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    Summary
    EudraCT Number:2016-000764-42
    Sponsor's Protocol Code Number:UC-0140/1606-BIG16-01
    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:2017-10-31
    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 number2016-000764-42
    A.3Full title of the trial
    A Phase II Trial Testing Durvalumab Combined With Endocrine Therapy in Patients With ER+/Her2- Breast Cancer Eligible for Neoadjuvant Endocrine Therapy And Who Present CD8+ T Cell Infiltration After 4-6 Weeks Exposure to Immune-Attractant.
    Ensayo de fase II que analiza durvalumab en combinación con el tratamiento endocrino en pacientes con cáncer de mama ER+/her2- aptas para tratamiento endocrino neoadyuvante y que presentan infiltración de linfocitos T CD8+ tras 4-6 semanas de exposición a inmunoatrayente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    ULTIMATE
    ULTIMATE
    A.4.1Sponsor's protocol code numberUC-0140/1606-BIG16-01
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportAstra Zeneca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointJérôme Lemonnier
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33144 23 04 65
    B.5.5Fax number33144 23 04 69
    B.5.6E-mailj-lemonnier@unicancer.fr
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDURVALUMAB
    D.3.9.1CAS number 1428935-60-7
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameTremelimumab
    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 INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.3Other descriptive nameTREMELIMUMAB
    D.3.9.4EV Substance CodeSUB37101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.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 ER+ and HER2- primary non-metastatic breast cancer who are eligible to neoadjuvant endocrine therapy.
    Pacientes con cáncer de mama primario no metastásico ER+ y HER2- aptas para tratamiento endocrino neoadyuvante.
    E.1.1.1Medical condition in easily understood language
    Non-metastatic breast cancer
    Cancer de mama no metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast 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
    To assess the efficacy of durvalumab combined with exemestane in patients with CD8+ T cells on pathological response at surgery after a lymphocyte attraction phase.
    Evaluar la eficacia de durvalumab combinado con exemestano en pacientes con linfocitos T CD8+ sobre la respuesta patológica en la cirugía tras una fase de atracción de linfocitos.
    E.2.2Secondary objectives of the trial
    Efficacy:To evaluate the capacity of several “immune-attractants” approaches to increase CD8+ T cells in the tumor site and to determine the best “immune-attractant”. By comparing the rate of CD8+ T cells after part 1treatment with rate of CD8+ Tcells at baseline. Assess the efficacy of six months durvalumab + exemestane combination therapy in ER+/Her2- BC presenting CD8+ T cells after 6weeks exposure to immune-attractants on secondary endpoints. Evaluate whether durvalumab expands intratumor lymphocytes. Safety:Assess the safety of each treatment. Molecular:Assess the predictive value of mutational load, PDL1 expression on the efficacy of durvalumab. Identify predictive biomarkers,expression and copy number data for the efficacy of durvalumab. Explore the pCR after 6months durvalumab + exemestane according lymphocyte attraction treat. Assess CD8+ cells in surgical specimens of non-pCR patients. Correlate Immune infiltrate intensity with the proportion of tumor cells expressing PD-L1.
    -
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Research of biomarkers.
    Investigación de Biomarcadores
    E.3Principal inclusion criteria
    1. Age ≥18 years post-menopausal according to one of the following criteria:
    Age > 60 years
    Or Bilateral ovariectomy
    Or Age ≤ 60, with an uterus and presenting an amenorrhea of more than 12 months and FSH and estradiol in the postmenopausal range
    Or Age ≤ 60, without an uterus and FSH and estradiol in the postmenopausal range
    2. Histologically proven invasive breast cancer eligible to neoadjuvant endocrine therapy according to multidisciplinary tumor board;
    Note: Multicentric/multifocal tumors are allowed if all share the same characteristics.
    3. cT2-T4, any N; cT2 are eligible only if the clinical tumor size is > 3cm
    4. Non metastatic, M0 (according to clinical staging);
    5. Luminal A patients ER-positive by IHC according to the following criteria (local assessment): Grade I or II AND ER-positive (≥ 60%) AND Ki67 <20%;
    6. Her2-negative by IHC (score 0 or 1+) and/or FISH/CISH negative according to local assessment;
    7. CD8+ T Cell infiltration defined as >10% cells stained with anti-CD8 mAB by IHC at the 3-week biopsy (applicable for inclusion in part 2 only);
    8. Available tumor samples from baseline biopsy;
    9. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrolment;
    10. Adequate organ and marrow function as defined below:
    Hemoglobin ≥9.0 g/dL
    Absolute neutrophil count ≥1.5 × 109 /L
    Platelet count ≥100 × 109/L
    Serum bilirubin ≤1.5 × the ULN. This will not apply to patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
    ALT and AST ≤2.5 × ULN;
    Adequate renal function as determined by CKD-EPI formula (using actual body weight)
    11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
    12. Written informed consent obtained prior to performing any protocol-related procedures, including screening evaluations.

