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    Summary
    EudraCT Number:2017-001750-34
    Sponsor's Protocol Code Number:INCB39110-207
    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:2017-09-29
    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 number2017-001750-34
    A.3Full title of the trial
    An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic
    Non–Small Cell Lung Cancer
    Estudio abierto en fase I/II de INCB039110 en combinación con osimertinib en sujetos con cáncer de pulmón no microcítico localmente avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of a new drug, INCB039110, in combination with osimertinib in patients with a type lung cancer
    Estudio de un fármaco nuevo, INCB039110, en combinación con osimertinib en sujetos con un tipo de cáncer de pulmón
    A.4.1Sponsor's protocol code numberINCB39110-207
    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 SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.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.3.1Product nameItacitinib
    D.3.2Product code INCB039110
    D.3.4Pharmaceutical form Modified-release tablet
    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 INNITACITINIB ADIPATE
    D.3.9.1CAS number 1334302-63-4
    D.3.9.2Current sponsor codeINCB039110 ADIPATE
    D.3.9.3Other descriptive nameITACITINIB ADIPATE
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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.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 Yes
    D.2.1.1.1Trade name Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameosimertinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNOSIMERTINIB MESYLATE
    D.3.9.1CAS number 1421373-66-1
    D.3.9.3Other descriptive nameOSIMERTINIB MESYLATE
    D.3.9.4EV Substance CodeSUB176836
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 3
    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 Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameosimertinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNOSIMERTINIB MESYLATE
    D.3.9.1CAS number 1421373-66-1
    D.3.9.3Other descriptive nameOSIMERTINIB MESYLATE
    D.3.9.4EV Substance CodeSUB176836
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Locally Advanced or Metastatic Non–Small Cell Lung Cancer
    Cáncer de pulmón no microcítico localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    A type of advance lung cancer
    Un tipo de cancer de pulmón avanzado
    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 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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
    PHASE I: To evaluate the safety and tolerability of INCB039110 in combination with osimertinib in subjects with locally advanced or metastatic
    NSCLC that has progressed on or after treatment with an EGFR inhibitor, and to identify a potential recommended Phase 2 dose (RP2D) for
    further study.

    PHASE II: To evaluate the antitumor activity of INCB039110 in combination with osimertinib when administered to subjects with locally advanced or metastatic NSCLC that has progressed on or after treatment with an EGFR inhibitor and evidence of an EGFR T790M mutation.
    FASE I: Evaluar la seguridad y tolerabilidad de INCB039110 en combinación con osimertinib en sujetos con cáncer de pulmón no microcítico (CPNM) localmente avanzado o metastásico que ha progresado durante o después del tratamiento con un inhibidor del receptor del factor de crecimiento epidérmico (epidermal growth factor receptor, EGFR) e identificar una posible dosis recomendada para la fase II (DRF2) para proseguir el estudio.

    FASE II: Evaluar la actividad antitumoral de INCB039110 en combinación con osimertinib cuando se administra a sujetos con CPNM localmente avanzado o metastásico que ha progresado durante o después del tratamiento con un inhibidor del EGFR e indicios de una mutación T790M del EGFR.
    E.2.2Secondary objectives of the trial
    PHASE I: To evaluate the pharmacokinetics (PK) of INCB039110 and osimertinib when administered in combination.

    PHSAE II:
    - To further evaluate the efficacy of study treatment in subjects with T790M+ NSCLC.
    - To evaluate the safety and tolerability of the combination of INCB039110 and osimertinib.
    - To evaluate the PK of INCB039110 and osimertinib when administered in combination.
    FASE I: Evaluar la farmacocinética (FC) de INCB039110 y osimertinib cuando se administran combinados.

