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    Summary
    EudraCT Number:2017-003552-23
    Sponsor's Protocol Code Number:64091742PCR2002
    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:2018-01-04
    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 number2017-003552-23
    A.3Full title of the trial
    A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
    Estudio fase 1b-2 de Niraparib en combinación con terapias para el tratamiento del cáncer de próstata metastásico resistente a castración
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the tolerability, safety and anti-tumor effect of Niraparib in combination with JNJ-63723283 in men with metastatic castration-resistant prostate cancer (mCRPC)
    Estudio para entender la tolerabilidad, seguridad y el efecto antitumoral de Niraparib, en combinación con otro fármaco (JNJ-63723283) en hombres con cáncer de próstata metastásico resistente a castración.
    A.3.2Name or abbreviated title of the trial where available
    64091742PCR2002
    64091742PCR2002
    A.4.1Sponsor's protocol code number64091742PCR2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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 nameNiraparib 100 mg capsules
    D.3.2Product code JNJ-64091742
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameniraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    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 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 nameJNJ-63723283
    D.3.2Product code JNJ-63723283
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Assigned
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Metastatic castration-resistant prostate cancer (mCRPC)
    Cáncer de próstata resistente a la castración metastásico (CPRCm)
    E.1.1.1Medical condition in easily understood language
    Metastatic castration-resistant prostate cancer (mCRPC)
    Cáncer de próstata resistente a la castración metastásico (CPRCm)
    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 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 10036909
    E.1.2Term Prostate cancer metastatic
    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 evaluate the tolerability of niraparib combination therapies for the treatment of mCRPC
    - Determine the recommended Phase 2 dose (RP2D) of niraparib combination therapies

    Part 2 (Dose Expansion):
    - To evaluate the antitumor effect of the RP2D of niraparib combination therapies for treatment of mCRPC
    - To evaluate the safety of the RP2D of niraparib combination therapies for the treatment of mCRPC
    Parte 1:
    - Evaluar la tolerabilidad de combinaciones con niraparib en el tratamiento de CPRCm
    - Determinar la dosis recomendada para la fase 2 (DRF2) de combinaciones con niraparib
    Parte 2 ( ampliación de la dosis)
    - Evaluar el efecto antitumoral de la DRF2 combinaciones con niraparib en el tratamiento del CPRCm
    - Evaluar la seguridad de la DRF2 de combinaciones con niraparib en el tratamiento del CPRCm
    E.2.2Secondary objectives of the trial
    Part 1:
    - To characterize the pharmacokinetics (PK) and immunogenicity (if applicable) of niraparib combination therapies
    Part 2:
    - To evaluate other response outcomes of niraparib combination therapies for the treatment of mCRPC
    - To evaluate duration of response
    - To characterize the PK and immunogenicity (if applicable) of niraparib combination therapies through sparse sampling
    Parte 1:
    - Definir la farmacocinética y la inmunogenicidad (si procede) de combinaciones con niraparib
    Parte 2:
    - Evaluar otras variables de respuesta de combinaciones con niraparib en el tratamiento del CPRCm
    - Evaluar la duración de la respuesta
    - Definir la farmacocinética y la inmunogenicidad (si procede) de combinaciones con niraparib mediante obtención de muestras esporádicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects of age 18 years or older
    2. Willing to undergo all protocol-specified biopsies
    3. Diagnosis of prostate adenocarcinoma as confirmed by the investigator.
    4. Must have determination of biomarker status (either biomarker-positive [BM+] or biomarker–negative [BM-] by the sponsor’s blood-based assay
    5. Subjects must have measurable disease as defined by RECIST 1.1 (soft tissue lesion of ≥10mm in the long axis or extrapelvic lymph node of ≥15mm in the short axis).
    6. Must have previously received at least 1, but no more than 2, lines of novel AR-targeted therapy (eg, abiraterone acetate with prednisone, enzalutamide, apalutamide) for prostate cancer. Subjects must have had at least 4 weeks of AR-targeted therapy
    7. Must have castrate levels of testosterone ≤50 ng/dL on a gonadotropin releasing hormone analogue (GnRHa), or history of bilateral orchiectomy at study entry
    8. Progression of metastatic prostate cancer at study entry defined as having one or more of the following:
    a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination (per Prostate Cancer Working Group 3 [PCWG3] criteria). The PSA level at the screening visit should be ≥2 μg/L (2 ng/mL).
    b. Radiographic progression by bone scan per PCWG3 or by soft tissue per RECIST 1.1.