    1. Edad ≥ 18 años, postmenopáusica conforme a uno de los criterios siguientes:
    Edad > 60 años.
    U ovariectomía bilateral.
    O edad ≤ 60 años, con útero y con amenorrea de más de 12 meses y niveles de FSH y estradiol dentro del intervalo posmenopáusico.
    O edad ≤ 60 años, sin útero y con niveles de FSH y estradiol dentro del intervalo posmenopáusico.
    2. Cáncer de mama invasivo (demostrado mediante análisis histológico) apto para tratamiento endocrino neoadyuvante según un comité multidisciplinario de evaluación de tumores.
    Nota: Se permite la presencia de tumores multicéntricos/multifocales si todos comparten las mismas características.
    3. cT2-T4, cualquier N; en cT2 aptas solo si el tamaño del tumor clínico es > 3 cm.
    4. M0, no metastásico (según estadificación clínica).
    5. Pacientes con luminal A ER positivos por IHQ según los criterios siguientes (evaluación local): grado I o II Y ER positivos (≥ 60 %) Y Ki67 < 20 %;
    6. Her2 negativo por IHQ (puntuación 0 o 1+) y/o FISH/CISH negativo según la evaluación local.
    7. Infiltración de linfocitos T CD8+ definida como > 10 % de células teñidas con AcM anti-CD8 por IHQ en la biopsia de la 3.ª semana (aplicable para la inclusión en la parte 2 solamente).
    8. Disponibilidad de muestras tumorales de la biopsia basal.
    9. Estado funcional de la Organización Mundial de la Salud (OMS)/Eastern Cooperative Oncology Group (ECOG) de 0 o 1 en el momento de la inclusión.
    10. Función adecuada de los órganos y la médula ósea según se define a continuación:
    Hemoglobina ≥ 9,0 g/dl
    Recuento absoluto de neutrófilos ≥ 1,5 × 109/l
    Recuento de plaquetas ≥ 100 × 109/l
    Bilirrubina sérica ≤ 1,5 × LSN. Este parámetro no se aplicará a las pacientes con síndrome de Gilbert confirmado, a quienes se les permitirá participar tras consultar con su médico.
    ALT y AST ≤ 2,5 × LSN.
    Función renal adecuada según se determine mediante la fórmula CKD-EPI (utilizando el peso corporal real).

    11. Disposición y capacidad de cumplir con las visitas programadas, el plan de tratamiento, las analíticas y otros procedimientos del ensayo.
    12. Consentimiento informado por escrito obtenido antes de realizar ningún procedimiento relacionado con el protocolo, incluidas las evaluaciones de selección.
    E.4Principal exclusion criteria
    1. Inflammatory breast cancer

    2. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines;

    3. Any concurrent chemotherapy, investigational product (IP), biologic therapy for cancer treatment;

    4. Previous Radiotherapy treatment to more than 30% of the bone marrow;

    5. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose;

    6. History of allogenic organ transplantation;

    7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
    - Patients with vitiligo or alopecia
    - Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment;

    8. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of investigational product or interpretation of patient safety or study results, including ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events from investigational products, or compromise the ability of the patient to give written informed consent;

    9. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥470 ms;

    10. History of active primary immunodeficiency;

    11. Known history of active tuberculosis;

    12. Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

    13. Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion:
    - Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
    - Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent
    - Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

    14. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
    Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.

    15. Known allergy or hypersensitivity to any medicinal product used in the trial or any excipient
    1. Cáncer de mama inflamatorio.

    2. Ninguna exposición previa a tratamiento inmunomediado, incluidos, entre otros, otros anticuerpos anti-CTLA-4, anti-PD-1, anti-PD-L1 y anti-PD-L2 (anti ligando de muerte celular programada 2), excepto las vacunas antineoplásicas terapéuticas.

    3. Cualquier tipo de quimioterapia, producto en investigación (PEI) o tratamiento biológico concurrentes para el tratamiento del cáncer.

    4. Radioterapia previa a más del 30 % de la médula ósea.

    5. Intervención quirúrgica importante (según lo defina el investigador) en los 28 días previos a la primera dosis.

    6. Antecedentes de trasplantes de órganos alógenos.

    7. Trastornos autoinmunitarios activos o anteriores documentados (incluida enfermedad intestinal inflamatoria [p. ej., colitis o enfermedad de Crohn], diverticulitis con excepción de diverticulosis, celiaquía u otras afecciones gastrointestinales crónicas graves asociadas con diarrea), lupus eritematoso sistémico, síndrome de sarcoidosis o síndrome de Wegener (granulomatosis con poliangitis), enfermedad de Graves, artritis reumatoide, hipofisitis, uveítis, etc. en los últimos 3 años antes del inicio del tratamiento. Estas son excepciones a este criterio:
    - Pacientes con vitíligo o alopecia.
    - Pacientes con hipotiroidismo (p. ej., después de síndrome de Hashimoto) estable en tratamiento con terapia hormonal sustitutiva o psoriasis que no requiere tratamiento sistémico.

