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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2015-000735-32
    Sponsor's Protocol Code Number:56021927PCR3002
    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:2015-08-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-000735-32
    A.3Full title of the trial
    A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Estudio fase 3 aleatorizado, doble-ciego y controlado con placebo de JNJ-56021927 más terapia de privación de andrógenos (TPA) frente a TPA en sujetos con cáncer de próstata metastásico hormonosensible (CPmHS) de baja
    carga tumoral.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants with Low-Volume mHSPC
    Estudio fase 3 aleatorizado, doble-ciego y controlado con placebo de
    JNJ-56021927 más terapia de privación de andrógenos (TPA) frente a TPA en
    sujetos con cáncer de próstata metastásico hormonosensible (CPmHS) de baja
    carga tumoral.
    A.4.1Sponsor's protocol code number56021927PCR3002
    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.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-Cilag International NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag, S.A.
    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.5.4Telephone number34917228100
    B.5.5Fax number34917228628
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code JNJ-56021927
    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 INNNot assigned
    D.3.9.1CAS number 956104-40-8
    D.3.9.3Other descriptive nameJNJ-56021927-AAA
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboFilm-coated tablet
    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
    Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Cáncer de próstata metastásico hormonosensible (CPmHS) de baja carga tumoral
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    Cáncer de Próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The primary objective is to determine if the addition of JNJ-56021927 to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or OS for subjects with low-volume mHSPC.
    El objetivo principal es determinar si la adición de JNJ-56021927 a la terapia de privación de andrógenos (TPA) es más eficaz para mejorar la supervivencia libre de progresión radiográfica (SLPr) o la supervivencia global (SG) en pacientes con CPmHS de baja carga tumoral.
    E.2.2Secondary objectives of the trial
    *To evaluate clinically relevant improvements with addition of JNJ-56021927 to ADT including delays in pain progression and opioid use for prostate cancer, skeletal-related events, and the need for cytotoxic chemotherapy
    *To characterize the safety of adding JNJ-56021927 to ADT in subjects with low-volume mHSPC
    *To characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-56021927
    *To evaluate the concentration of leuprolide and assess the PD effect of leuprolide on testosterone concentrations when used alone or in combination with JNJ-56021927
    * Evaluar las mejoras clínicamente relevantes con la adición de JNJ-56021927 a la TPA, como los retrasos en la progresión del dolor y el uso de opioides por el cáncer de próstata, los eventos óseos relacionados y la necesidad de quimioterapia citotóxica.
    * Caracterizar la seguridad de la adición de JNJ-56021927 a la TPA en los pacientes con CPmHS de baja carga tumoral
    * Caracterizar la farmacocinética (FC) y la farmacodinamia (FD) poblacionales de JNJ-56021927
    * Determinar la concentración de leuprolida y evaluar el efecto en la FD de leuprolida en las concentraciones de testosterona cuando se usa sola o en combinación con JNJ-56021927
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization, histologic evidence of prostate adenocarcinoma from a metastatic lesion is required
    - Metastatic disease documented by >= 2 bone lesions on 99mTc bone scan
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0, 1, or 2
    - Allowed prior treatment for prostate cancer:
    a) Maximum of 1 course of radiation or surgical intervention;
    b) Up to 6 cycles of docetaxel for low-volume disease with the last dose within 2 months of randomization;
    c) Must not have experienced disease progression between the last dose of docetaxel and Screening;
    d) Participants who did not receive prior docetaxel may have received less than or equal to (<=) 3 months of ADT in the metastatic disease setting prior to randomization. Participants who received prior docetaxel may have received <= 6 months ADT in the metastatic setting prior to randomization;
    e) May also have received up to 6 months of GnRHa in the adjuvant or neo-adjuvant setting as long as it was completed greater than (>)1 year prior to randomization; f) May have received radiation therapy or prostatectomy as definitive therapy
    - Adenocarcinoma de próstata; si se diagnostica mayor o igual que (> =) 5 años desde la aleatorización, se requiere evidencia histológica de adenocarcinoma de próstata a partir de una lesión metastásica
