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    Summary
    EudraCT Number:2016-004039-19
    Sponsor's Protocol Code Number:GEIS-51
    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:2016-12-27
    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 number2016-004039-19
    A.3Full title of the trial
    Phase II multicenter trial of palbociclib in second line of advanced sarcomas with CDK4 overexpression.
    Ensayo fase II multicéntrico de palbociclib en segunda línea de sarcomas avanzados con sobreexpresión CDK4.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II multicenter trial of palbociclib in second line of advanced sarcomas with CDK4 overexpression
    Ensayo fase II multicéntrico de palbociclib en segunda línea de sarcomas avanzados con sobreexpresión CDK4.
    A.3.2Name or abbreviated title of the trial where available
    PalboSarc
    PalboSarc
    A.4.1Sponsor's protocol code numberGEIS-51
    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 SponsorGrupo Español de Investigación en Sarcomas (GEIS)
    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 supportGrupo Español de Investigación en Sarcomas
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSofpromed Investigación Clínica, SLU
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressC/ del Ter, 27 - 2ª Planta Izq. - Of. 11
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34971439900
    B.5.5Fax number+34971570222
    B.5.6E-mailinfo@sofpromed.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 Yes
    D.2.1.1.1Trade name Ibrance
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameIbrance
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNPALBOCICLIB
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number70 to 125
    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
    Patients with advanced soft tissue sarcomas and osteosarcomas
    Pacientes con sarcomas de partes blandas y osteosarcomas avanzados
    E.1.1.1Medical condition in easily understood language
    Patients with advanced soft tissue sarcomas and osteosarcomas
    Pacientes con sarcomas de partes blandas y osteosarcomas avanzados
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the progression free survival (PFS) rate according to RECIST 1.1 criteria at 6 months
    Determinar la tasa de supervivencia libre de progresión (SLP) según RECIST 1.1 a los 6 meses
    E.2.2Secondary objectives of the trial
    • To evaluate objective response rate (ORR) according to RECIST 1.1
    • To evaluate response according to Choi criteria
    • To evaluate median PFS
    • To evaluate PFS rate at 3 months
    • To evaluate overall survival (OS)
    • To evaluate clinical benefit rate (CBR)
    • To evaluate safety profile according to CTCAE 4.0
    • Evaluar la tasa de respuesta objetiva (TRO) según criterios RECIST 1.1
    • Evaluar la respuesta según criterios Choi
    • Evaluar la mediana de SLP
    • Evaluar la tasa de SLP a los 3 meses
    • Evaluar la supervivencia global (SG)
    • Evaluar la tasa de beneficio clínico (TBC)
    • Evaluar el perfil de seguridad según CTCAE 4.0
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational sub-study

    Objetives:

    1.- To assess the expression of RNAm and CDK4 protein (and p16ink4a) in tumor samples of patients diagnosed with sarcoma (blood and paraffin block), to identify the most reliable and effective method to select CDK4 and/or p16ink4a as predictive biomarker of palbociclib efficacy.
    2.- To evaluate the predictive and/or prognostic value, at RNAm and protein level, of p53, p21CIP1, p27KIP1, Rb, FoxM1 and D1 cyclin as potential biomarkers of palbociclib efficacy, in blood samples and paraffin blocks (pre- and post-treatment).
    3.- To analyze other senescence markers (combination of negative Ki67 with high density (>5 per nucleus) of γH2A.X focus) through immunohistochemistry of paraffin blocks (pre- and post-treatment). Pre and post- treatment samples of each patient will be compared to determine the senescence induced by the palbociclib treatment.
    4.- To correlate the predictive biomarkers of the efficacy of palbociclib with the results obtained in clinical practice, such as PFS, OS and the clinical benefit rates (complete response, partial response and stable disease).
    5.- To evaluate the effect of palbociclib in the modulation of immune response in paraffin block samples in patients subjected to chemotherapy. The evaluation will be done in pre- and post-treatment samples of each patient.
    Subestudio traslacional

    Objetivos:

    1.- Valorar la expresión de ARNm y proteína CDK4 (y p16ink4a) en muestras de tumores de pacientes diagnosticados con sarcoma (sangre y bloque de parafina), para identificar el método más fiable y eficaz para seleccionar CDK4 y/ o p16ink4a como biomarcador predictivo de la eficacia de palbociclib.
