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    Summary
    EudraCT Number:2015-002590-38
    Sponsor's Protocol Code Number:17777
    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:2016-09-26
    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 number2015-002590-38
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled Phase III study of ODM-201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer
    Estudio de fase III aleatorizado, doble ciego, controlado con placebo de ODM-201 comparado con placebo, en combinación con el tratamiento estándar de privación androgénica y docetaxel en pacientes con cáncer de próstata metastásico sensible a hormonas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ODM-201 in addition to standard hormone therapy and docetaxel in metastatic hormone-sensitive prostate cancer
    ODM-201 en combinación con el tratamiento estándar de hormonas y docetaxel en el cáncer de próstata metastásico sensible a hormonas
    A.3.2Name or abbreviated title of the trial where available
    ARASENS
    ARASENS
    A.4.1Sponsor's protocol code number17777
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034900102372
    B.5.6E-mailclinical-trials-contact@bayer.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 nameODM-201 300mg film-coated tablet
    D.3.2Product code BAY 1841788 300mg film-coated tablet
    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 INNBAY 1841788
    D.3.9.1CAS number 1297538-32-9
    D.3.9.2Current sponsor codeODM-201
    D.3.9.3Other descriptive nameBAY 1841788
    D.3.9.4EV Substance CodeSUB71144
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Docetaxel cell phaгm 20 mg/ml concentгate fог solution fог infusion
    D.2.1.1.2Name of the Marketing Authorisation holdercell phaгm 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.3.1Product nameDocetaxel cell phaгm 20 mg/ml concentгate fог solution fог infusion
    D.3.4Pharmaceutical form Concentrate for 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 INNDOCETAXEL
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Metastatic hormone-sensitive prostate cancer (mHSPC)
    Cáncer de próstata metastásico sensible a hormonas (CPMSH)
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which does respond to hormonal treatment
    Cáncer de próstata que no responde al tratamiento hormonal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    • To demonstrate the superiority in overall survival of ODM-201 in addition to standard androgen deprivation therapy (ADT) and docetaxel over placebo in addition to standard ADT and docetaxel
    Demostrar la superioridad en la supervivencia general (SG) de ODM-201 combinado con el TPA estándar y docetaxel sobre placebo combinado con el TPA estándar y docetaxel
    E.2.2Secondary objectives of the trial
    • Time to castration-resistant prostate cancer
    • Time to initiation of subsequent antineoplastic therapy
    • Symptomatic skeletal event free survival (SSE-FS)
    • Time to first symptomatic skeletal event (SSE)
    • Time to initiation of opioid use for ≥7 consecutive days
    • Time to pain progression
    • Time to worsening of physical symptoms of disease based on Functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 (NCCN-FACT FPSI-17)
    • Safety
    - El tiempo hasta el cáncer de próstata resistente a la castración
    - El tiempo hasta el inicio del tratamiento antineoplásico posterior
    - La supervivencia sin acontecimientos óseos sintomáticos (Symptomatic skeletal event free survival, SSE-FS)
    - El tiempo hasta el primer acontecimiento óseo sintomático (Symptomatic skeletal event, SSE)
    - El tiempo hasta el inicio del consumo de opiáceos durante ≥7 días consecutivos
    - El tiempo hasta la progresión del dolor
    - El tiempo hasta el empeoramiento de los síntomas físicos de la enfermedad según la evaluación funcional del tratamiento del cáncer/el cuestionario de 17 ítems del índice de síntomas del cáncer de próstata de la National Comprehensive Cancer Network (NCCN-FACT FPSI-17)
    - Seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria at the time of Screening:
    1. Written informed consent.
    2. Males >= 18 years of age.
    3. Histologically or cytologically confirmed adenocarcinoma of prostate.
    4. Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review. Metastatic disease is defined as either malignant lesions in bone scan or measurable lymph nodes above the aortic bifurcation or soft tissue/visceral lesions according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Lymph nodes are measurable if the short axis diameter is >= 15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is >= 10 mm.
