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    EudraCT Number:2016-004276-21
    Sponsor's Protocol Code Number:I3Y-MC-JPCM
    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:2019-01-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-004276-21
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
    Estudio de fase 2, aleatorizado, doble ciego y controlado con placebo de acetato de abiraterona más prednisona con o sin abemaciclib en pacientes con cáncer de próstata metastásico resistente a la castración
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
    Estudio en el que se evalúa el acetato de abiraterona junto con prednisona (con o sin abemaciclib) en pacientes con cáncer de próstata metastásico resistente a la castración
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCM
    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 SponsorLilly S.A.
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Cork Ltd
    B.5.2Functional name of contact pointGennaro De Crescenzo
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, 11 Eastgate Road, Eastgate Business Park
    B.5.3.2Town/ cityLittle Island, Co. Cork
    B.5.3.3Post codeT45 KD39
    B.5.4Telephone number003491836 2958
    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 nameabemaciclib
    D.3.2Product code LY2835219
    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 INNabemaciclib
    D.3.9.2Current sponsor codeLY2835219
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Castration-Resistant Prostate Cancer
    Cáncer de próstata metastásico resistente a la castración
    E.1.1.1Medical condition in easily understood language
    Prostate cancer that has spread beyond the prostate and that keeps growing despite of castration
    Cáncer de próstata que se ha extendido más allá de esta y que continúa creciendo a pesar de la castración.
    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 10036909
    E.1.2Term Prostate cancer metastatic
    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 LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate 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
    Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with abiaterone acetate and prednisone.
    Part 1&2:
    To compare the rPFS of patients receiving abiraterone acetate plus prednisone with or without abemaciclib.
    To compare the time to PSA progression in patients receiving abiraterone acetate plus prednisone with or without abemaciclib.
    Parte 1: determinar la DRF2 de abemaciclib que pueda administrarse de forma segura a pacientes con CPRC en combinación con acetato de abiraterona y
    prednisona. Partes 1 y 2: Comparar la supervivencia sin progresión radiológica (SSPr) en los pacientes que reciban acetato de abiraterona y prednisona (con o sin abemaciclib). Comparar el tiempo transcurrido hasta la progresión según los valores del PSA en los pacientes que reciban acetato de
    biraterona y prednisona (con o sin abemaciclib).
    E.2.2Secondary objectives of the trial
    To characterize further the safety profile of the combination of abemaciclib and abiraterone acetate plus prednisone.
    To compare the efficacy in patients receiving abiraterone acetate plus prednisone with or without abemaciclib.
    Time to Symptomatic Progression
    To characterize the PK of abemaciclib and abiraterone acetate when administered in combination
    Caracterizar en mayor medida el perfil de seguridad de la politerapia con abemaciclib, acetato de abiraterona y prednisona. Comparar la eficacia en pacientes que reciban acetato de abiraterona y prednisona (con o sin abemaciclib).
    Tiempo transcurrido hasta la progresión sintomática Caracterizar la farmacocinética de abemaciclib y el acetato de abiraterona cuando se administran en combinación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Male patients, 18 years of age or greater; willing and able to provide written informed consent.
    [2] Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
    [3] Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI). If lymph node metastasis is the only evidence of metastasis, it must be ≥1.5cm in the short axis. Visceral metastasis, including to liver, is allowed.
    [4] Serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the Screening visit. Patients who have not undergone orchiectomy are required to continue androgen-deprivation therapy (LHRH agonists/antagonists) throughout the study.
    [5] Progressive disease at study entry demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy defined as one or more of the following criteria:
    •Sequence of at least 2 rising PSA values at a minimum of 1-week intervals with the last result being at least 1.0 ng/ml if confirmed rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide).
    •Radiographic progression per RECIST1.1 for soft tissue and/or per PCWG3 for bone, with or without PSA progression.
    [6] Patient must have discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment), must have recovered from of all acute toxic effects of prior therapy or surgical procedure to Grade ≤ 1 or baseline (as per Common Terminology Criteria for Adverse Events 4.0) prior to randomization, with the exception of alopecia or peripheral neuropathy AND have a washout period from last dose of prior systemic or radiation therapy.
    [7] Must be able and willing to undergo mandatory tumor biopsy of at least one metastatic site which will be collected following determination of eligibility and before initiating study treatment.
    [8] Have adequate organ function.
    [9] Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
    [10] Willing to comply with study procedures, able to swallow large capsules. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 3 months following the last dose of study treatment.