    2.- Evaluar el valor predictivo y/ o pronóstico, al nivel de ARNm y proteína, de p53, p21CIP1, p27KIP1, Rb, FoxM1 y ciclina D1 como potenciales biomarcadores de la eficacia de palbociclib, en muestras de sangre y en bloques de parafina (pre- y post-tratamiento).
    3.- Analizar otros marcadores de senescencia (combinación de Ki67 negativo con alta densidad (>5 por núcleo) de focos de γH2A.X) por inmunohistoquímica de bloques de parafina (pre- y post-tratamiento). Muestras pre- y post-tratamiento de cada paciente serán comparadas para determinar la senescencia inducida por el tratamiento con palbociclib.
    4.- Correlacionar los biomarcadores predictivos de la eficacia de palbociclib con los resultados obtenidos en la clínica, como la SLP, SG y las tasas de beneficio clínico (respuesta completa, respuesta parcial y enfermedad estable).
    5.- Evaluar el efecto de palbociclib en la modulación de la respuesta inmune en muestras de bloques de parafina de pacientes sometidos a la quimioterapia. La evaluación será ejecutada en muestras pre- y post-tratamiento de cada paciente.
    E.3Principal inclusion criteria
    1) Over-expression of CDK4 (mRNA expression) and a low-to-normal p16 expression (mRNA expression) measured in paraffin embedded tumor samples at study entry.
    2) ECOG 0-1 at enrollment.
    3) Diagnosis of soft tissue sarcoma or osteosarcoma (in both cases with metastasis or locally advanced, unresectable).
    4) Disease progression documented within 6 months prior to study entry.
    5) Patients must have the following laboratory results:
    • ANC ≥ 1,500/mm3 (1.5 x 109/L);
    • Platelets ≥ 100,000/mm3 (100 x 109/L);
    • Hemoglobin ≥ 9 g/dL (90 g/L);
    • Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min;
    • Total serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert’s disease);
    • AST and/or ALT ≤ 3 x ULN (≤ 5.0 x ULN if liver metastases present);
    • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if bone or hepatic metastasis present);
    6) Patients must have signed written informed consent to participate in the clinical study, and to provide at least two paraffin embedded tumor blocks for the molecular analyses at screening stage.
    7) Biopsy at baseline if there are no archived tumor samples obtained within 3 months prior to treatment initiation.
    8) Patients must have received standard treatments for at least one or two lines for advanced disease.
    9) Age between 18 and 80 years (both ages included).
    10) Measurable disease according to RECIST 1.1 criteria.
    11) All patients (men and women) in fertile age must use an effective contraception method during the entire treatment with palbociclib and for at least 90 days after the last dose. Pregnancy must be ruled out through urine or blood test (negative pregnancy test) for the inclusion in the study. Men must be informed to consider spermatic preservation before treatment initiation due to infertility risks.
    1) Sobreexpresión de CDK4 (expresión de mRNA) y una expresión baja o normal de p16 (expresión de mRNA) medidas en muestras de tumor en parafina a la entrada en el estudio.
    2) ECOG 0-1 en el momento de la inclusión.
    3) Diagnóstico de sarcoma de partes blandas u osteosarcoma (en ambos casos con metástasis o localmente avanzado no operable).
    4) Progresión de la enfermedad documentada durante los 6 meses previos a la entrada en el estudio.
    5) Los pacientes deben tener los siguientes resultados de laboratorio:
    • Recuento absoluto de neutrófilos ≥ 1.500/mm3 (1,5 x 109/L);
    • Plaquetas ≥ 100.000/mm3 (100 x 109/L);
    • Hemoglobina ≥ 9 g/dL (90 g/L);
    • Creatinina en sangre ≤ 1,5 x LSN o aclaramiento de creatinina estimada ≥ 60 mL/min;
    • Bilirrubina total en sangre ≤ 1,5 x LSN (≤ 3,0 x LSN si enfermedad de Gilbert);
    • AST y/o ALT ≤ 3 x LSN (≤ 5,0 x LSN si existe metástasis hepática);
    • Fosfatasa alcalina ≤ 2,5 x LSN (≤ 5,0 x LSN si existe metástasis ósea o hepática);
    6) Los pacientes deben haber firmado el consentimiento escrito para participar en el estudio clínico, y para aportar al menos dos bloques de tumor en parafina para los análisis moleculares de la fase de selección.
    7) Biopsia en el periodo basal si no hay muestras de tumor de archivo obtenidas en los 3 meses previos al inicio del tratamiento.
