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    Summary
    EudraCT Number:2016-002365-63
    Sponsor's Protocol Code Number:GS-US-350-1937
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-01
    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 number2016-002365-63
    A.3Full title of the trial
    A Phase 1b Study Followed by an Open label, Parallel, Randomized Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of GS-5829 in Combination with Exemestane or Fulvestrant Comparing
    with Exemestane or Fulvestrant Alone in Subjects with Advanced Estrogen Receptor Positive HER2- Breast Cancer
    Estudio de fase 1b seguido de un estudio aleatorizado de fase 2 con grupos paralelos, abierto, para evaluar la seguridad, tolerabilidad y eficacia de GS-5829 en combinación con exemestano o fulvestrant en comparación con exemestano o fulvestrant solos en pacientes con cáncer de mama avanzado receptor de estrógeno positivo y HER2-
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to asses the safety and effectiveness of a new drug in combination with exemestane or fulvestrant vs exemestane or fulvestrant alone in patients with advanced estrogen receptor positive HER2- breast cancer
    Un estudio de investigación para evaluar la seguridad y la eficacia de un nuevo fármaco en combinación con exemestano o fulvestrant en comparación con exemestano o fulvestrant solos en pacientes con cáncer de de mama avanzado receptor de estrógeno positivo y HER2-
    A.4.1Sponsor's protocol code numberGS-US-350-1937
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02983604
    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 SponsorGilead Sciences, Inc.
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0034913789830
    B.5.5Fax number00441223897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GS-5829
    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 INNGS-5829
    D.3.9.2Current sponsor codeGS-5829
    D.3.9.4EV Substance CodeSUB182004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GS-5829
    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 INNGS-5829
    D.3.9.2Current sponsor codeGS-5829
    D.3.9.4EV Substance CodeSUB182004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Advanced Estrogen Receptor Positive HER2-Breast Cancer
    Cáncer de mama avanzado receptor de estrógeno positivo y HER2-
    E.1.1.1Medical condition in easily understood language
    Advanced Estrogen Receptor Positive HER2-Breast Cancer
    Cáncer de mama avanzado receptor de estrógeno positivo y HER2-
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    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
    Dose Escalation: Characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive Her2-negative breast cancer (ER+/HER2- BrCa); determine the MTD or the recommended Phase 2 dose (RP2D) of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced ER+/HER2- BrCa.
    Dose Expansion: Evaluate the efficacy of GS-5829 in combination with exemestane compared to exemestane alone in subjects with advanced ER+/HER2- BrCa; evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in subjects with advanced ER+/HER2- BrCa.
    Incremento de la dosis: Caracterizar la seguridad y la tolerabilidad de GS-5829 en combinación con exemestano o fulvestrant en pacientes con cáncer de mama avanzado receptor de estrógeno positivo y HER2 negativo (CM RE+/HER2-); determinar la dosis máxima tolerable (DMT), si no se ha determinado ya en el estudio GS-US-350-1599, o la dosis de fase 2 recomendada (DF2R) de GS-5829 en combinación con exemestano o fulvestrant en pacientes con CM RE+/HER2- avanzado.
    Expansión de la dosis: Evaluar la eficacia de GS-5829 en combinación con exemestano en comparación con exemestano solo en pacientes con CM RE+/HER2- avanzado, medida mediante la supervivencia sin progresión (SSP); evaluar la eficacia de GS-5829 en combinación con fulvestrant en comparación con fulvestrant solo en pacientes con CM RE+/HER2- avanzado, medida mediante la SSP.
    E.2.2Secondary objectives of the trial
    Dose Escalation: Evaluate the pharmacokinetics PK of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced ER+/HER2- BrCa.
    Dose Expansion: Evaluate the efficacy of GS-5829 in combination with exemestane compared to exemestane alone in subjects with advanced ER+/HER2- BrCa.
    Evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in subjects with advanced ER+/HER2- BrCa.
    Evaluate the safety and tolerability of GS-5829 in combination with exemestane compared to exemestane alone in subjects with advanced ER+/HER2- BrCa.
