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    Summary
    EudraCT Number:2015-003359-23
    Sponsor's Protocol Code Number:GEM-PEMBRESID
    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:2015-11-05
    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 number2015-003359-23
    A.3Full title of the trial
    Clinical Trial of Phase II, Open Label, Multicenter, of the monoclonal antibody anti-PD1 Pembrolizumab (MK-3475) as consolidation therapy in patients with multiple myeloma with residual disease after treatment.
    Ensayo clínico de fase II, abierto, multicéntrico, del anticuerpo monoclonal anti-PD1 pembrolizumab (MK-3475) como terapia de consolidación para pacientes con mieloma múltiple en los que persista enfermedad residual tras tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in exploration phase, to suministrate monoclonal antibody anti-PD1 Pembrolizumab (MK-3475)as consolidation therapy in patients with multiple myeloma with residual disease after treatment.
    Ensayo clínico en fase de exploración, que administra anticuerpo monoclonal anti-PD1 pembrolizumab (MK-3475) como terapia de consolidación a pacientes a los que les persista la enfermedad residual tras el tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    GEM-PEMBRESID
    GEM-PEMBRESID
    A.4.1Sponsor's protocol code numberGEM-PEMBRESID
    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 SponsorFundación Pethema
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme de España S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pethema
    B.5.2Functional name of contact pointFundación Pethema
    B.5.3 Address:
    B.5.3.1Street AddressHospital Clinico San Carlos, Servicio Hematorologia C/ Profesor Martín Lagos s/n.
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913303312
    B.5.5Fax number+34913303311
    B.5.6E-mailpethema@pethema.es
    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 Yes
    D.2.1.1.1Trade name KEYTRUDA 50 mg polvo
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Limited
    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 nameKEYTRUDA 50 mg polvo
    D.3.2Product code SCH900475; MK-3475
    D.3.4Pharmaceutical form 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeSCH 900475; MK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB91641
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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.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
    Patients with multiple myeloma with residual disease after treatment
    Pacientes con mieloma múltiple en los que persista enfermedad residual tras tratamiento
    E.1.1.1Medical condition in easily understood language
    Patients with multiple myeloma with residual disease after treatment
    Pacientes con mieloma múltiple en los que persista enfermedad residual tras tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of MK-3475 administered as consolidation therapy in Multiple Myeloma (MM) patients with residual disease after a previous treatment administered as 1st or 2nd line of therapy in terms of upgrade of the response
    - Evaluar la eficacia de MK-3475 administrado como terapia de consolidación en pacientes con mieloma múltiple (MM) con enfermedad residual tras un tratamiento previo administrado como primera o segunda línea de tratamiento en términos de mejora de respuesta
    E.2.2Secondary objectives of the trial
    - To assess the safety of MK-3475 in patients with MM with persistent residual disease as determined by the incidence of clinical and laboratory toxicities.
    - To analyze the efficacy of MK-3475 administered as consolidation therapy in MM patients with residual disease after a previous treatment, in terms of achievement of negative MRD.
    - To analyze pharmacodynamics changes associated with MK-3475 treatment due to PD1/PDL1 blockade in lymphocytes and correlate them with the response obtained.
    - Valorar la seguridad de MK-3475 en pacientes con MM con enfermedad residual persistente, determinada por la incidencia de toxicidades clínicas y de laboratorio.
    - Analizar la eficacia de MK-3475 administrado como terapia de consolidación en pacientes con MM con enfermedad residual tras un tratamiento previo, en términos de logro de una MRD negativa.
    - Analizar los cambios farmacodinámicos asociados al tratamiento con MK-3475 debidos al bloqueo de PD1/PDL1 en los linfocitos, y correlacionarlos con la respuesta obtenida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥ 18 years.
    2.Performance status (ECOG) ≤ 2.
    3.Patient is, in the Investigators opinion, willing and able to comply with the protocol requirements.
    4.Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    5.Patients previously diagnosed with MM according to the IMWG Criteria (Blood 2011) who are in good response (≥ VGPR) but with persistent residual disease after the end of any therapy administered for a limited duration of time either as 1st or 2nd line of therapy.
    Persistent disease is defined by either the presence of an M-Component by electrophoresis, positive immunofixation, abnormal FLC ratio or identification of pathological plasma cells by flow cytometry.
    6.At least 2 months for any non-transplant therapy or 3 months after ASCT, must elapse from the last dose of the previous treatment before being eligible to be included in the trial.
    7.Response must be confirmed to be stable between the end of the previous therapy and the initiation of the trial (see the time that must elapse in the previous criteria). Stable is defined as:
    -No change in response according to the IMWG Criteria between these determinations.
    -No evidence of increase or decrease (> 25%) in M-component, provided the variation is > 0.5 mg/dl.
    -No evidence of increase or decrease (> 25%) of the involved FLC, provided the ratio is abnormal and the absolute change is > 10 mg/dL.
    -No evidence of increase or decrease (> 50%) of the percentage of pathological plasma cells by flow cytometry in the bone marrow provided the variation is > 0.5%.
    -No positivization or negativization of the electrophoresis or IFE between these determinations.

