 1 año.
    ?Explorar el efecto de JNJ-26481585 sobre los síntomas y la capacidad funcional [resultados comunicados por los pacientes (RCP)].
    ?Evaluar marcadores farmacodinámicos de la actividad del JNJ-26481585 en biopsias tumorales y tejidos circundantes.
    ?Explorar los biomarcadores predictivos de la respuesta a JNJ-26481585.
    ?Explorar la farmacocinética poblacional de JNJ-26481585.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place
    2. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
    3. Histopathologically confirmed CTCL, either mycosis fungoides or Sézary syndrome Stage Ib-IVa
    4. Relapsed or refractory disease following at least 1 prior systemic therapy for CTCL. PUVA is considered skin-directed therapy and not systemic therapy. Subjects must have recovered from toxicity related to prior systemic therapy after at least 3 weeks wash-out period.
    5. Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 4 weeks
    6. Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) ? 1 cm in the longest diameter
    7. Adequate liver function as determined by serum total bilirubin levels ?1.5 x upper limit of normal (ULN), and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ?2.5 x ULN
    8. Adequate bone marrow function, as determined by an absolute neutrophil count (ANC)?1200/mm3 (or ?1.2x10 to the 9th/L); a platelet count ?100,000/mm3 (or ?100x10 to the 9th/L) and
    a hemoglobin level greater than 9 g/dL (or?90 g/L), in the absence of transfusion requirements or cytokine support for 7 days prior to enrolling on the study
    9. Serum potassium, calcium (corrected for albumin level), magnesium must be within institutional normal limits
    10. LVEF within institutional normal limits, as determined by MUGA or echocardiography
    11. Adequate renal function as determined by serum creatinine levels ?1.5xULN
    12. If a woman, before study entry she must be
    * postmenopausal (> 45 years of age with amenorrhea for at least 18 months)
    * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
    * if heterosexually active, practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization) before enrollment, throughout the study, and up to 6 months after stopping study drug
    13. Negative pregnancy test (urine or serum ?-hCG) at Screening (applicable to women of child bearing potential who are sexually active) at most 7 days prior to starting treatment
    14. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug
    15. Subjects must have signed an informed consent document indicating that they understand the purpose and procedures required, and are willing to participate in the study
    16. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a
    subject from participation in the clinical study
    1.Tener dieciocho años de edad como mínimo o la edad legal de consentimiento en la jurisdicción en la que tenga lugar el estudio.
    2.Puntuación entre 0 y 2 en la evaluación del estado funcional mediante la escala ?Eastern Cooperative Oncology Group? (ECOG) (Apéndice 1).
    3.LCCT confirmado histopatológicamente, ya sea micosis fungoide o síndrome de Sézary, en estadío Ib-IVa (Apéndice 2).
    4.Enfermedad recidivante o resistente después de al menos un tratamiento sistémico previo para el LCCT. El PUVA se considera un tratamiento dirigido a la piel y no un tratamiento sistémico. Los sujetos deben haberse recuperado de la toxicidad relacionada con el tratamiento sistémico previo después de un período de lavado de al menos 3 semanas.
    5.Pauta antiprurito estable (corticosteroides tópicos o antihistamínicos) en las 4 semanas previas.
    6.Enfermedad medible con al menos 1 lesión cutánea (manchas, placas o tumor) ?1 cm en su diámetro mayor.
    7.Función hepática adecuada determinada mediante una concentración sérica de bilirrubina total ?1,5 veces el límite superior de la normalidad (LSN) y concentración sérica de alanina aminotransferasa (ALT) y de aspartato aminotransferasa (AST) ?2,5 veces el LSN.
    8.Función suficiente de la médula ósea, determinada por un recuento absoluto de neutrófilos (RAN) ?1.200/mm3 (o ?1,2 x 109/l), un recuento de plaquetas ?100.000/mm3 (o ?100 x 109/l) y una concentración de hemoglobina superior a 9 g/dl (?90 g/l) sin necesidad de transfusión ni de apoyo con citocinas durante los 7 días previos a la incorporación al estudio.