    8) Los pacientes deben haber recibido los tratamientos estándar para al menos una o dos líneas para enfermedad avanzada.
    9) Edad entre 18 y 80 años (ambas edades incluidas).
    10) Enfermedad medible según criterios RECIST 1.1
    11) Todos los pacientes (hombres y mujeres) en edad fértil deben usar un método eficaz anticonceptivo durante todo el tratamiento con palbociclib y por al menos 90 días después de la última dosis. Debe descartarse el embarazo mediante prueba de orina o sangre (test de embarazo negativo) para la inclusión en el estudio. A los hombres se les debe comunicar que consideren la preservación espermática antes de comenzar el tratamiento debido a los riesgos de infertilidad.
    E.4Principal exclusion criteria
    1) Previous treatment with any anti CDK4 or immune checkpoint inhibitor.
    2) Diagnosis of Ewing sarcoma or rhabdomyosarcoma.
    3) Diagnosis of well differentiated/dedifferentiated liposarcoma.
    4) Patients irradiated on the only target lesion available.
    5) Patients having received more than two lines for advanced disease.
    6) History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
    7) Serious cardiovascular disease (NYHA >= 2)
    8) Grade 3 or superior toxicity according to CTCAE 4.0 if the investigator considers this can significantly interfere in the toxicity of the drug under study.
    9) Patients not recovered from a previous toxicity to at least CTCAE Grade 1 due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies).
    10) Patients not recovered from minor or major surgery or having undergone a major surgery within the last 4 weeks prior to initiation of study treatment.
    11) Central nervous system metastasis.
    12) Pregnant or breastfeeding patients, or those expecting to conceive or father children within the projected duration of treatment.
    13) Foods or drugs known as CYP3A4 inhibitors/inducers; CYP3A4 substrates with narrow therapeutic windows, or known to prolong QTc interval.
    14) Major surgery, chemotherapy, radiotherapy, any agent under investigation, or other antineoplastic therapy within 4 weeks prior to inclusion. Patients having received a previous radiotherapy ≥25% of bone marrow are not eligible, regardless of when it was received.
    15) QTc > 480 ms; personal or family history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsades de Pointes (TdP).
    16) Any of the following situations within 6 months prior to study drug administration: myocardial infarction, serious/unstable angina, current cardiac dysrhythmias Grade ≥ 2 NCI-CTCAE version 4.0, atrial fibrillation of any grade, bypass graft in coronary/peripheral artery, symptomatic congestive cardiac failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
    17) Known hypersensitivity to any PD 0332991 or excipients.
    18) Active or recent suicide attempt or behavior.
    1) Tratamiento previo con cualquier anti CDK4 o inhibidores de punto de control inmunitarios.
    2) Diagnóstico de sarcoma de Ewing o rabdomiosarcoma.
    3) Diagnóstico de liposarcoma bien diferenciado/desdiferenciado.
    4) Pacientes irradiados en la única lesión diana disponible.
    5) Pacientes que hayan recibido más de dos líneas para la enfermedad avanzada.
    6) Historial de otra enfermedad neoplásica con la excepción de carcinoma de células basales o cáncer cervical in situ tratados adecuadamente.
    7) Enfermedad cardiovascular grave (NYHA >= 2)
    8) Toxicidad grado 3 o superior según CTCAE 4.0 si a criterio del investigador puede interferir de forma significativa en la toxicidad del fármaco objeto de estudio.
    9) Pacientes que no se hayan recuperado de una toxicidad previa hasta un CTCAE grado 1 debido a un tratamiento antineoplásico previo con quimioterapia, radioterapia, o terapia biológica (incluyendo anticuerpos monoclonales).
    10) Pacientes que no se hayan recuperado de una cirugía menor o mayor o que hayan tenido una cirugía importante en las 4 semanas previas al inicio del tratamiento del estudio.
    11) Metástasis en el sistema nervioso central.
    12) Pacientes embarazadas o en periodo de lactancia, o que esperan concebir niños durante el periodo de tratamiento.
    13) Comidas o fármacos conocidos como inhibidores/inductores de CYP3A4; substratos CYP3A4 con ventanas terapéuticas estrechas, o que se sepa que prolongan el intervalo QTc
    14) Cirugía importante, quimioterapia, radioterapia, cualquier agente en investigación, u otra terapia antineoplásica dentro de las 4 semanas previas a la inclusión. Los pacientes que hayan recibido una radioterapia previa ≥25% de la médula ósea no son elegibles, independientemente de cuándo se recibió.