    In case of doubt, another determination separated at least 1 month after the last one is required to confirm the stability of the response, and this must be discussed with the DMC, prior to be eligible.
    1. Edad ≥ 18 años.
    2. Capacidad funcional (ECOG) ≤ 2.
    3. En opinión del investigador, el paciente acepta cumplir los requisitos del protocolo y es capaz de hacerlo.
    4. El paciente ha otorgado voluntariamente un consentimiento informado por escrito antes de cualquier intervención relacionada con el estudio que no forme parte de la práctica clínica habitual, y es conocedor de que puede retirar el consentimiento en cualquier momento sin que eso perjudique su atención médica futura.
    5. Pacientes diagnosticados previamente de MM según los criterios del IMWG (Blood, 2011) que hayan logrado una buena respuesta (≥ VGPR) pero presenten enfermedad residual persistente tras la finalización de cualquier tratamiento administrado durante un tiempo limitado como primera o segunda línea de terapia.
    La enfermedad persistente se define por la presencia de cualquiera de los siguientes datos: componente M en la electroforesis, inmunofijación positiva, cociente de CLL anómalo o identificación de células plasmáticas patológicas mediante citometría de flujo.
    6. Deben haber transcurrido al menos 3 meses tras un TAPH o 2 meses desde la última dosis del tratamiento previo en caso de terapias distintas de trasplante, antes del inicio del tratamiento del ensayo.
    7. Hay que confirmar que la respuesta es estable entre el final de la terapia previa y el inicio del tratamiento del ensayo (véase el tiempo que debe transcurrir en los criterios anteriores).
    Estable se define como:
    -Sin cambios en la respuesta según los criterios del IMWG entre estas determinaciones.
    -No evidencia de incremento o reducción (> 25%) del componente M, siempre que la variación sea > 0,5 mg/dl.
    -No evidencia de incremento o reducción (> 25%) de las CLL afectadas, siempre que el cociente sea anómalo y la variación absoluta resulte > 10 mg/dl.
    -No evidencia de incremento o reducción (> 50%) del porcentaje de células plasmáticas patológicas mediante citometría de flujo en la médula ósea, siempre que la variación sea > 0,5%.
    -No hay positivización ni negativización de la electroforesis o la IFE entre estas determinaciones.
    En caso de duda, será necesaria otra determinación realizada al menos 1 mes después de la última para confirmar la estabilidad de la respuesta; esto debe consultarse con el CMD antes de que el paciente pueda ser candidato a participar en el estudio.
    E.4Principal exclusion criteria
    1.Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or other antibody or drug specifically targeting T cell co-stimulation).

    2.Known hypersensitivity to pembrolizumab or any of its excipients.

    3.Non-adequate hematological or biochemical parameters as specified below:
    a.Hemoglobin < 8.0 g/dl.
    b.Platelets count < 75 x109/L without previous platelet transfusions in the last 7 days.
    c.Neutrophils (ANC) <1 × 109/L without growth factor support (defined as no growth factor administration for at least 14 days prior to observation).
    d.Aspartate transaminase (AST): > 2.5 x the upper limit range.
    e.Alanine transaminase (ALT): > 2.5 x the upper limit range.
    f.Total bilirubin: > 2 x the upper limit range.
    g.Creatinine clearance: < 30 mL/min (measured or calculated with the Cockcroft and Gault formula).