    [1] Varones de al menos 18 años, capaces de proporcionar el consentimiento informado por escrito y dispuestos a ello.
    [2] Adenocarcinoma de páncreas confirmado histológicamente sin diferenciación neuroendocrina ni características histológicas de células microcíticas.
    [3] Cáncer de próstata metastásico documentado de acuerdo con los resultados de una gammagrafía ósea o lesiones metastásicas mensurables en las partes blandas mediante tomografía axial computarizada (TAC) o resonancia magnética nuclear (RMN). Si el único indicio de metástasis se observa en un ganglio linfático, el eje más corto debe ser de al menos 1,5 cm. Se permite la presencia de metástasis viscerales (incluso en el hígado).
    [4] Concentración sérica de testosterona #1,73 nmol/l (50 ng/dl) en la visita de selección. Los pacientes que no se hayan sometido a una orquiectomía deben continuar con un tratamiento de privación androgénica (agonistas/antagonistas de la LHRH) a lo largo del estudio.
    [5] Progresión de la enfermedad en el momento de la inclusión en el estudio, confirmada durante el tratamiento continuo de privación androgénica (TPA) o después de la orquiectomía en función de uno o más de uno de los criterios siguientes:
    •Serie de al menos 2 valores crecientes del PSA. Entre la determinación de uno y otro debe haber transcurrido al menos 1 semana y el resultado más reciente debe ser al menos de 1,0 ng/ml si la elevación confirmada es el único signo de progresión. Los pacientes que hayan recibido un antiandrógeno deben presentar progresión de acuerdo con los valores del PSA tras la retirada (#4 semanas desde la última administración de
    flutamida o #6 semanas desde la última administración de bicalutamida o nilutamida).
    •Progresión radiológica en las partes blandas (de acuerdo con los criterios RECIST 1.1) y/o el hueso (de acuerdo con los criterios PCWG3), con o sin progresión de acuerdo con los valores del PSA.
    [6] El paciente debe haber interrumpido todos los tratamientos antineoplásicos anteriores (salvo los tratamientos de privación androgénica y los que evitan la disminución de la densidad ósea), debe haberse recuperado de todos los efectos tóxicos inmediatos de los tratamientos o intervenciones quirúrgicas anteriores, esto es, que se resuelvan a un grado #1 o retornen a la situación inicial (CTCAE 4.0) antes de la aleatorización (salvo en caso de alopecia o neuropatía periférica) Y haber completado un período de reposo farmacológico desde la última dosis del tratamiento sistémico o radioterapia previos.
    [7] Debe ser capaz de someterse a una biopsia tumoral obligatoria de al menos una localización metastásica y estar dispuesto a que se le realice; esta se llevará a cabo una vez que se haya determinado su idoneidad para participar y antes del inicio del tratamiento del estudio.
    [8] Presentar una función orgánica aceptable.
    [9] Presentar una categoría funcional del Eastern Cooperative Oncology Group (ECOG) de 0-1.
    [10] Estar dispuesto a cumplir los procedimientos del estudio y ser capaz de tragar cápsulas grandes. Los pacientes fértiles deben estar de acuerdo en utilizar métodos anticonceptivos eficaces y no donar esperma durante el estudio y al menos durante los 3 meses posteriores a la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    [11] Prior therapy with CYP17 inhibitors (including abiraterone acetate, TAK-700, TOK-001 and ketoconazole)
    [12] Prior treatment with abemaciclib or any CDK4 & 6 inhibitors
    [13] Known or suspected contraindications or hypersensitivity to abiraterone acetate, prednisone or abemaciclib or to any of the excipients.
    [14] Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (patients treated with docetaxel in the mHSPC are eligible), prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, sipuleucel-T. Patients who had prior radiation or surgery to all target lesions.
    [15] Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. Have participated in clinical trial for which treatment assignment is still blinded. If patient has participated in a clinical study involving an investigational product, 3 months or 5 half-lives (whichever is longer) should have passed. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Lilly clinical research physician (CRP) is required to establish eligibility.
    [16] Gastrointestinal disorder affecting absorption or inability to swallow large pills
    [17] Have prior malignancies or active concurrent malignancy (with the exception of non-melanomatous skin cancer). Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low, as judged by the Lilly CRP, are eligible for this study. The Lilly CRP will approve enrollment of patients with prior malignancies in remission before these patients are enrolled.
    [18] The patient has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
    [19] The patient has an history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy.
    [20] Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart failure or cardiac ejection fraction measurement of < 50% at baseline.