    15) QTc > 480 ms; historial personal o familiar de síndrome QT largo o corto, síndrome de Brugada o historial conocido de prolongación QTc, o Torsades de Pointes (TdP).
    16) Cualquiera de las siguientes situaciones dentro de los 6 meses previos a la administración del fármaco del estudio: Infarto de miocardio, angina severa/inestable, disritmias cardiacas actuales de Grado ≥ 2 NCI-CTCAE versión 4.0, fibrilación atrial de cualquier grado, implante de marcapasos en arteria coronaria/periférica, fallo cardiaco congestivo sintomático, accidente cerebrovascular incluyendo ataque isquémico transitorio, o embolismo pulmonar sintomático.
    17) Hipersensibilidad conocida a cualquier PD 0332991 o excipientes.
    18) Intención o comportamiento suicida activo o reciente.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.
    Eficacia medida mediante la tasa de supervivencia libre de progresión (SLP) a los 6 meses, evaluada con criterios RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    A los 6 meses
    E.5.2Secondary end point(s)
    • Efficacy measured through the objective response rate (ORR) (complete response [CR] and partial response [PR]), evaluated with RECIST 1.1 criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
    • Efficacy measured through response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
    • Efficacy measured through median PFS.
    • Efficacy measured through PFS rate at 3 months.
    • Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.
    • Clinical Benefit Rate (CBR). Patients having shown complete response, partial response, or disease stabilization during 6 months or more, showing clinical improvement symptoms, will be considered as having experienced clinical benefit.
    • Palbociclib safety profile, through the evaluation of adverse events (type, incidence, severity, timing of appearance, related causes) observed in physical explorations and laboratory tests. Toxicity will be assessed and tabulated using
    NCI-CTCAE 4.0
    • Eficacia medida mediante la tasa de respuesta objetiva (TRO) (respuesta completa [RC] y respuesta parcial [RP]), evaluada con criterios RECIST 1.1. Los criterios de evaluación se basarán en la identificación de las lesiones diana en tiempo basal y el seguimiento de estas hasta la progresión del tumor.
    • Eficacia medida mediante respuesta según criterios Choi. Los criterios de evaluación se basarán en la identificación de las lesiones diana en tiempo basal y el seguimiento de estas hasta la progresión del tumor.
    • Eficacia medida mediante la mediana de SLP
    • Eficacia medida mediante la tasa de SLP a los 3 meses
    • Supervivencia global (SG) medida desde la fecha de inicio del tratamiento con palbociclib hasta la fecha de muerte, sea cual sea la causa
    • Tasa de beneficio clínico (TBC). Los pacientes que hayan mostrado respuesta completa, respuesta parcial o estabilización de la enfermedad durante 6 meses o más, presentando síntomas de mejora clínica, serán considerados como que han experimentado beneficio clínico.
    • Perfil de seguridad de palbociclib, mediante la evaluación de acontecimientos adversos (tipo, incidencia, severidad, momento de la aparición, causas relacionadas) observados en exploraciones físicas y pruebas de laboratorio. La toxicidad será analizada y tabulada usando NCI-CTCAE 4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Efficacy measured through the objective response rate (ORR): 6 months
    • Efficacy measured through response according to Choi criteria: 6 months
    • Efficacy measured through median PFS: 6 months
    • Efficacy measured through PFS rate at 3 months.
    • Overall survival (OS): 2 years
    • Clinical Benefit Rate (CBR): 6 months
    • Palbociclib safety profile, through the evaluation of adverse events: 1 year
    • Eficacia medida mediante la tasa de respuesta objetiva (TRO): 6 meses
    • Eficacia medida mediante respuesta según criterios Choi: 6 meses
    • Eficacia medida mediante la mediana de SLP: 6 meses
    • Eficacia medida mediante la tasa de SLP a los 3 meses
    • Supervivencia global (SG): 2 años
    • Tasa de beneficio clínico (TBC): 6 meses
    • Perfil de seguridad de palbociclib: 1 año
    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 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 Yes
    E.8.1.7.1Other trial design description
    Traslacional (estudio de biomarcadores)
    Translational (biomarker 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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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
    The study will be considered closed from a normative point of view after data on primary and secondary variables are sufficiently prepared for its initial publication.
    El estudio se considerará cerrado desde un punto de vista normativo después de que los datos relacionados con las variables principales y secundarias estén lo suficientemente preparados para publicación inicial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state38
    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 Decision2017-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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