    FASE II:
    -Evaluar adicionalmente la eficacia del tratamiento del estudio en sujetos con T790M+CPNM.
    -Evaluar la seguridad y tolerabilidad de la combinación de INCB039110 y osimertinib.
    -Evaluar la FC de INCB039110 y osimertinib cuando se administran combinados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women, 18 years of age or older at screening.
    • Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
    • Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample.
    - Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR TKI. Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.
    - Phase 2: Subjects must not have received more than 1 prior line of therapy for locally advanced or metastatic NSCLC. First-line treatment must include an EGFR TKI, and subjects must have documented disease progression during or following treatment. Subjects with disease that progressed
    more than 6 months after completion of neoadjuvant/ adjuvant chemotherapy or chemoradiation therapy are eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.
    • Radiographically measurable or evaluable disease per RECIST v1.1.
    •Hombres y mujeres de 18 años de edad como mínimo en el momento de la selección.
    •CPNM no resecable, confirmado histológica o citológicamente, localmente avanzado (estadio IIIB) o metastásico (estadio IV).
    •Indicios documentados de mutación activadora somática del EGFR (p. ej., G719X, deleción del exón 19, L858R, L861Q) en una muestra de tejido tumoral.

    -Fase I: Los sujetos deberán haber recibido previamente tratamiento con un ITC del EGFR y su enfermedad deberá haber progresado durante o después de ese tratamiento. Se permiten líneas adicionales de tratamiento sistémico, incluidos fármacos en investigación, para el CPNM localmente avanzado o metastásico.

    -Fase II: Los sujetos no deben haber recibido más de 1 línea previa de tratamiento para el CPNM localmente avanzado o metastásico. El tratamiento de primera línea deberá haber incluido un ITC del EGFR, y los sujetos deberán haber presentado una progresión de la enfermedad documentada durante o después del tratamiento. Los sujetos con enfermedad que haya progresado más de 6 meses después de finalizar una quimioterapia o quimiorradioterapia neoadyuvante/adyuvante serán considerados aptos si han recibido un ITC del EGFR como tratamiento de primera línea para el CPNM avanzado.

    •Enfermedad medible o evaluable radiográficamente conforme a RECIST v1.1.
    E.4Principal exclusion criteria
    • Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study entry
    • Insufficient renal, hepatic, and bone marrow function
    • Inability to swallow food, or significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of the study drug.
    • Clinically significant abnormalities found on an ECG.
    • Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class II, III, or IV congestive heart failure, and ongoing arrhythmia requiring therapy.
    • Past history of ILD, drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
    • Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies).
    • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
    • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
    • Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
    •Metástasis conocidas en el SNC, salvo que estén estables y sean asintomáticas. Los sujetos con metástasis en el SNC pueden ser aptos para el studio
    •Insuficiencia de la función renal, hepática y de la médula ósea
    •Imposibilidad de tragar alimentos o trastorno gastrointestinal significativo que, en opinión del investigador, podría interferir con la absorción del fármaco del estudio.
    •Anomalías clínicamente significativas encontradas en un ECG.
    •Cardiopatía clínicamente significativa o no controlada, incluida angina inestable, infarto agudo de miocardio en los 6 meses anteriores al día 1 de la administración del fármaco del estudio, insuficiencia cardíaca congestiva de clase II, III o IV de la New York Heart Association y arritmia continua que requiera tratamiento.
    •Antecedentes de EPI, EPI inducida por fármacos, neumonitis por radiación que haya requerido tratamiento con esteroides, o cualquier indicio de EPI clínicamente activa.
    •Antecedentes conocidos de infección por el virus de inmunodeficiencia humana (VIH) (anticuerpos contra VIH 1/2).
    •Enfermedad infecciosa activa, crónica o actual, que requiera tratamiento sistémico antibiótico, antifúngico o antivírico.
    •Indicios de infección por el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC)
    •Otra neoplasia maligna, actual o previa, en los 2 años anteriores a la incorporación al estudio, excepto el cáncer de piel basocelular o de células escamosas curado, cáncer de vejiga superficial, neoplasia prostática intraepitelial, carcinoma cervical in situ u otra neoplasia maligna no invasiva.
    E.5 End points
    E.5.1Primary end point(s)
    PHASE I:
    - Frequency, severity, and duration of AEs and dose-limiting toxicities (DLTs)
    -changes in clinical safety assessments
    - and changes in clinical laboratory parameters.