    Evaluate the safety and tolerability of GS-5829 in combination with fulvestrant compared to fulvestrant alone in subjects with advanced ER+/HER2- BrCa.
    To evaluate the overall survival (OS) for subjects with advanced ER+/HER2-BrCa who receive GS-5829 in combination with exemestane or fulvestrant comparing to exemestane or fulvestrant alone.
    Incremento de la dosis: Evaluar la farmacocinética (FC) de GS-5829 en combinación con exemestano o fulvestrant en pacientes con CM RE+/HER2- avanzado
    Expansión de la dosis: Evaluar la eficacia de GS-5829 en combinación con exemestano en comparación con exemestano solo en pacientes con CM RE+/HER2- avanzado.
    Evaluar la eficacia de GS-5829 en combinación con fulvestrant en comparación con fulvestrant solo en pacientes con CM RE+/HER2- avanzado.
    Evaluar la seguridad y la tolerabilidad de GS-5829 en combinación con exemestano en comparación con exemestano solo en pacientes con CM RE+/HER2- avanzado.
    Evaluar la seguridad y la tolerabilidad de GS-5829 en combinación con fulvestrant en comparación con fulvestrant solo en pacientes con CM RE+/HER2- avanzado.
    Evaluar la supervivencia global (SG) de pacientes con CM RE+/HER2- avanzado que reciben GS-5829 en combinación con exemestano o fulvestrant en comparación con exemestano o fulvestrant solos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) ≥ 18 years of age, female
    2) Histologically or cytologically confirmed breast cancer with evidence of metastatic or locally
    advanced disease not amenable to resection or radiation therapy with curative intent and who
    have progressed during treatment with at least one prior hormonal therapy
    3) Documentation of ER positive based on the most recent tumor biopsy, unless bone-only disease.
    4) Documented HER2-negative tumor based on local testing on most recent tumor biopsy
    5) Post -menopausal subjects considered to be in the post-menopausal state as defined in the protocol
    6) Measurable disease defined per RECIST v. 1.1 or bone-only disease must have a lytic or
    mixed lytic blastic lesion that can be accurately assessed by CT or MRI. Subjects with bone-only disease and blastic-only metastases are not eligible
    7) All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of
    study drug dosing
    8) Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
    9) Life expectancy of ≥ 3 months, in the opinion of the investigator
    10) Adequate organ function
    11) Coagulation: International Normalized Ratio (INR) ≤ 1.2
    12) Negative serum pregnancy test
    13) Female subjects of childbearing potential who engage in heterosexual intercourse must agree
    to use protocol specified method(s) of contraception
    14) Females who are nursing must agree to discontinue nursing before the first dose of GS-5829
    15) Able and willing to provide written informed consent to participate in the study
    1) Mujer ≥ 18 años de edad
    2) Cáncer de mama citológica o histológicamente confirmado con evidencia de enfermedad metastásica o localmente avanzada no susceptible de resección o radioterapia con intención curativa y que ha progresado durante al menos un tratamiento hormonal previo.