    9. Must be willing to continue GnRHa during the study if not surgically castrate.
    10. Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
    11. Subjects who received prior therapy with an anti-androgen (eg, bicalutamide, flutamide, nilutamide, abiraterone acetate with prednisone, enzalutamide, apalutamide) must have at least a 4-week washout prior to enrollment.
    12. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drugs and for 5 months following the last dose of study drugs to:
    a.Use a condom during sexual activity.
    b.Not donate sperm.
    13. Clinical laboratory values at Screening:
    a.Absolute neutrophil count (ANC) ≥1.5 x 10^9/L, independent of growth factors for 30 days
    b.Hemoglobin ≥9.0 g/dL, independent of growth factors or transfusions for 30 days
    c.Platelet count ≥100 x 10^9/L, independent of growth factors or transfusions for 30 days
    d.Serum albumin ≥3.0 g/dL
    e.Creatinine clearance ≥30 mL/min/1.73 m^2 either calculated or directly measured via 24-hour urine collection
    f.Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or direct bilirubin ≤1 x ULN (Note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤1.5 x ULN, subject may be eligible as determined by the medical monitor)
    g.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3 x ULN
    h.Fasting glucose ≤250 mg/dL
    1. Edad mínima de 18 años
    2. Disposición a someterse a todas las biopsias especificadas en el protocolo
    3. Diagnóstico de adenocarcinoma de próstata confirmado por el investigador
    4. Determinación del estado relativo a biomarcadores (BM+ o BM-) mediante el análisis en sangre del promotor
    5. Presencia de enfermedad medible conforme a los criterios RECIST 1.1 (lesión de partes blandas ≥ 10 mm en el eje mayor o ganglio linfático extrapélvico ≥ 15 mm en el eje menor)
    6. Recepción previa de al menos una línea, pero no más de dos, de tratamiento dirigido nuevo contra los receptores de andrógenos (por ejemplo, acetato de abiraterona con prednisona, enzalutamida o apalutamida) para el cáncer de próstata. Los sujetos deberán haber recibido tratamiento dirigido contra los receptores de andrógenos durante un mínimo de cuatro semanas
    7. Presencia de una concentración de testosterona de castración ≤ 50 ng/dl con un análogo de la gonadoliberina (GnRH) o antecedentes de orquiectomía bilateral en el momento de incorporación al estudio
    8. Progresión del cáncer de próstata metastásico en el momento de incorporación al estudio, definida como la presencia de una o más de las circunstancias siguientes:
    a. Progresión del PSA, definida por un mínimo de dos concentraciones crecientes de PSA obtenidas con un intervalo ≥ 1 semana entre cada determinación (conforme a los criterios del Grupo de trabajo sobre el cáncer de próstata 3 [PCWG3]). La concentración de PSA en la visita de selección debe ser ≥ 2 µg/l (2 ng/ml)
    b. Progresión radiológica según la gammagrafía ósea conforme a los criterios del PCWG3 o en partes blandas conforme a los criterios RECIST 1.1
    9. Disposición a continuar con el análogo de la GnRH durante el estudio si no se ha realizado una castración quirúrgica.
    10. Puntuación de estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1 (véase el Anexo 2).
    11. Los sujetos que hayan recibido tratamiento previo con un antiandrógeno (por ejemplo, bicalutamida, flutamida, nilutamida, acetato de abiraterona con prednisona, enzalutamida o apalutamida) deberán someterse a un período de lavado de cuatro semanas, como mínimo, antes de su inclusión.
    12. A fin de evitar el riesgo de exposición al fármaco a través del eyaculado (incluso de varones con vasectomía), los sujetos deberán comprometerse durante el tratamiento con los fármacos del estudio y hasta cinco meses después de recibir la última dosis de ellos a:
    a. Utilizar preservativo durante las relaciones sexuales.
    b. No donar semen.
