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    Summary
    EudraCT Number:2020-006063-28
    Sponsor's Protocol Code Number:SHR3162-III-305
    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:2021-06-23
    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 number2020-006063-28
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P as First-Line Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer
    Estudio en fase III multicéntrico, aleatorizado, doble ciego y controlado con placebo de fuzuloparib combinado con acetato de abiraterona y prednisona (AA-P) frente a placebo combinado con AA-P como tratamiento de primera línea en pacientes con cáncer de próstata resistente a la castración metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An International, Randomized, Double-Blind, Phase III Study of Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P as First-Line Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer
    Estudio en fase III multicéntrico, aleatorizado, doble ciego y controlado con placebo de fuzuloparib combinado con acetato de abiraterona y prednisona (AA-P) frente a placebo combinado con AA-P como tratamiento de primera línea en pacientes con cáncer de próstata resistente a la castración metastásico
    A.4.1Sponsor's protocol code numberSHR3162-III-305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04691804
    A.5.4Other Identifiers
    Name:INDNumber:154746
    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 SponsorJiangsu Hengrui Medicine Co., Ltd
    B.1.3.4CountryChina
    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 supportJiangsu Hengrui Medicine Co., Ltd
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJiangsu Hengrui Medicine Co., Ltd
    B.5.2Functional name of contact pointChunlei Jin, M.D
    B.5.3 Address:
    B.5.3.1Street AddressNo. 7 Kunlunshan Road, Economic and Technological Development Zone
    B.5.3.2Town/ cityLianyungang, Jiangsu
    B.5.3.3Post code222047
    B.5.3.4CountryChina
    B.5.4Telephone number8618036618579
    B.5.6E-mailchunlei.jin@hengrui.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 nameFuzuloparib
    D.3.2Product code SHR3162
    D.3.4Pharmaceutical form Capsule
    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 INNFuzuloparib
    D.3.9.1CAS number 1358715-18-0
    D.3.9.2Current sponsor codeSHR3162
    D.3.9.3Other descriptive nameFluzoparib
    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.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 Prednison acis
    D.2.1.1.2Name of the Marketing Authorisation holderacis Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form 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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    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.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 Zytica
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical 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 INNabiraterone acetate
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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 resistente a la castración metastásico
    E.1.1.1Medical condition in easily understood language
    Metastatic Castration-Resistant Prostate Cancer
    cáncer de próstata resistente a la castración metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term 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
    - To evaluate whether fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects unselected for DRD status (Cohort 1)

    - To evaluate whether fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2)
    - Evaluar si fuzuloparib más AA-P es superior a placebo más AA-P como tratamiento de primera línea mediante la evaluación de la SSPr en sujetos con CPRCm no seleccionados en función del estado DRD (cohorte 1).
    - Evaluar si fuzuloparib más AA-P es superior a placebo más AA-P como tratamiento de primera línea mediante la evaluación de la SSPr en sujetos con CPRCm que albergan DRD (cohorte 2).
    E.2.2Secondary objectives of the trial
    To evaluate the OS in unselected mCRPC subjects (Cohort 1) and in mCRPC subjects harboring DRD (Cohort 2), respectively.
    Evaluar la SG en sujetos con CPRCm no seleccionados (cohorte 1) y en sujetos con CPRCm que albergan DRD (cohorte 2), respectivamente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age of ≥ 18 years old.
    2) A score of 0 to 1 for ECOG performance status.
    3) Expected survival of ≥ 6 months.
    4) Prostate adenocarcinoma confirmed by histology or cytology examinations, with no indication of neuroendocrine differentiation or small cell characteristics.
    5) Metastatic lesions with imaging evidence.
    6) Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy. See the disease progression at study entry definition in the protocol.
    7) Continuous treatment with luteinizing hormone-releasing hormone analogue (LHRHa) (drug-induced castration) or previous bilateral orchidectomy (surgical castration); subjects who have not undergone bilateral orchidectomy must plan to maintain effective LHRHa treatment within 4 weeks prior to the randomization of this study and throughout the entire study.