    8. Cualquier afección que, según la opinión del investigador, interferiría con la evaluación del producto en investigación o interpretación de los resultados de la seguridad del paciente o del estudio, incluida infección en curso o activa, insuficiencia cardíaca congestiva sintomática, hipertensión no controlada, angina de pecho inestable, arritmia cardiaca, enfermedad pulmonar intersticial o enfermedad psiquiátrica/situaciones sociales que limitarían el cumplimiento con los requisitos del estudio, aumentarían notablemente el riesgo de aparición de acontecimientos adversos de los productos en investigación o pondrían en peligro la capacidad del paciente de otorgar su consentimiento informado por escrito.

    9.Intervalo QT corregido medio para la frecuencia cardíaca utilizando la fórmula de Fridericia (QTcF) ≥ 470 ms.

    10.Antecedentes de inmunodeficiencia primaria activa.

    11.Antecedentes conocidos de tuberculosis activa.

    12.Infección activa incluida hepatitis B, hepatitis C o virus de la inmunodeficiencia humana (VIH).

    13.Uso actual o anterior de medicamentos inmunodepresores en los 14 días anteriores a la primera dosis. Estas son excepciones a este criterio:
    - Corticoides intranasales, inhalados, tópicos o inyecciones locales de corticoides (p. ej., inyección intrarticular).
    - Corticoides sistémicos a dosis fisiológicas que no superen los 10 mg/día de prednisona o su equivalente.
    - Corticoides como premedicación para reacciones de hipersensibilidad (p. ej., premedicación para TAC).

    14. Recepción de vacunas con virus vivos atenuados en los 30 días previos a la primera dosis del PEI.
    Nota: Los pacientes, si se incluyen, no deberán recibir vacunas con virus vivos durante el estudio y hasta 30 días después de la última dosis de PEI.

    15. Alergia o hipersensibilidad conocidas a cualquier medicamento que se utilice en el ensayo o a cualquiera de sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of pathological complete response on the surgical specimen.
    Tasa de respuesta completa patológica en la muestra quirúrgica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable.
    E.5.2Secondary end point(s)
    EFFICACY CRITERIA
    -Number of CD8+ T cells
    - Clinical response after 6 months therapy. Clinical response is determined by tumor assessments performed by palpation
    -Assessment of Ki67 on the surgical specimen according to the recommendations from the International Ki67 in Breast cancer Working Group.
    -Measurement of TILs according to the recommendations published by the international TILs working group 2014

    SAFETY
    - According to the CTC-AE v4.03.

    TRANSLATIONAL RESEARCH (EXPLORATORY ENDPOINTS):
    - Predictive value of Mutational load for the efficacy of durvalumab will be assessed by whole exome sequencing on baseline samples
    - Predictive value of PDL1 expression for the efficacy of durvalumab will be assessed both on baseline samples and at 3 weeks biopsy (Ventana SP263 assay)
    - Other biomarker research will be defined by the study steering committee at the end of the trial to ensure the optimal use of update technologies and hypotheses
    CRITERIOS DE EFICACIA
    - Número de linfocitos T CD8+.
    - Respuesta clínica tras 6 meses de tratamiento. La respuesta clínica se determina con evaluaciones tumorales mediante palpación.
    - Evaluación de Ki67 en la muestra quirúrgica según las recomendaciones del Grupo de Trabajo Internacional de Ki67 en el cáncer de mama.
    - Medición de linfocitos infiltrantes tumorales (TIL) según las recomendaciones publicadas por el Grupo de Trabajo Internacional de TIL en 2014.

    SEGURIDAD
    Según los CTC-AE, v4.03.

    INVESTIGACIÓN TRANSLACIONAL (CRITERIOS DE VALORACIÓN EXPLORATORIOS):
    El valor predictivo de la carga mutacional para la eficacia de durvalumab se valorará mediante la secuenciación de todo el exoma de las muestras de referencia.
    El valor predictivo de la expresión de PDL1 se evaluará en las muestras de referencia y en la biopsia de la 3.ª semana (ensayo Ventana SP263).
    El comité directivo del estudio definirá la investigación de otros biomarcadores al final del ensayo para garantizar que se hace un uso óptimo de las tecnologías e hipótesis más actuales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    identification of predictive biomarkers
    Identificación de los biomarcadores predictivos
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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
    LVLS
    Ultima Visita Ultimo Paciente
    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 months
    E.8.9.1In the Member State concerned days
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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
    Ninguno
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-28
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