    4.Absence of recovery from any significant non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTCAE grade < 2 symptomatic peripheral neuropathy is allowed.

    5.Pregnant or lactating women or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Female subjects of childbearing potential should have a negative urine or serum pregnancy prior to study registration and re-tested within 72 hours prior to receiving the first dose of study medication.

    6.Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception). Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

    7.Previous history of any other malignancy in the last 5 years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).

    8.More than 2 prior lines of therapy for Multiple Myeloma.

    9.Previous allogeneic stem cell transplantation.

    10.Other relevant diseases or adverse clinical conditions:
    a.Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
    b.Uncontrolled arterial hypertension or cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
    c.History of significant neurological or psychiatric disorders.
    d.Active infection.
    e.Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
    f.Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).

    11.Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen?s syndrome will not be excluded from the trial.

    12.Patient is known to be HIV positive, Hepatitis B surface antigen-positive, has active hepatitis C infection or has active tuberculosis.

    13.Limitation of the patient?s ability to comply with the treatment or follow-up protocol.
    1.Tratamiento previo con anticuerpos anti-PD1, anti-PDL1, anti-PDL2, anti-CD137 o antígeno 4 asociado a linfocitos T citotóxicos (CTLA-4), incluidos ipilimumab y otros anticuerpos o fármacos dirigidos específicamente a la coestimulación de linfocitos T.

    2.Hipersensibilidad conocida al pembrolizumab o a cualquiera de sus excipientes.

    3.Parámetros hematológicos o bioquímicos no adecuados, como se especifica a continuación:
    a.Hemoglobina: < 8 g/dl.
    b.Plaquetas: < 75 ? 109/l, sin transfusiones de plaquetas en los últimos 7 días.
    c.Neutrófilos (RAN): < 1 ? 109/l, sin soporte de factor de crecimiento (definido como ausencia de administración de factor de crecimiento durante al menos 14 días antes del análisis).
    d.Aspartato-transaminasa (AST): > 2,5 veces el límite superior de normalidad.
    e.Alanina-transaminasa (ALT): > 2,5 veces el límite superior de normalidad.
    f.Bilirrubina total: > 2 veces el límite superior de normalidad.
    g.Aclaramiento de creatinina: < 30 ml/min (medido o calculado con la fórmula de Cockcroft y Gault).

    4.Ausencia de recuperación de cualquier toxicidad significativa no hematológica derivada de tratamientos previos. Está permitida la presencia de neuropatía periférica sintomática de grado < 2 según los criterios del CTCAE-NCI NCI v. 4.03 y alopecia.

    5.Mujeres embarazadas o en lactancia, y aquellas que esperan tener o concebir hijos a lo largo de la duración prevista del estudio, desde la visita de selección hasta 120 días después de la última dosis del tratamiento del estudio. Las mujeres con potencial reproductiva deben tener una prueba de embarazo en orina o suero negativa antes de su inclusión en el estudio, y la prueba debe repetirse en las 72 horas previas a la administración de la primera dosis de la medicación de estudio.

    6.Hombres y mujeres con potencial reproductor que no estén utilizando métodos anticonceptivos eficaces (doble barrera, dispositivo intrauterino, anticonceptivos orales). Los participantes varones tienen que aceptar el uso de un método anticonceptivo adecuado desde la primera dosis del tratamiento del estudio hasta 120 días después de la última.

    7.Antecedentes de otra neoplasia maligna en los últimos 5 años (excepto carcinoma de células basales, epitelioma cutáneo o carcinoma in situ de cualquier área).

    8.Más de dos líneas de tratamiento previas para el Mieloma Múltiple.

    9.Trasplante alogénico de células madre previo.