    8) Testosterone is at the castration level (≤ 50 ng/dL or 1.73 nmol/L) during screening.
    9) Blood and tumor tissue samples (tumor sample is optional) are provided during screening to determine the DRD status; subjects in Cohort 2 must be DRD positive.
    10) The functional level of the organs must meet the requirements (no blood transfusion or treatment with hematopoietic growth factor within 2 weeks prior to routine blood screening) as detailed in the protocol.
    11) For patients who are judged by the investigator as having the ability to ejaculate and who are sexually active must agree to take effective contraceptive measures and not to donate sperm from the first dose to 3 months after the last dose of study treatment.
    12) Participate in this clinical trial voluntarily, understand and have signed the informed consent.
    1) Edad ≥18 años.
    2) Puntuación de 0 a 1 del estado funcional según la escala ECOG.
    3) Supervivencia esperada de ≥6 meses.
    4) Adenocarcinoma de próstata confirmado mediante exploraciones histológicas o citológicas, sin indicación de diferenciación neuroendocrina ni características de células pequeñas.
    5) Lesiones metastásicas con evidencia de imágenes diagnósticas.
    6) Progresión de la enfermedad de cáncer de próstata metastásico mientras el sujeto estaba recibiendo tratamiento de supresión androgénica. Vea la definición de progresión de la enfermedad al entrar en el estudio en el protocolo.
    7) Tratamiento continuo con un análogo de la hormona liberadora de la hormona luteinizante (aHLHL) (castración inducida por fármacos) u orquiectomía bilateral previa (castración quirúrgica); los sujetos que no se hayan sometido a orquiectomía bilateral deben planear mantener un tratamiento eficaz con aHLHL en las 4 semanas previas a la aleatorización de este estudio y a lo largo de todo el estudio.
    8) El nivel de testosterona está en el nivel de castración (≤50 ng/dl o 1,73 nmol/l) durante la selección.
    9) Las muestras de sangre y tejido tumoral (la muestra tumoral es opcional) se proporcionan durante la selección para determinar el estado de DRD; los sujetos de la cohorte 2 deben ser positivos para DRD.
    10) El nivel funcional de los órganos debe cumplir los requisitos (sin transfusión de sangre ni tratamiento con factor de crecimiento hematopoyético en las 2 semanas previas al análisis de sangre rutinario) según se detallan en el protocolo.
    11) Los pacientes que el investigador considere que tienen la capacidad de eyacular y que son sexualmente activos, deben aceptar tomar medidas anticonceptivas eficaces y no donar esperma desde la primera dosis hasta 3 meses después de la última dosis del tratamiento del estudio.
    12) Participar en este ensayo clínico voluntariamente, comprender y haber firmado el consentimiento informado.
    E.4Principal exclusion criteria
    1) Prior treatment with any PARP inhibitor.
    2) Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC (nmCRPC) stage, including chemotherapy, immunotherapy, abiraterone acetate or other CYP17 inhibitors, novel AR antagonists (such as enzalutamide, apalutamide, darolutamide, SHR3680, and proxalutamide) and other molecular targeted therapies. See protocol for the allowed exceptions.
    3) With severe bone injury caused by bone metastasis of prostate cancer as judged by the investigator, including poorly controlled severe bone pain, and pathological fractures and spinal cord compressions that have occurred in the last 6 months before the first dose or are expected to occur soon.
    4) Radiotherapy or major surgery within 3 weeks before the first dose, or participation in other drug clinical trials within 4 weeks or 5 half-lives, whichever is longer, prior to start of this study drug at day 1 (C1D1).
    5) Have used any strong/moderate CYP3A4 inducers or inhibitors within 14 days prior to the first dose.
    6) The use of drugs that may affect P-gp cannot be interrupted during the study.
    7) Plan to receive any other anti-tumor treatment during the study treatment of this study.
    8) Presence of radiologically confirmed tumor lesions in the brain.
    9) Contraindications to the use of prednisone (corticosteroids), such as active infections or other medical conditions.
    10) Any chronic medical conditions that require a dose of corticosteroid ≥ 5 mg prednisone BID.