    13. Valores analíticos durante la selección:
    a. Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 10^9/l, independiente de la administración de factores de crecimiento durante 30 días.
    b. Hemoglobina ≥ 9,0 g/dl, independiente de la administración de factores de crecimiento o transfusiones durante 30 días.
    c. Recuento de plaquetas ≥ 100 x 10^9/l, independiente de la administración de factores de crecimiento o transfusiones durante 30 días.
    d. Albúmina sérica ≥ 3,0 g/dl.
    e. Aclaramiento de creatinina ≥ 30 ml/min/1,73 m^2 calculado o medido directamente mediante una recogida de orina de 24 horas.
    f. Bilirrubina total en suero ≤ 1,5 veces el límite superior de la normalidad (LSN) o bilirrubina directa ≤ 1 vez el LSN. (Nota: En los sujetos con síndrome de Gilbert, si la bilirrubina total es > 1,5 veces el LSN, habrá que medir la bilirrubina directa e indirecta y, si la bilirrubina directa es ≤ 1,5 veces el LSN, el sujeto podrá participar en el estudio si así lo determina el monitor médico).
    g. Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ≤ 3 veces el LSN.
    h. Glucemia en ayunas ≤ 250 mg/dl.
    E.4Principal exclusion criteria
    1. Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor.
    2. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
    3. Active malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently remission) ≤2 years prior to enrollment.
    4. Active infection requiring systemic therapy.
    5. Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients (refer to the Investigator’s Brochures).
    6. Human immunodeficiency virus (HIV)-positive subjects with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy.
    b. A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor on exclusion criterion 11.c, a change is made to avoid a potential drug-drug interaction with the study drug).
    c. Receiving antiretroviral therapy that may interfere with the study drug
    (consult the sponsor for review of medication prior to enrollment).
    d. CD4 count <350 cells/mm^3 at screening.
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
    7. Active hepatitis B virus (eg, hepatitis B surface antigen reactive) or active hepatitis C virus (HCV) (eg, HCV ribonucleic acid [RNA] [qualitative] is detected).
    8. If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention prior to starting therapy.
    9. Prior radium treatment or treatment with other therapeutic radiopharmaceuticals for prostate cancer.
    10. Any of the following ≤30 days prior to planned Cycle 1 Day 1:
    a.A transfusion (platelets or red blood cells).
    b.Hematopoietic growth factors.
    c.An investigational agent for prostate cancer.
    d.Major surgery (sponsor's medical monitor should be consulted regarding what constitutes major surgery).
    e.Radiation therapy
    11. Symptomatic brain metastasis from prostate cancer.
    12. Symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, or uncontrolled hypertension.
    13. Any condition for which, in the opinion of the investigator or medical monitor, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    For excl.criteria to combination 1: Niraparib and JNJ63723283:
    1. Prior treatment with sipuleucel-T.
    2. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (including any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    3. Subjects with a history of allergy to protein-based therapies or any significant drug allergy (ie, analphylaxis, heptatotoxicity, or immune-mediated thrombocytopenia or anemia).
    4. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis.
    5. Allergies, hypersensitivity, or intolerance to JNJ-63723283 or the corresponding excipients (refer to the Investigator’s Brochure).
    6. Immunodeficiency or receiving systemic corticosteroid therapy or immunosuppressive therapy (eg, cyclosporine) within 7 days prior to treatment allocation. The use of physiologic doses of corticosteroids may be approved after consultation with the
    sponsor.
    7. Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic
    treatment.
    8. Received a live vaccine within 30 days of the first dose of study drugs.
    1. Tratamiento previo con un inhibidor de la PARP
    2. Antecedentes o diagnóstico presente de SMD/LMA
    3. Neoplasia maligna previa (excepciones: cáncer basocelular o espinocelular de piel correctamente tratado, cáncer de vejiga superficial o cualquier otro cáncer in situ que se encuentre actualmente en remisión completa) en los dos años previos a la inclusión
    4. Infección activa con necesidad de tratamiento sistémico
    5. Alergia, hipersensibilidad o intolerancia conocida a niraparib o sus excipientes (véase el manual del investigador)
    6. Infección por el virus de la inmunodeficiencia humana (VIH) con una o más de las circunstancias siguientes:
    a. El sujeto no está recibiendo tratamiento antirretroviral de gran actividad.