    PHASE II:
    - ORR, defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR) as per RECIST v1.1.
    FASE I:
    -Frecuencia, intensidad y duración de los acontecimientos adversos (AA) y toxicidades limitadoras de la dosis (TLD),
    -cambios en las evaluaciones de la seguridad clínica
    -y cambios en los parámetros analíticos clínicos.

    FASE II:
    -Tasa de respuesta objetiva (TRO), definida como el porcentaje de sujetos que presentan una mejor respuesta global confirmada de respuesta completa (RC) o respuesta parcial (RP), según la versión 1.1 de los criterios RECIST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: regularly at all study visits
    Phase II: every 8 weeks
    FASE I:regularmente en todas las visitas del estudio

    FASE II: cada 8 semanas
    E.5.2Secondary end point(s)
    PHASE I: PK endpoints include C max , C min , t max , AUC, and CL/F.

    PHASE II:
    - Depth of response (DpR), defined as the percentage of maximal tumor shrinkage observed at the lowest point (nadir) compared with baseline.
    - CR rate, defined as the percentage of subjects with a best overall response of CR.
    - Duration of response (DOR), defined as the interval from the first occurrence of CR or PR (whichever occurs first) until disease progression or death.
    - Disease control rate (DCR), defined the percentage of subjects achieving a best overall response of CR, PR, or stable disease (SD) for at least 8 weeks.
    - PFS, defined as the interval from the first day of study treatment until disease progression or death due to any cause.
    - Overall survival (OS), defined as the interval from the first day of study treatment until death due to any cause.
    - Frequency, severity, and duration of AEs; changes in clinical safety assessments; and changes in clinical laboratory parameters.
    - PK endpoints include C max , C min , t max , AUC, and CL/F.
    FASE I: Los criterios de valoración FC son la Cmáx, la Cmín, el tmáx, la AUC y el CL/F.

    FASE II:
    -Profundidad de la respuesta, definida como el porcentaje de la máxima reducción del tamaño del tumor observada en el punto más bajo (nadir) en comparación con el inicio.
    -Tasa de RC, definida como el porcentaje de sujetos con una mejor respuesta global de RC.
    -Duración de la respuesta, definida como el intervalo entre el primer caso de RC o de RP (cualquiera que ocurra primero) y la progresión de la enfermedad o la muerte.
    -Tasa de control de la enfermedad, definida como el porcentaje de sujetos que alcanzan una mejor respuesta global de RC o RP o una enfermedad estable durante al menos 8 semanas.
    -Supervivencia sin progresión (SSP), definida como el intervalo de tiempo entre el primer día del tratamiento del estudio y la progresión de la enfermedad o la muerte por cualquier causa.
    -Supervivencia general (SG), definida como el intervalo de tiempo entre el primer día del tratamiento del estudio y la muerte por cualquier causa.
    -Frecuencia, intensidad y duración de los AA, cambios en las evaluaciones de la seguridad clínica y cambios en los parámetros analíticos clínicos.
    -Los criterios de valoración FC son la Cmáx, la Cmín, el tmáx, la AUC y el CL/F.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I: Days 1, 8, 15 and 28 of each cycle

    Phase II: regularly at all study visits
    FASE I: Dias 1, 8, 15 y 28 de cada ciclo

    FASE II: regularmente en todas las visitas del estudio
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and tolerability
    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.8.2.4Number 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 concerned3
    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 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
    Korea, Republic of
    Spain
    Taiwan
    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 will end once all subjects have been withdrawn from study treatment and 75% of the
    subjects in the survival follow-up have died, withdrawn consent, or are lost to follow-up.
    El estudio finalizará una vez todos los sujetos hayan sido retirados del tratamiento del estudio y el 75% de los sujetos en seguimiento de supervivencia hayan fallecido, retirado su consentimiento o hayan sido perdidos para el seguimiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days22
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 57
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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