    10.Otras enfermedades o trastornos clínicos adversos relevantes:
    a.Insuficiencia cardíaca congestiva o angina de pecho, infarto de miocardio en los 12 meses previos a la inclusión en el estudio.
    b.Arritmias cardíacas o hipertensión arterial no controladas (que hayan requerido un cambio de medicación en los 3 últimos meses o un ingreso hospitalario en los últimos 6 meses).
    c.Antecedentes de trastornos neurológicos o psiquiátricos significativos.
    d.Infección activa.
    e.Hepatopatía no neoplásica significativa (p. ej., cirrosis, hepatitis crónica activa).
    f.Enfermedades endocrinas no controladas, como diabetes mellitus, hipotiroidismo o hipertiroidismo (p. ej., que hayan requerido cambios importantes de medicación en el último mes o ingreso hospitalario en los últimos 3 meses).

    11.Enfermedad autoinmunitaria activa, antecedentes documentados de enfermedad autoinmunitaria, o un síndrome que requiera corticoides sistémicos o inmunodepresores. Los sujetos con vitíligo o asma/atopia infantil resuelta serían una excepción a esta norma. Aquellos que precisen broncodilatadores o inyecciones de corticoides locales de forma intermitente no serán excluidos del estudio. Las personas con hipotiroidismo estable en tratamiento hormonal sustitutivo o síndrome de Sjögren tampoco serán descartados del ensayo.

    12.Paciente del que se sabe que es VIH positivo, o tiene antígeno de superficie del virus de la hepatitis B, o paciente con infección activa por hepatitis C o tuberculosis activa.

    13.Capacidad limitada del paciente para cumplir el período de tratamiento o de seguimiento del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:Upgrade of the response obtained with a previous therapy (VGPR to ≥CR; CR to ≥sCR; sCR-MRD+ to immunophenotypic CR) after treatment with MK-3475 as consolidation therapy in MM patients with residual disease.
    Eficacia:Mejora de la respuesta obtenida con un tratamiento previo (de VGPR a ≥CR; de CR a ≥sCR; de sCR-MRD+ a CR inmunofenotípica) tras la administración de MK-3475 como terapia de consolidación en pacientes con mieloma múltiple con enfermedad residual.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Since the visit of selection (evaluation disease before doses administration) until end of trial (after follow-up period). According to modified IMWG criteria.
    Desde la visita de selección (evaluación e la enfermedad antes de administración de dosis) hasta fin de ensayo (tras periodo de seguimiento). De acuerdo a criterios IMWG modificados.
    E.5.2Secondary end point(s)
    Safety:
    -Clinical and laboratory toxicities and rate of discontinuation of MK-3475 monotherapy in patients with MM with persistent residual disease.
    Efficacy:
    -Incidence of achievement of immunophenotypic sCR (MRD-) with MK-3475 monotherapy administered as consolidation therapy in patients with MM with persistent residual disease.
    -Pharmacodynamic parameters: basal levels of PD1/PDL1, receptor occupancy and immune activation markers
    Seguridad:
    -Toxicidades clínicas y de laboratorio, y tasa de discontinuación de la monoterapia con MK-3475 en pacientes con mieloma múltiple con enfermedad residual persistente.
    Eficacia:
    -Incidencia de consecución de sCR inmunofenotípica (MRD-) con la monoterapia con MK-3475 administrado como terapia de consolidación en pacientes con MM con enfermedad residual persistente.
    -Parámetros farmacodinámicos: concentraciones basales de PD1/PDL1, ocupación de los receptores y marcadores de activación inmunitaria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:During all the participation of the patient in the study
    Efficacy:Since the visit of selection (evaluation disease before doses administration) until end of trial (after follow-up period).
    Seguridad:Durante toda la participación del sujeto en el ensayo
    Eficacia:Desde la visita de selección (evaluación e la enfermedad antes de administración de dosis) hasta fin de ensayo (tras periodo de seguimiento).
    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 No
    E.6.7Pharmacodynamic Yes
    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) 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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LPLS + 6 month follou-up period
    Ultima visita del ultimo paciente + 6 meses de periodo de seguimiento
    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
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Disabled patient's
    Pacientes incapacitados legalmente o pacientes incapacitados
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None (habitual clinical practice)
    Ninguno (se seguirá con la practica clínica habitual para el perfil de paciente)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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