    • Subjects with regional lymph node metastases only (N1, below the aortic bifurcation) will not be eligible for the study. Only subjects with non-regional lymph node metastases (M1a) and/or bone metastases (M1b) and/or other sites of metastases with or without bone disease (M1c) will be eligible.
    5. Subjects must be candidates for ADT and docetaxel therapy per Investigator’s judgment.
    6. Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before randomization. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks prior to randomization is recommended. First generation anti-androgen has to be stopped prior to randomization.
    7. An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
    8. Blood counts at Screening: hemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1.5x109/L, platelet count >= 100x109/L (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at Screening).
    9. Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) <= 1.5 x upper limit of normal (ULN), total bilirubin <= ULN, creatinine <= 2.0 x ULN.
    10. Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with ODM-201/placebo and for 3 months after treatment with ODM-201/placebo and 6 months after treatment with docetaxel.
    1. Consentimiento informado por escrito
    2. Hombres >= 18 años de edad
    3. Adenocarcinoma de próstata confirmado citológicamente o histológicamente
    4. Enfermedad metastásica documentada, ya sea por una gammagrafía ósea positiva o por metástasis de tejidos blandos o viscerales, ya sea por una tomografía axial computarizada (TAC) o una resonancia magnética (RM) de abdomen/pelvis/tórax realzadas con contraste, evaluadas por el investigador y confirmadas mediante revisión central de radiología. La enfermedad metastásica se define como la presencia de lesiones malignas en la gammagrafía ósea o ganglios linfáticos medibles por encima de la bifurcación aórtica o como lesiones de tejidos blandos/viscerales, según los criterios de evaluación de respuesta en tumores sólidos (RECIST) 1.1. Los ganglios linfáticos son medibles si el diámetro del eje corto es >= 15 mm; las lesiones viscerales/de tejidos blandos son medibles si el diámetro del eje largo es >= 10 mm.
    Los pacientes con metástasis de ganglios linfáticos regionales solamente (N1, debajo de la bifurcación aórtica) no serán aptos para el estudio. Solo serán aptos los pacientes con metástasis en los ganglios linfáticos no regionales (M1a) y/o metástasis óseas (M1b) y/o con metástasis en otras localizaciones con o sin enfermedad ósea (M1c).
    5. Los pacientes deben ser tributarios para el TPA y el tratamiento con docetaxel según a juicio del investigador.
    6. Haber iniciado un TPA (agonista/antagonista de LHRH u orquiectomía) con o sin antiandrógeno de primera generación, pero no más de 12 semanas antes de la aleatorización. Para los sujetos que reciben agonistas de LHRH, se recomienda el tratamiento en combinación con un antiandrógeno de primera generación durante al menos 4 semanas antes de la aleatorización. El antiandrógeno de primera generación debe suspenderse antes de la aleatorización.
    7. Estado general de 0 o 1 según la escala del Grupo Oncológico Cooperativo del Este.
    8. Hemogramas en la selección: hemoglobina >= 9,0 g/dl, recuento absoluto de neutrófilos >=1,5x109/l, recuento plaquetario >= 100x109/l (el paciente no debe haber recibido ningún factor de crecimiento en las 4 semanas ni ninguna transfusión de sangre en los 7 días anteriores a la muestra analítica de hematología obtenida en la selección).
    9. Valores en la selección de alanina aminotransferasa y/o aspartato transaminasa en suero <= 1,5 x límite superior de la normalidad (LSN), bilirrubina total <= LSN, creatinina <= 2,0 x LSN.
    10. Los pacientes sexualmente activos deben aceptar el uso de preservativos como método de barrera eficaz y abstenerse de donar esperma, y/o sus parejas femeninas con capacidad reproductiva deberán usar un método anticonceptivo eficaz durante el tratamiento con ODM-201/placebo y durante 3 meses después del final del tratamiento con ODM-201/placebo y 6 meses después del tratamiento con docetaxel.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria at the time of Screening will be excluded:
    1. Prior treatment with:
    • LHRH agonist/antagonists started more than 12 weeks before randomization
    • Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201, other
    investigational AR inhibitors
    • Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
    • Chemotherapy or immunotherapy for prostate cancer prior to randomization
    2. Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.