    3) Documentación de RE positivo según la biopsia más reciente del tumor, a no ser que la enfermedad sea solo ósea
    4) Documentación de tumor HER2 negativo según análisis locales en la biopsia más reciente del tumor
    5) Pacientes posmenopáusicas que se considera que están en estado posmenopáusico según se define en el protocolo
    6) Enfermedad medible definida por RECIST v.1.1 o enfermedad solo ósea con una lesión lítica o blástica lítica mixta que se pueda evaluar con exactitud mediante TAC o RM. Las pacientes con enfermedad solo ósea y metástasis solo blásticas no son aptas
    7) Todos los efectos tóxicos agudos de cualquier tratamiento antineoplásico previo se resolvieron hasta el grado ≤1 antes del inicio de la administración del fármaco del estudio
    8) Estado funcional del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) ≤1
    9) Esperanza de vida de ≥3 meses, en opinión del investigador
    10) Función orgánica adecuada
    11) Coagulación: Razón normalizada internacional (RNI) ≤1,2
    12) Prueba de embarazo en suero negativa
    13) Las pacientes en edad fértil que mantengan relaciones heterosexuales deben aceptar utilizar los métodos anticonceptivos especificados en el protocolo
    14) Las mujeres que estén amamantando deben aceptar interrumpir la lactancia antes de la primera dosis de GS-5829
    15) Capaces y dispuestas a dar su consentimiento informado por escrito para participar en el estudio
    E.4Principal exclusion criteria
    1) History or evidence of clinically significant disorder, condition, or disease that, in the opinion
    of the investigator or the Gilead medical monitor would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
    2) Known brain metastasis or leptomeningeal disease
    3) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection,
    active or chronic bleeding event within 28 days prior to first dose of study drug, uncontrolled
    cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
    4) Myocardial infarction, symptomatic congestive heart failure , unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of C1D1
    5) Major surgery, defined as any surgical procedure that involves general anesthesia and a
    significant incision within 28 days of the first dose of study drug
    6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the
    absorption of GS-5829, including any unresolved nausea, vomiting, or diarrhea that is CTCAE Grade > 1
    7) Minor surgical procedure(s) within 7 days of enrollment or randomization, or not yet recovered from prior surgery
    8) History of a concurrent or second malignancy, except for: adequately treated local basal cell
    or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder
    cancer; adequately treated Stage 1 or 2 cancer currently in complete remission; any other
    cancer that has been in complete remission for ≥ 5 years
    9) Anti-tumor therapy within 21 days of study drug dosing ; 5 half-lives of any investigational drug;
    concurrent use of goserelin for pre-/peri-menopausal breast cancer and exemestane or
    fulvestrant per the protocol are permitted
    10) History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia
    method) at screening is prolonged (> 470 ms). Subjects who screen fail due to this criterion
    are not eligible to be re-screened
    11) Prior exposure to any bromodomain (BET) inhibitors
    12) Immunotherapy within 6 months of C1D1
    13) Evidence of bleeding diathesis or clinically significant bleeding, within 28 days of C1D1 or history of hemoptysis of > 2.5mL/1 teaspoon within 6 months of C1D1
    14) Anticoagulation therapy within 7 days of C1D1, including acetylsalicylic acid, low molecular weight heparin, or warfarin
    15) Known human immunodeficiency virus (HIV) infection
    16) Hepatitis B surface Antigen (HBsAg) positive
    17) Hepatitis C virus (HCV) antibody positive with HCV RNA positive
    18) Use of moderate/strong cytochrome P450 (CYP) 3A4 inhibitors or moderate/strong CYP3A4 inducers within 2 weeks prior to the first dose of study drug
    19) History of high grade esophageal or gastric varices
    1) Antecedentes o evidencia de trastorno, afección o enfermedad clínicamente significativos que, en opinión del investigador o del supervisor médico de Gilead, podrían suponer un riesgo para la seguridad de la paciente o interferir con la evaluaciones, los procedimientos o la finalización del estudio
    2) Metástasis cerebral o enfermedad leptomeníngea conocidas
    3) Enfermedad intercurrente no controlada, lo que incluye, entre otros, infección activa no controlada, acontecimiento de hemorragia activa o crónica dentro de los 28 días previos a la primera dosis del fármaco del estudio, arritmia cardiaca no controlada o enfermedad psiquiátrica/situación social que limitaría el cumplimiento de los requisitos del estudio a criterio del médico responsable del tratamiento
    4) Infarto de miocardio, insuficiencia cardiaca congestiva sintomática, angina inestable o arritmia cardiaca grave no controlada en los 6 meses previos al C1D1