    - Enfermedad metastásica documentada por> = 2 lesiones óseas en la gammagrafía ósea con 99mTc
    - Eastern Cooperative Oncology Group estado funcional (ECOG PS) calificación de 0, 1 ó 2
    - Se permite un tratamiento previo para el cáncer de próstata:
    a) máximo de 1 curso de radiación o intervención quirúrgica;
    b) Hasta 6 ciclos de docetaxel para la enfernedad de baja carga tumoral habiendo recibido la última dosis en los 2 meses antes de la aleatorización ;
    c) No debe haber experimentado progresión de la enfermedad entre la última dosis de docetaxel y el periodo basal;
    d) Los participantes que no recibieron docetaxel antes pueden haber recibido menor o igual que (<=) 3 meses de ADT en la fase metastásica de la enfermedad y antes de la aleatorización. Los participantes que recibieron docetaxel antes pueden haber recibido <= 6 meses de ADT en la fase de la enfermedad metastásica antes de la aleatorización;
    e) también puede haber recibido hasta 6 meses de GnRHa en el tratamiento adyuvante o neoadyuvante, siempre y cuando se completase el tratamiento por (>) 1 año antes de la aleatorización; f) Pueden haber recibido radioterapia o prostatectomía como terapia definitiva
    E.4Principal exclusion criteria
    - Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
    - Known brain metastases
    - Lymph nodes as only site of metastasis
    - Visceral metastasis observed on computed tomography (CT)/magnetic resonance imaging (MRI) or >= 4 bone lesions on 99mTc bone scan with at least 1 lesion beyond the pelvis or vertebral column
    - Any prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
    - Prior treatment with other second generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
    - History of seizures or medications known to lower seizure threshold
    -Hallazgo anatomopatológico compatible con carcinoma de próstata de células pequeñas, ductal o neuroendocrino
    -Metástasis cerebrales conocidas
    -Ganglios linfáticos como única zona de metástasis
    -Metástasis visceral (es decir, hígado o pulmón) observada en el TAC/RM o >= 4 lesiones óseas en la gammagrafía ósea con 99mTc, con al menos 1 lesión más allá de la pelvis o la columna vertebral.
    -Cualquier enfermedad maligna previa dentro de los 5 años anteriores a la aleatorización con la excepción de carcinoma de piel de células escamosas o basales o cáncer de vejiga superficial no invasivo
    -Tratamiento previo con otros anti-andrógenos de segunda generación u otros inhibidores de CYP17, inmunoterapia o agentes de radiofármacos para el cáncer de próstata
    - Historia de las convulsiones o medicamentos que se sabe que baja el umbral convulsivo
    E.5 End points
    E.5.1Primary end point(s)
    - Radiographic Progression-Free Survival (rPFS)
    - Overall Survival (OS)
    - Supervivencia libre de progresión radiográfica (SLPr)
    - Supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Up to 76 Months
    - Up to 76 Months
    -Hasta 76 Meses
    -Hasta 76 Meses
    E.5.2Secondary end point(s)
    - Time to Pain Progression
    - Time to Skeletal-Related Event (SRE)
    - Time to Chronic Opioid Use
    - Time to Initiation of Cytotoxic Chemotherapy
    - Tiempo hasta progresión del dolor
    -Tiempo hasta Evento Óseo Relacionado (EOR)
    -Tiempo hasta uso crónico de opioides
    -Tiempo hasta Inicio de quimioterapia citotóxica
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to 76 Months
    - Up to 76 Months
    - Up to 76 Months
    - Up to 76 Months
    -Hasta 76 Meses
    -Hasta 76 Meses
    -Hasta 76 Meses
    -Hasta 76 Meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers and tumour response assessments
    Biomarcadores y evaluaciones de respuesta tumoral
    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) 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Czech Republic
    Korea, Republic of
    Russian Federation
    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
    EoT Visit is within 30 days after the last dose of study drug for all subjects.
    Visita de fin de estudio es dentro de 30 días después de la última dosis del fármaco de estudio para todos los sujetos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1000
    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)
    In the event of a positive study result at either of the interim analyses or at the final analysis, all subjects in the treatment Phase will have the opportunity to enroll in an Open-label Extension Phase, which will allow subjects to receive active drug (JNJ-56021927) for up to 3 years.
    En caso de resultado positivo del estudio en cualquiera de los análisis intermedios o en el análisis final, todos los sujetos en la fase de tratamiento tendrán la oportunidad de inscribirse en un ensayo abierto de fase de extensión, lo que
    permitirá a los sujetos que reciban el fármaco activo (JNJ -56021927) durante un máximo de 3 años.
    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 Decision2015-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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