    [21] Patients with clinically active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C), ascites or bleeding disorders secondary to hepatic dysfunction.
    [22] History of adrenal dysfunction
    [23] The patient has active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment
    [24] Known or suspected CNS metastatic disease (Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement).
    [25] Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
    [26] Life expectancy < 6 months
    [27] Patient treated with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication at least five half-lives prior to starting study drug.
    [28] Have received recent (within 4 weeks prior to randomization) live vaccination. Seasonal flu vaccines that do not contain a live virus are permitted.
    [29] Untreated spinal cord compression or evidence of spinal metastases with risk of spinal compression. Structurally unstable bone lesions suggesting impending fracture.
    11Ttos anteriores con inhibidores del CYP17(incluidos acetato de abiraterona,TAK-700,TOK-001 y ketoconazol) 12Tto anterior con abemaciclib o cualquier inhibidor de la CDK4 y la CDK6 13Contraindicaciones o hipersensibilidades confirmadas o sospechadas al acetato de abiraterona,la prednisona o al abemaciclib o a cualquiera de sus excipientes 14Quimioterapia citotóxica previa para el cáncer de próstata resistente a la castración(pueden participar los pacientes con cáncer de próstata metastásico sensible a las hormonas q hayan recibido docetaxel)radiofármacos previos para el cáncer de próstata o tto previo con enzalutamida, apalutamida,sipuleucel-T.Pacientes en los q todas las lesiones diana se hayan tratado con radioterapia o cirugía 15Participar en la actualidad en un EC en el q se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica q se considere incompatible con el estudio desde un punto de vista científico o médico.Haber participado en un ec
    cuya asignación de tto aún esté enmascarada.Si un paciente ha participado en un estudio clínico con un producto en fase d investigación,deben haber transcurrido 3 meses o 5 semividas(el período más prolongado).Si el paciente participa en la actualidad en un ensayo clínico en el q se haga un uso no recogido en ficha técnica d un producto sanitario,el investigador y el médico d investigación clínica(CRP)de Lilly deberán determinar conjuntamente su idoneidad para participar 16Trastorno gastrointestinal q afecte la absorción o incapacidad para tragar píldoras de gran tamaño 17Haber presentado neoplasias malignas o presentar en la actualidad neoplasias malignas activas simultáneas(salvo los casos de cáncer d piel no
    melanomatoso)Podrán participar en este estudio los pacientes con carcinoma in situ de cualquier origen y los pacientes q anteriormente hayan experimentado otras neoplasias malignas,estén en remisión y presenten una baja probabilidad d recurrencia de acuerdo con el criterio del médico de investigación clínica d Lilly(CRP).El CRP d Lilly deberá aprobar el reclutamiento de los pacientes con neoplasias malignas previas y q estén en remisión, antes de q estos sean reclutados 18Que el paciente presente enfermedades preexistentes graves q,en opinión del investigador,pudieran impedir su participación en este estudio(x ej,enfermedad pulmonar intersticial,disnea grave en reposo o q requiera oxigenoterapia,antecedentes de resección quirúrgica importante con afectación del estómago o el intestino delgado,enfermedad de Crohn preexistente,colitis ulcerosa o enfermedad crónica preexistente q haga q el paciente presente diarrea d grado#2 en el período inicial) 19Antecedentes de cualquiera de las siguientes enfermedades:síncope de origen cardiovascular;arritmia ventricular de origen patológico(entre otras,taquicardia ventricular y fibrilación ventricular)o paro cardiaco súbito.Fibrilación auricular u otras arritmias cardiacas q requieran tto. 20Cardiopatía de trascendencia clínica de acuerdo con antecedentes de infarto de miocardio,o episodios trombóticos arteriales en los últimos 6 meses,angina de pecho grave o inestable,o insuficiencia cardíaca de clase II-IV según la NYHA o fracción d expulsión cardíaca <50 % en el período inicial 21Pacientes con hepatopatías clínicamente activas o crónicas,disfunción hepática moderada/intensa(clase B y C d Child-Pugh),ascitis o trastornos hemorrágicos asociados con la disfunción hepática
    22Antecedentes de disfunción suprarrenal 23Presentar una infección bacteriana activa(esto es,q requiera la administración d antibióticos x vía intravenosaen el momento en el q se inicie el tto. del estudio),micosis o infección vírica detectable(p.ej.,virus de la inmunodeficiencia humana o hepatitis B o C activa[p.ej.presencia del antígeno de superficie del virus d la hepatitis B])No se necesitan pruebas d cribado para el reclutamiento del paciente 24Cáncer
    metastásico en el SNC confirmado o sospechado(no se necesitan pruebas de
    cribado de metástasis en el SNC,a menos q haya signos o síntomas d afectación)