    9.El potasio, el calcio (corregido por la albúmina) y el magnesio séricos deben estar dentro de los límites normales del centro.
    10.FEVI en el intervalo normal del centro, según lo determinado mediante MUGA o ecocardiograma.
    11.Función renal adecuada determinada por una concentración de creatinina en suero ?1,5 x LSN
    12.Si es mujer, antes de la entrada en el estudio debe:
    ?ser posmenopáusica (>45 años de edad con amenorrea durante al menos 18 meses);
    ?estar esterilizada quirúrgicamente (histerectomía u ovariectomía bilateral o ligadura de trompas o infértil por otra causa);
    ?si mantiene relaciones heterosexuales, debera utilizar un método anticonceptivo eficaz (por ejemplo, anticonceptivos orales con receta, anticonceptivos inyectables, parche anticonceptivo, dispositivo intrauterino, método de doble barrera o esterilización de la pareja masculina) antes de la inclusión, durante el estudio y hasta 6 meses después de suspender el fármaco del estudio.
    13.Prueba de embarazo negativa (?-/hCG en orina o suero) en la selección (aplicable a las mujeres en edad fértil que sean sexualmente activas) como máximo 7 días antes del inicio del tratamiento.
    14.Los varones deberán comprometerse a utilizar un método anticonceptivo de doble barrera y a no donar semen durante el estudio y durante 6 meses después de recibir la última dosis del fármaco del estudio.
    15.Los sujetos deberán haber firmado un documento de consentimiento informado que indique que entienden el objetivo del estudio y los procedimientos que éste exige y que están dispuestos a participar en él.
    16.Para participar en la parte de farmacogenómica opcional de este estudio, los sujetos deberán haber firmado el documento de consentimiento informado para la investigación farmacogenómica indicando su voluntad de participar en ella (si lo permite la normativa local). La negativa a otorgar el consentimiento para esta parte del estudio no excluirá al sujeto de participar en el estudio clínico.
    E.4Principal exclusion criteria
    1. Prior histone-deacetylase inhibitor therapy for CTCL
    2. Concurrent systemic corticosteroid dose > 10 mg/day of prednisone or equivalent (stable use of ?10 mg/day of prednisone for ?1 month before study entry is allowed)
    3. Major surgery or radiotherapy within 3 weeks before study drug administration. Focal radiotherapy for local disease control is allowed. Subjects must have recovered from prior radiotherapy or surgery related toxicity
    4. Other malignancy within past 5 years. Exceptions include: basal or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Fédération Internationale de Gynécologie et d?Obstétrique Stage 1 carcinoma of the cervix, prostate intraepithelial neoplasia and biochemical relapse free ? 3 years
    5. Unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure New York Heart Association Class II-IV; known presence of dilated, hypertrophic, or restrictive cardiomyopathy; or any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the subject at an unacceptably increased risk with study drug
    6. History of any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, atrial fibrillation, cardiac arrest, Mobitz II second degree heart block, or third degree heart block; QTc at Screening > 450 ms in males / > 470 ms in females; family history of short QT syndrome, long QT syndrome; obligate use of a
    cardiac pacemaker. Use of medications that may cause Torsades de Pointes; any of these medications must be discontinued for at least 5 half-lives prior to the first dose of JNJ-26481585.
    7. Use of potent inhibitors of CYP3A4/A5
    8. Known HIV/AIDS
    9. Uncontrolled concurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing clinically significant active infection requiring systemic antibiotics, or psychiatric illness/social situation that may potentially impair subject?s compliance with study procedures
    10. Planned major surgery during study period
    11. Inadequate gastrointestinal absorption status (status post-gastrectomy, upper gastrointestinal tract obstruction, inability to swallow)
    12. Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria
    13. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study, or prevent the subject from meeting or performing study requirements
    14. Pregnant or breast-feeding
    NOTE: Investigators should ensure that all study enrollment criteria have been met at Screening. If a subject's status changes (including laboratory results) after Screening but before first dose of study drug is given such that they now meet an exclusion criterion, they should be excluded from participation in the study.