    3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
    4. Contraindication to both CT and MRI contrast agent.
    5. Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV).
    6. Uncontrolled hypertension as indicated by a resting systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite medical management.
    7. Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free.
    8. A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study drug.
    9. An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment.
    10. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
    11. Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results.
    12. Inability to swallow oral medications.
    13. Close affiliation with the investigational site (e.g., a close relative of the Investigator, dependent person [e.g., employee or student of the investigational site]).
    14. Previous assignment to treatment in this study.
    1. Tratamiento previo con:
    o Agonistas/antagonistas de LHRH iniciados más de 12 semanas antes de la aleatorización.
    o Inhibidores del receptor de andrógenos (RA) de segunda generación, como enzalutamida, ARN-509, ODM-201, u otros inhibidores del RA en investigación.
    o Inhibidor de la enzima del citocromo P17, como acetato de abiraterona o ketoconazol por vía oral como tratamiento antineoplásico para el cáncer de próstata.
    o Quimioterapia o inmunoterapia para el cáncer de próstata antes de la aleatorización.
    2. Tratamiento con radioterapia (radioterapia externa, braquiterapia o radiofármacos) en las 2 semanas previas a la aleatorización.
    3. Hipersensibilidad conocida a cualquiera de los fármacos del estudio, grupos de fármacos del estudio o excipientes en la formulación de los fármacos del estudio.
    4. Contraindicación al medio de contraste para la TAC y la RM.
    5. Haber tenido alguno de los siguientes acontecimientos durante los 6 meses anteriores a la aleatorización: accidente cerebrovascular, infarto de miocardio, angina de pecho grave/inestable, injerto de derivación arterial coronario/periférico, insuficiencia cardíaca congestiva (clase III o IV de la New York Heart Association).
    6. Hipertensión no controlada, indicada por una presión arterial sistólica de >=160 mm Hg o diastólica de >=100 mm Hg en reposo, a pesar del tratamiento médico.
    7. Haber tenido una neoplasia maligna previa. Se permite el carcinoma de células escamosas o basocelular de piel o el cáncer de vejiga superficial, tratado adecuadamente, que no se haya extendido por detrás de la capa de tejido conectivo (es decir, pTis, pTa y pT1), así como cualquier otro tipo de cáncer para el que se haya completado el tratamiento >=5 años antes de la aleatorización y del que el paciente haya estado libre de enfermedad.
    8. Trastorno o procedimiento gastrointestinal que se espera que interfiera significativamente con la absorción del fármaco del estudio.
    9. Hepatitis viral activa, infección conocida por el virus de la inmunodeficiencia humana con carga viral detectable o enfermedad hepática crónica con necesidad de tratamiento.
    10. Participación simultánea o previa (durante los 28 días antes de iniciar el fármaco del estudio o 5 semividas del tratamiento en investigación del estudio previo, lo que sea más prolongado) en otro estudio clínico con medicamentos en investigación
    11. Cualquier otra enfermedad grave o inestable, o situación médica, social o psicológica, que pudiera poner en peligro la seguridad del paciente o el cumplimiento de los procedimientos de estudio, o que pudiera interferir con la participación del paciente en el estudio o la evaluación de los resultados del estudio.
    12. Incapacidad para tragar la medicación oral.
    13. Tener una relación estrecha con el centro de investigación (p. ej., un pariente cercano del investigador, persona dependiente [como un empleado o estudiante del centro de investigación]).
    14. Haber sido asignado anteriormente al tratamiento en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival, defined as the time (in days) from date of randomization until death from any cause.
    Supervivencia general, definida como el tiempo (en días) transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed when approximately 509 deaths occur in the 2 treatment arms combined. The expected study duration for 509 deaths is approximately 70 months.