    5) Cirugía mayor, definida como cualquier procedimiento quirúrgico que requiera anestesia general y una incisión significativa en los 28 días previos a la primera dosis del fármaco del estudio
    6) Deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de GS-5829, lo que incluye náuseas, vómitos o diarrea sin resolver de grado >1
    7) Procedimientos quirúrgicos menores en los 7 días previos a la inclusión o a la aleatorización, o aún no recuperada de una cirugía previa
    8) Antecedentes de un tumor maligno concurrente o segundo, a excepción de: carcinoma local de células basales o carcinoma de células escamosas de la piel adecuadamente tratados; carcinoma cervical in situ; cáncer superficial de vejiga; cáncer en estadio 1 o 2 adecuadamente tratado actualmente en remisión completa; cualquier otro tipo de cáncer que haya estado en remisión completa durante ≥5 años
    9) Tratamiento antitumoral en los 21 días anteriores a la administración del fármaco del estudio; 5 semividas de cualquier fármaco en investigación; se permite el uso concurrente de goserelina para el cáncer de mama pre/perimenopáusico y exemestano o fulvestrant según el protocolo
    10) Antecedentes de síndrome de QT largo o cuyo intervalo QT corregido (QTc) medido (método de Friedericia) en la selección esté prolongado (>470 ms). Las pacientes que fracasen en la selección debido a este criterio no son aptas para volver a someterse a selección
    11) Exposición previa a algún inhibidor de bromodominio (BET)
    12) Inmunoterapia en los 6 meses anteriores al C1D1
    13) Evidencia de diátesis hemorrágica o hemorragia clínicamente significativa en los 28 días anteriores al C1D1 o antecedentes de hemoptisis de > 2,5 ml/1 cucharadita en los 6 meses anteriores al C1D1
    14) Tratamiento anticoagulante en los 7 días anteriores al C1D1, lo que incluye ácido acetilsalicílico, heparina de bajo peso molecular o warfarina
    15) Infección conocida por el virus de la inmunodeficiencia humana (VIH)
    16) Positivo para el antígeno de superficie del virus de la hepatitis B (HBsAg)
    17) Positivo para anticuerpos del virus de la hepatitis C (VHC) con ARN del VHC
    18) Uso de inhibidores moderados/potentes del citocromo P450 (CYP3A4) o inductores moderados/potentes de CYP3A4 en las 2 semanas previas a la primera dosis del fármaco del estudio
    19) Antecedentes de varices esofágicas o gástricas de alto grado
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation:
    Safety profile and tolerability of the combination of GS-5829 and exemestane or fulvestrant as assessed by the incidence of dose limiting toxicities.

    Dose Expansion:
    PFS.
    Incremento de la dosis:
    Perfil de seguridad y tolerabilidad de la combinación de GS-5829 y exemestano o fulvestrant según la incidencia de toxicidad limitante de dla osis.

    Expansión de la dosis:
    SSP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study visits occur on Days 1 and 15 of cycles 1 and 2., and every 4 weeks thereafter.
    Las visitas del estudio los días 1 y 15 de los ciclos 1 y 2. y cada 4 semanas a partir de entonces.
    E.5.2Secondary end point(s)
    Dose Escalation:
    GS-5829 PK parameters

    Dose Expansion:
    Overall safety profile
    Overall response rate
    Clinical benefit rate
    Overall survival
    Parámetros de FC de GS-5829

    Expansión de dosis:
    Perfil de seguridad general
    Tasa de respuesta global
    Tasa de beneficios clínicos
    Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study visits occur on Days 1 and 15 of cycles 1 and 2., and every 4 weeks thereafter.
    Las visitas del estudio los días 1 y 15 de los ciclos 1 y 2. y cada 4 semanas a partir de entonces.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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
    Dose escalation, dose expansion
    Incremento de la dosis, expansión de la dosis
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Belgium
    France
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study for a subject is defined as the date of the last study-related procedure or the date of death for an on-study subject.
    Fin del estudio de un sujeto se define como la fecha del último procedimiento relacionado con el estudio o la fecha del fallecimiento de un sujeto en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Information not present in EudraCT
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 180
    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)
    After the patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physician.
    Después de que el paciente haya completado o terminado su participación en el estudio, el cuidado a largo plazo del participante seguirá siendo responsabilidad de su médico de cabecera.
    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 Decision2017-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-07-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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