    11) History of uncontrolled pituitary or adrenal dysfunction.
    12) Uncontrolled hypertension (persistent systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg). Subjects with a history of hypertension are allowed to participate in the study if their blood pressure can be effectively controlled by antihypertensive therapy.
    13) Presence of active heart diseases (including severe/unstable angina pectoris, symptomatic congestive heart failure of NYHA Class III or IV, left ventricular ejection fraction < 50%, and ventricular arrhythmia requiring drug therapy) or a history of arterial or venous thrombosis (including pulmonary embolism and cerebrovascular accident) within 6 months, or myocardial infarction within 12 months prior to the first dose.
    14) History of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or a history of other malignant tumors within 5 years prior to the first dose (except carcinoma in situ that has been completely relieved and the malignant tumor that is judged by investigators as slowly progressive).
    15) Active HBV or HCV infection (HBsAg positive with virus copy ≥ 500 IU/mL, HCV antibody positive with HCV RNA higher than the lower limit of detection of the analytical method).
    16) Human immunodeficiency virus-positive subjects with 1 or more of the following:
    - Not receiving highly active antiretroviral therapy.
    - Had a change in antiretroviral therapy within 6 months of the start of screening.
    - Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment).
    - CD4 count < 350/mm3 at screening.
    - AIDS-defining opportunistic infection within 12 months of start of screening.
    17) Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
    18) With known allergy or intolerance to fuzuloparib, abiraterone acetate, prednisone, or their excipients.
    19) Confirmed SARS-CoV-2 (COVID-19) infection (validated test positive), or suspected COVID-19 infection (clinical symptoms without documented test results), or close contact with a person with known or suspected COVID-19 infection, within 4 weeks before the first dose. The subject may be included with a documented negative result for a validated COVID-19 test.
    20) Presence of concomitant diseases (such as severe diabetes mellitus, thyroid disorder, and psychiatric disorders) or any other situation that may pose serious risks to the safety of the subjects or may affect their ability to complete the study as judged by the investigator.
    1) Tratamiento previo con cualquier inhibidor de PARP.
    2) Haber recibido cualquier tratamiento antineoplásico sistémico durante el estadio de CPRCm o el estadio de CPRC no metastásico (CPRCnm), incluidos quimioterapia, inmunoterapia, acetato de abiraterona u otros inhibidores de CYP17, nuevos antagonistas del receptor de andrógenos (RA) (como enzalutamida, apalutamida, darolutamida, SHR3680 y proxalutamida) y otros tratamientos moleculares dirigidos. Ver el protocolo para las excepciones permitidas.
    3) Con lesión ósea grave causada por metástasis ósea del cáncer de próstata según el criterio del investigador, incluido dolor óseo intenso mal controlado, fracturas patológicas y compresiones de la médula espinal que se han producido en los últimos 6 meses antes de la primera dosis o que se espera que ocurran en un futuro próximo.
    4) Radioterapia o cirugía mayor en las 3 semanas anteriores a la primera dosis O participación en otros ensayos clínicos con fármacos en las 4 semanas o 5 semividas, lo que sea más largo, antes del inicio de este fármaco del estudio el día 1 (D1C1).
    5) Haber utilizado cualquier inductor o inhibidor potente/moderado de CYP3A4 en los 14 días anteriores a la primera dosis.
    6) Los medicamentos que pueden afectar a la P-glicoproteína no pueden interrumpirse durante el estudio.
    7) Tener previsto recibir cualquier otro tratamiento antitumoral durante el tratamiento de este estudio.
    8) Presencia de lesiones tumorales confirmadas radiológicamente en el cerebro.
    9) Contraindicaciones al uso de prednisona (corticosteroides), como infecciones activas u otras afecciones médicas.
    10) Cualquier afección médica crónica que requiera una dosis de corticosteroides ≥5 mg de prednisona 2 v/d.
    11) Antecedentes de disfunción hipofisaria o suprarrenal no controlada.