    25Hipertensión sin controlar(presión arterial sistólica #160 mmHg o PA diastólica
    #95 mmHg)Los pacientes con antecedentes de hipertensión pueden participar
    siempre q la tensión arterial esté controlada con tto. antihipertensivo 26Esperanza
    de vida<6 meses 27Pacientes q reciban inhibidores o inductores potentes d la
    isoenzima CYP3A y cuyo tto. no pueda interrumpirse o cambiarse a otro
    medicamento diferente al menos 5 semividas antes del comienzo de la
    administración del fármaco del estudio 28Haber recibido recientemente(en el
    transcurso de las 4 semanas anteriores a la aleatorización)una vacuna elaborada
    con microbios vivos.Se permite la administración de vacunas contra la gripe
    estacional q no contengan virus vivos 29Compresión medular sin tratar o signos de
    metástasis en la médula ósea con riesgo de comprensión medular.Lesiones óseas
    estructuralmente inestables indicativas de fractura inminente
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities
    Part 1 & 2: rPFS; Time to PSA progression
    Parte 1: seguridad (entre otros parámetros): AAST, AAG, muertes y resultados anómalos en los análisis clínicos Partes 1 y 2: SSPr; tiempo transcurrido hasta que la progresión según los valores del PSA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluations will occur at each study visit.
    Radiologic assessment every 8 weeks for the first 24 weeks, every 12 weeks thereafter, and within 14 days of symptomatic progression if no radiographic progression yet.
    Parte 1: seguridad (entre otros parámetros): AAST, AAG, muertes y resultados anómalos en los análisis clínicos Partes 1 y 2: SSPr; tiempo transcurrido hasta que la progresión según los valores del PSA
    E.5.2Secondary end point(s)
    The safety endpoints evaluated will include but are not limited to the following: AEs, TEAEs, SAEs, clinical laboratory tests, ECGs, vital signs, and physical examinations.
    • ORR and DoR
    • OS
    Time from randomization to any of the following (whichever occurs earlier):
    - Symptomatic Skeletal Event (SSE)
    - Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy
    - Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy
    Abemaciclib and abiraterone acetate steady state plasma concentrations.
    Entre los criterios de valoración de la seguridad que se evaluarán se incluyen los siguientes: AA, AAST, AAG, resultados de los análisis clínicos, ECG, constantes vitales y exploraciones físicas. • TGR y DdR • SG Tiempo transcurrido desde la aleatorización hasta cualquiera de los siguientes (lo que acontezca antes): - Acontecimiento de tipo esquelético (ATE) - Síntomas relacionados con la progresión del dolor o el empeoramiento de la enfermedad que requieran un nuevo tratamiento antineoplásico sistémico. - Desarrollo de síntomas de trascendencia clínica por la progresión tumoral locorregional que requieran una intervención quirúrgica o radioterapia. Concentraciones plasmáticas de abemaciclib y acetato de abiraterona en situación de equilibrio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety evaluations will occur at each study visit.
    Radiologic assessment every 8 weeks for the first 24 weeks, every 12 weeks thereafter, and within 14 days of symptomatic progression if no radiographic progression yet.
    Las evaluaciones de la seguridad se realizarán en cada visita del estudio. Las evaluaciones radiológicas se realizarán cada 8 semanas durante las primeras 24 semanas; después, cada 12 semanas y en el transcurso de los 14 días posteriores a la progresión sintomática si el paciente aún no ha presentado progresión radiológica.
    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 Yes
    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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    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
    LPLV: date of the last visit or last scheduled procedure for the last patient
    UVUP: fecha de la última visita o del último procedimiento programado para el
    último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female No
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    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)
    Patients who are discontinued from the study will have follow-up procedures. Patients receiving post-study-treatment-discontinuation anticancer therapies will be provided by type of therapy (surgery, radiotherapy, or systemic therapy), and by drug class and/or name, overall and by line of therapy.
    Los pacientes que dejen de participar en el estudio realizarán los procedimientos de seguimiento. Se presentará a los pacientes que reciban tratamientos antineoplásicos tras la interrupción del tratamiento del estudio en función del tipo de tratamiento (cirugía, radioterapia o tratamiento sistémico), la clase de fármacos y/o el nombre, en su conjunto y por línea de tratamiento.
    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 Decision2019-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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