    El análisis principal se realizará cuando se produzcan aproximadamente 509 muertes en los 2 grupos de tratamiento combinados. La duración del estudio prevista para 509 muertes es de aproximadamente 70 meses.
    E.5.2Secondary end point(s)
    • Time to castration-resistant prostate cancer
    • Time to initiation of subsequent antineoplastic therapy
    • Symptomatic skeletal event free survival (SSE-FS)
    • Time to first symptomatic skeletal event (SSE)
    • Time to initiation of opioid use for ≥7 consecutive days
    • Time to pain progression
    • Time to worsening of physical symptoms of disease based on NCCN-FACT FPSI-17
    • Safety
    - El tiempo hasta el cáncer de próstata resistente a la castración
    - El tiempo hasta el inicio del tratamiento antineoplásico posterior
    - La supervivencia sin acontecimientos óseos sintomáticos (Symptomatic skeletal event free survival, SSE-FS)
    - El tiempo hasta el primer acontecimiento óseo sintomático (Symptomatic skeletal event, SSE)
    - El tiempo hasta el inicio del consumo de opiáceos durante ≥7 días consecutivos
    - El tiempo hasta la progresión del dolor
    - El tiempo hasta el empeoramiento de los síntomas físicos de la enfermedad según la evaluación funcional del tratamiento del cáncer/el cuestionario de 17 ítems del índice de síntomas del cáncer de próstata de la National Comprehensive Cancer Network (NCCN-FACT FPSI-17)
    - Seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL,or the time to progression by soft tissue lesions or time to progression by bone lesions
    •Time from randomization to initiation of first subsequent antineoplastic therapy for prostate cancer
    •Time from randomization to the first occurrence of SSE or death from any cause
    •Time from randomization to the first occurrence of SSE
    •Time from date of randomization to the date of first opiate use for ≥7 consecutive days
    •Interval from randomization to the first date a subject experiences a pain progression
    •Interval from randomization to the first date a subject experiences an increase in physical symptoms based on the NCCN FACT FPSI 17 questionnaire.
    •Refer to protocol section 10.3.3 for safety variables
    • El tiempo de progresión de PSA con la testosterona sérica estando a nivel de castración <0,50 ng / ml, o el tiempo hasta la progresión de las lesiones de tejidos blandos o tiempo hasta la progresión de las lesiones óseas
    • Tiempo desde la aleatorización hasta la iniciación de la primera terapia antineoplásica posterior para el cáncer de próstata
    • Tiempo desde la aleatorización hasta la primera aparición de la ESS o muerte por cualquier causa
    • Tiempo desde la aleatorización hasta la primera aparición de la ESS
    • Tiempo desde la fecha de la aleatorización hasta la fecha del primer uso opiaceo para >= 7 días consecutivos
    • Intervalo desde la aleatorización hasta la primera fecha en la que un sujeto experimenta una progresión del dolor
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Overall survival
    Supervivencia promedio
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    Finland
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Switzerland
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days25
    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: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Verbal statement of consent can be given in the presence of impartial witness (independent of Sponsor and Investigator). To be documented by signature from informing physician and from witness.
    El comunicado verbal del consentimiento puede ser dado en presencia de testigos imparciales (independiente del promotor y del investigador). Tiene que ser documentado mediante la firma del médico y de los testigos.
    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 527
    F.4.2.2In the whole clinical trial 1300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After treatment discontinuation, subjects will enter the Active Followup period and then the Long-term (Survival) Follow-up period. Therapy after discontinuation of treatment is detailed in section 8.2 'post studytherapy' of the protocol.
    Después de la interrupción del tratamiento, los sujetos entrarán en el período de seguimiento activo y luego en el período de seguimiento a Largo-Plazo (Supervivencia). La terapia después de la interrupción del tratamiento se detalla en el apartado 8.2 "post studytherapy 'del protocolo.
    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 Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-04
    P. End of Trial
    P.End of Trial StatusOngoing
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