    12) Hipertensión no controlada (presión arterial sistólica ≥160 mmHg o presión arterial diastólica ≥100 mmHg persistentes). Los sujetos con antecedentes de hipertensión pueden participar en el estudio si su presión arterial puede controlarse eficazmente con un tratamiento antihipertensivo.
    13) Presencia de cardiopatías activas (incluidas angina de pecho grave/inestable, insuficiencia cardíaca congestiva sintomática de clase III o IV de la NYHA, fracción de eyección ventricular izquierda <50 % y arritmia ventricular que requiere tratamiento farmacológico) o antecedentes de trombosis arterial o venosa (incluidas embolia pulmonar y accidente cerebrovascular) en los 6 meses anteriores o infarto de miocardio en los 12 meses anteriores a la primera dosis.
    14) Antecedentes de síndrome mielodisplásico (SMD)/leucemia mieloide aguda (LMA) o antecedentes de otros tumores malignos en los 5 años anteriores a la primera dosis (excepto carcinoma in situ que se haya aliviado completamente y el tumor maligno que los investigadores consideren de progresión lenta);
    15) Infección activa por VHB o VHC (positivo para HBsAg con copia del virus ≥500 UI/ml, positivo para anticuerpos contra el VHC con ARN del VHC superior al límite inferior de detección del método analítico).
    16) Sujetos positivos para el virus de la inmunodeficiencia humana con 1 o más de los siguientes:
    - No recibir tratamiento antirretroviral altamente activo.
    - Haber tenido un cambio en el tratamiento antirretroviral en los 6 meses anteriores al inicio de la selección.
    - Recibir tratamiento antirretroviral que pueda interferir con el fármaco del estudio (consultar al promotor para la revisión de la medicación antes de la inclusión).
    - Recuento de CD4 <350/mm3 en la selección.
    - Infección oportunista definitoria de SIDA en los 12 meses anteriores al inicio de la selección.
    17) Presencia de disfagia, diarrea crónica, obstrucción intestinal u otros factores que afecten a la ingesta y absorción del fármaco.
    18) Presencia de alergia o intolerancia conocida a fuzuloparib, al acetato de abiraterona, a la prednisona o a sus excipientes.
    19) Infección confirmada por SARS-CoV-2 (COVID-19) (prueba validada positiva), o sospecha de infección por COVID-19 (síntomas clínicos sin resultados documentados) o contacto estrecho con una persona con infección conocida o sospechada por COVID-19, en las 4 semanas anteriores a la primera dosis. Se puede incluir al sujeto con un resultado negativo documentado para una prueba validada de COVID-19.
    20) Presencia de enfermedades concomitantes (como diabetes mellitus grave, trastorno tiroideo y trastornos psiquiátricos) o cualquier otra situación que pueda suponer un riesgo grave para la seguridad de los sujetos o que pueda afectar a su capacidad para completar el estudio según el criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    - Cohort 1: rPFS (assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 and PCWG3 criteria) in unselected mCRPC subjects.
    - Cohort 2: rPFS (assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 and PCWG3 criteria) in mCRPC subjects harboring DRD.
    - Cohorte 1: SSPr (evaluada mediante revisión central independiente enmascarada [RCIE] de acuerdo con los criterios RECIST 1.1 y PCWG3) en sujetos con CPRCm no seleccionados.
    - Cohorte 2: SSPr (evaluada mediante RCIE de acuerdo con los criterios RECIST 1.1 y PCWG3) en sujetos con CPRCm que albergan DRD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At predetermined time points as described in the protocol.
    En momentos predeterminados según se describe en el protocolo.
    E.5.2Secondary end point(s)
    - OS in unselected mCRPC subjects (Cohort 1) and in mCRPC subjects harboring DRD (Cohort 2), respectively.
    - SG en sujetos con CPRCm no seleccionados (cohorte 1) y en sujetos con CPRCm que albergan DRD (cohorte 2), respectivamente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At predetermined time points as described in the protocol.
    En momentos predeterminados según se describe en el protocolo.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Australia
    Belgium
    China
    Czechia
    France
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 482
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 322
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 804
    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)
    NA
    NA
    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 Decision2021-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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