    1.Tratamiento previo del LCCT con inhibidores de la histona deacetilasa.
    2.Administración concomitante de corticosteroides sistémicos >10 mg/día de prednisona o equivalente (se permite el uso estable de ?10 mg/día de prednisona durante ?1 mes antes de la entrada en el estudio).
    3.Cirugía mayor o radioterapia en las 3 semanas previas a la administración del fármaco del estudio. Se permite la radioterapia focal para el control local de la enfermedad. Los sujetos deberán haberse recuperado de la toxicidad relacionada con radioterapia o cirugía previas.
    4.Otra enfermedad maligna en los últimos 5 años. Excepciones: carcinoma basocelular o espinocelular no metastásico de la piel, carcinoma cervicouterino in situ o cervicouterino en estadío 1 según la Fédération Internationale de Gynécologie et d?Obstétrique, neoplasia intraepitelial prostática sin recidiva bioquímica ?3 años.
    5.Angina inestable o infarto de miocardio en los 12 meses anteriores; insuficiencia cardiaca congestiva de clase II-IV de la New York Heart Association (véase el apéndice 4); presencia conocida de miocardiopatía dilatada, hipertrófica o restrictiva; u otra alteración cardíaca que, en opinión del investigador, el monitor médico o un cardiólogo consultor, pueda exponer al sujeto a un aumento inaceptable del riesgo con el fármaco del estudio.
    6.Algún ntecedente de: taquicardia ventricular mantenida, fibrilación ventricular, taquicardia helicoidal, fibrilación auricular, parada cardíaca, bloqueo cardíaco de segundo grado Mobitz II o bloqueo de tercer grado; QTc en la selección >450 ms en los varones o >470 ms en las mujeres; antecedentes familiares de síndrome del QT corto, síndrome del QT largo; uso obligado de un marcapasos cardíaco. Uso de medicamentos que pueden causar taquicardia helicoidal (apéndice 5); la administración de estos fármacos debe interrumpirse durante al menos cinco semividas antes de la primera dosis de JNJ-26481585.
    7.Uso de inhibidores potentes de la CYP3A4/A5 (véase el apartado 8.1).
    8.VIH/SIDA conocido.
    9.Enfermedad concomitante no controlada como, entre otras, hipertensión o diabetes mal controladas, infección activa de importancia clínica con necesidad de antibióticos sistémicos o enfermedad psiquiátrica o situación social que puedan deteriorar el cumplimiento terapéutico de los procedimientos del estudio por parte del paciente.
    10.Intervención quirúrgica mayor programada durante el período de estudio.
    11.Absorción digestiva insuficiente (posgastrectomía, obstrucción digestiva alta, incapacidad para tragar).
    12.Necesidad de factores de crecimiento hematopoyéticos o transfusión de hemoderivados para cumplir los criterios de elegibilidad.
    13.Cualquier trastorno que, en opinión del investigador, comprometería el bienestar del sujeto o el estudio o impediría que el sujeto cumpliera o realizara los requisitos del estudio.
    14.Embarazo o lactancia
    NOTA: los investigadores deberán asegurarse de que todos los criterios de participación en el estudio se cumplen en el momento de la visita de selección. Si el estado de un sujeto cambia (incluidos los resultados analíticos) después de la visita de selección pero antes de la primera dosis de la medicación del estudio de modo que cumpla un criterio de exclusión, se excluirá al sujeto de la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the overall cutaneous RR (as determined by mSWAT criteria), defined as the proportion of evaluable subjects who achieve a CCR (complete disappearance of all cutaneous disease) or PR (? 50% reduction in mSWAT score compared to baseline).