    b. Modificación del tratamiento antirretroviral en los seis meses previos al inicio de la selección (excepto si, tras consultar al promotor en relación con el criterio de exclusión 11.c, la modificación se ha hecho para evitar una interacción farmacológica con el fármaco del estudio).
    c. El sujeto está recibiendo tratamiento antirretroviral que podría interferir con el fármaco del estudio (ha de consultarse al promotor para que revise la medicación antes de la inclusión).
    d. Recuento de linfocitos CD4 < 350 células/mm^3 en la fase de selección.
    e. Infección oportunista definitoria de síndrome de inmunodeficiencia adquirida en los seis meses previos al inicio de la selección.
    7. Infección activa por el virus de la hepatitis B (por ejemplo, reactividad del antígeno de superficie del virus de la hepatitis B) o C (VHC) (por ejemplo, detección de ácido ribonucleico [ARN] del VHC [cualitativo]).
    8. Si un sujeto se ha sometido a una intervención de cirugía mayor, deberá haberse recuperado debidamente de la toxicidad o las complicaciones de la intervención antes de iniciar el tratamiento.
    9. Tratamiento previo con radio o con otros radiofármacos terapéuticos para el cáncer de próstata.
    10. Cualquiera de las circunstancias siguientes en los 30 días previos al día 1 del ciclo 1 previsto:
    a. Transfusión (de plaquetas o eritrocitos).
    b. Administración de factores de crecimiento hematopoyético.
    c. Administración de un fármaco en investigación para el cáncer de próstata.
    d. Intervención de cirugía mayor (ha de consultarse al monitor médico del promotor respecto a lo que constituye una intervención de cirugía mayor).
    e. Radioterapia.
    11. Metástasis cerebrales sintomáticas del cáncer de próstata.
    12. Insuficiencia cardíaca congestiva sintomática (cardiopatía en clase III o IV de la New York Heart Association), angina de pecho inestable, arritmia cardíaca o hipertensión arterial no controlada.
    13. Cualquier trastorno por el que, en opinión del investigador o el monitor médico, la participación en el estudio no sea lo mejor para el sujeto (por ejemplo, afectaría a su bienestar) o pueda impedir, limitar o constituir un factor de confusión en las evaluaciones especificadas en el protocolo

    Criterios de exclusión para la combinación 1: Niraparib y _JNJ63723283:
    1. Tratamiento previo con sipuleucel-T
    2. Tratamiento previo con un anticuerpo anti-CTLA4, anti-PD-1, anti-PD-L1 o anti-PD-L2 (incluido cualquier anticuerpo o fármaco dirigido específicamente contra vías de coestimulación de los linfocitos T o de puntos de control inmunológico)
    3. Sujetos con antecedentes de alergia a tratamientos de base proteínica o de cualquier alergia medicamentosa importante (es decir, anafilaxia, hepatotoxicidad o trombocitopenia o anemia de origen inmunitario)
    4. Antecedentes de neumonitis (no infecciosa) que precisó la administración de corticoides o presencia de una neumonitis activa
    5. Alergia, hipersensibilidad o intolerancia a JNJ JNJ63723283 o sus excipientes (véase el manual del investigador)14,15
    6. Inmunodeficiencia o tratamiento con corticoides sistémicos o inmunodepresores (por ejemplo, ciclosporina) en los siete días previos a la asignación del tratamiento. El uso de dosis fisiológicas de corticoides podrá aprobarse previa consulta al promotor
    7. Enfermedad autoinmunitaria activa que ha precisado tratamiento sistémico en los dos últimos años (es decir, con fármacos modificadores de la enfermedad, corticoides o inmunodepresores). El tratamiento de reposición (por ejemplo, tiroxina, insulina o corticoides fisiológicos por insuficiencia suprarrenal o hipofisaria) no se considera una forma de tratamiento sistémico
    8. Recepción de una vacuna de microorganismos vivos en los 30 días previos a la administración de la primera dosis de los fármacos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    1. Incidence of specified toxicities
    Part 2:
    2. Objective response rate (ORR) of soft tissue (visceral or nodal disease)
    3. Incidence and severity of Adverse events (AEs)
    Parte 1:
    1. Incidencia de los efectos tóxicos específicos
    Parte 2:
    2. Tasa de respuestas objetivas (TOR) de las partes blandas (enfermedad visceral o ganglionar)
    3. Incidencia e intensidad de AA
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. First 28 days of treatment (Cycle 1)
    2. From Cycle (C) 1 Day (D) 1, imaging will be performed every 8 weeks for the first 6 months and then every 12 weeks thereafter
    3. Day 0 to until the End-of-treatment (EOT) visit
    1. Primeros 28 días de tratamiento (Ciclo 1)
    2. Desde Ciclo (C) 1 Día (D) 1, las imágenes serán llevadas a cabo cada 8 semanas para los primeros 6 meses y cada 12 semanas después
    3. Día 0 hasta visita fin de tratamiento
    E.5.2Secondary end point(s)
    Part 1:
    1. Plasma concentrations of niraparib and, if performed, its major metabolite (M1), and plasma or serum concentrations of the combination agent
    2. Population PK parameters and derived exposure of niraparib and combination agent
    3. Anti-drug antibodies (if applicable)
    Part 2:
    4. Circulating tumor cell (CTC) response
    5. Response rate (RR)
    6. Duration of objective response
    7. Overall survival (OS)
    8. Plasma concentrations of niraparib and, if performed, its major metabolite (M1) when dosed with combination agent
    9. Population PK parameters and derived exposure of niraparib and combination agent
    10. Anti-drug antibodies (if applicable)
    Parte 1:
    1. Concentraciones plasmáticas de niraparib y, si se obtienen, de su metabolito principal (M1) cuando se administra en combinación con otro fármaco
    2. Parámetros de farmacocinética poblacional y exposición derivada de niraparib y del fármaco combinado
    3. Anticuerpos contra fármacos (si procede)

    Parte 2:
    4. Respuesta de células tumorales circulantes (CTC)
    5. Tasa de respuesta (TR)
    6. Duración de la respuesta objetiva
    7. Supervivencia global (SG)
    8. Concentraciones plasmáticas de niraparib y, si se obtienen, de su metabolito principal (M1) cuando se administra en combinación con otro fármaco
    9. Parámetros de farmacocinética poblacional y exposición derivada de niraparib y del fármaco combinado
    10. Anticuerpos contra fármacos (si procede)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 8 and 9. Cycle (C) 1 Day (D) 1, C2 D1, C3 D1, C6 D1 and C12 D1
    3 and 10. Cycle 1 (D1, 15), C2 (D1, 15), C3 (D1, 15), C4 (D1, 15), C5 (D1, 15), C6 (D1, 15), C7 (D1, 15), C9 D1, C10 D1, C12 (D1, 15), at end of treatment (EoT) visit and follow-up
    4. At every cycle from C 1 D 1 through C 12 D 1, and at the EoT visit
    5, 6 and 7. Day 1 to until death
    1, 2, 8 and 9. Ciclo (C) 1 Día (D) 1, C2 D1, C3 D1, C6 D1 y C12 D1
    3 and 10. Ciclo 1 (D1, 15), C2 (D1, 15), C3 (D1, 15), C4 (D1, 15), C5 (D1, 15), C6 (D1, 15), C7 (D1, 15), C9 D1, C10 D1, C12 (D1, 15), visita de fin de tratamiento y de seguimiento
    4. Cada ciclo desde C 1 D 1 hasta C 12 D 1, y en l a visita de fin de tratamiento
    5, 6 and 7. Día 1 hasta la muerte.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker Analyses
    Análisis de inmunogenicidad y biomarcadores
    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
    Therapeutic exploratory (Phase II)
    Terapéutico exploratorio (Fase II)
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    Israel
    Spain
    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
    Last subject last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 60
    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)
    Subjects would be managed per their local Standard of Care or go onto other research studies.
    Los pacientes se tratarán según su estándar local de atención y cuidados o irían a otros estudios de investigación.
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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