    El criterio de valoración principal de la eficacia es la TR global a nivel cutáneo, definida como la proporción de sujetos evaluables que logren una respuesta clínica completa (RCC) o parcial (RP) según el mSWAT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 weeks
    Cada 6 semanas
    E.5.2Secondary end point(s)
    * Overall global RR, defined as the proportion of subjects who achieve CR or PR based on the consensus global response score for MF/SS [defined as the total score of tumor, lymph nodes, metastasis, blood (TNMB) staging, ie, cutaneous disease, lymph nodes, viscera and
    blood]
    * PFS, defined as the interval between the date of randomization and the date of disease progression or death from any cause, whichever occurs first
    * 1-year overall survival rate, defined as the Kaplan-Meier (KM) estimate of the proportion of subjects surviving at 1 year post-randomization
    * DOR for subjects achieving a CR or PR, defined as the date from the first documentation of CR or PR until the date of first documentation of PD, or death from any cause
    * The EORTC QLC C30 and the Pruritus Intensity Assessment Questionnaire scale scores
    * Pharmacodynamic markers of JNJ-26481585 response in tumor biopsies and surrogate tissues
    * Biomarkers predictive of response to JNJ-26481585 through comparison of expression of tumor; specific markers in responders and non-responders
    * Population pharmacokinetics of JNJ-26481585
    ?TR global total, definida como proporción de sujetos que alcanzan la RC o la RP según la escala de respuesta global de consenso para MF/SS [definida como la puntuación total del estadío de la clasificación TGMS (tumor, ganglios, metástasis, sangre), es decir, piel, ganglios linfáticos, vísceras y sangre (apartado 9.2.1.5)].
    ?SSP, definida como el intervalo entre la fecha de aleatorización y la fecha de progresión de la enfermedad o la muerte por cualquier causa, lo que ocurra antes.
    ?Supervivencia global a 1 año, definida mediante el cálculo de Kaplan-Meier (KM) de la proporción de sujetos que sobreviven 1 año después de la aleatorización.
    ?DR en los sujetos que logren una RC o RP, definida como el intervalo entre la fecha de la primera documentación de RC o RP y la fecha de la primera documentación de PE o muerte por cualquier causa.
    ?QLC C30 de la EORTC y puntuaciones del cuestionario de evaluación de la intensidad del prurito.
    ?Marcadores farmacodinámicos de respuesta a JNJ-26481585 en las biopsias tumorales y tejidos circundantes..
    ?Marcadores biológicos predictivos de la respuesta a JNJ-26481585 mediante la comparación de la expresión del tumor; marcadores específicos en sujetos con y sin respuesta.
    ?Farmacocinética poblacional de JNJ-26481585.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 weeks
    cada 12 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory Biomarkers Evaluations
    Evaluación de 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    2 niveles de dosis
    2 dose levels study
    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
    2 niveles de dosis
    2 dose levels study
    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 EEA16
    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
    France
    Germany
    Italy
    Portugal
    Spain
    United Kingdom
    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
    The Study is considered completed with the last study assessment for the last subject participating in the study.
    El estudio se considerará finalizado con la última evaluación del estudio del último sujeto participante en el mismo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 42
    F.4.2.2In the whole clinical trial 46
    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)
    Subjects may enter a Long-term Extension Phase and continue to receive study treatment until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective drugs that the subject may receive, or treating physician advice). The Long-term Extension Phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis.
    Los pacientes pueden entrar en una fase de extensión a largo plazo y continuar recibiendo el tratamiento del estudio hasta que se cumpla un motivo de retirada (progresión de la enfermedad, toxicidad, disponibilidad de otros medicamentos eficaces que el sujeto pueda recibir o consejo del médico responsable del tratamiento). La fase de extensión a largo plazo continuará durante un máximo de 2 años después del punto de corte clínico para el análisis principal.
    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 Decision2011-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-22
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