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    EudraCT Number:2018-001072-37
    Sponsor's Protocol Code Number:IRFMN-EN-7556
    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:2018-10-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-001072-37
    A.3Full title of the trial
    AtTEnd: Atezolizumab Trial in Endometrial cancer - Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer.
    AtTEnd: Ensayo de Fase III, doble ciego, aleatorizado y controlado con placebo de atezolizumab en combinación con paclitaxel y carboplatino en mujeres con cáncer de endometrio avanzado o recurrente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International study that compares a chemotherapy regimen with atezolizumab, paclitaxel and carboplatin versus a regimen with placebo, paclitaxel and carboplatin in patients affected by advanced or recurrent endometrial cancer
    Estudio internacional que compara un régimen de quimioterapia con atezolizumab, paclitaxel y carboplatino versus un régimen con placebo, paclitaxel y carboplatino en pacientes afectados por cáncer de endometrio avanzado o recurrente
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberIRFMN-EN-7556
    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 SponsorIRCCS - Istituto di Ricerche Farmacologiche Mario Negri
    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 supportF. Hoffmann-La Roche Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto di Ricerche Farmacologiche Mario Negri
    B.5.2Functional name of contact pointElena Biagioli
    B.5.3 Address:
    B.5.3.1Street AddressVia G. La Masa 19
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20156
    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 Yes
    D. name TECENTRIQ
    D. of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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. 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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed, histologically-confirmed stage III-IV endometrial carcinoma/carcinosarcoma with residual disease after
    surgery, either measurable or evaluable, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer
    patients if not yet treated for recurrent disease.
    Carcinoma/carcinosarcoma de endometrio de estadio III-IV recién diagnosticado con confirmación histológica con enfermedad residual tras cirugía, mensurable o evaluable, y sin tratamiento antineoplásico sistémico de primera línea previo. Pacientes con cáncer de endometrio recurrente si todavía no han recibido tratamiento para la enfermedad recurrente
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent endometrial cancer
    Cancer endometrial avanzado o recurrente
    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 10014772
    E.1.2Term Endometrioid adenocarcinoma recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014776
    E.1.2Term Endometrioid adenocarcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014777
    E.1.2Term Endometrioid adenocarcinoma stage IV
    E.1.2System Organ Class 100000004864
    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 the efficacy in terms of PFS and OS
    of first-line atezolizumab versus placebo in combination with carboplatin and paclitaxel in patients with advanced stage III/IV or
    recurrent endometrial cancer.
    Evaluar la eficacia en cuanto a la SSP(Supervivencia Sin Progresión) y SG (Supervivencia Global) del atezolizumab de primera línea frente al placebo en combinación con carboplatino y paclitaxel en pacientes con cáncer de endometrio avanzado en estadio III/IV o recurrente.
    E.2.2Secondary objectives of the trial
    1.To determine the efficacy of
    atezolizumab as measured by:
    •Objective response rate (ORR) as assessed per RECIST v1.1 and median response duration
    •Time from randomization to second progression
    2.To assess the safety and tolerability of the addition of atezolizumab.
    3.To evaluate the effects of the addition of atezolizumab to carbo-taxol chemotherapy on Health-related Quality of Life (HRQoL)
    and patient function (physical, role).
    4.To evaluate any treatment burden patients may experience in association with atezolizumab versus placebo.
    5.To evaluate and compare between treatment arms patients' health status as measured by the EQ-5D-5L (including EQ VAS) to
    generate utility score.
    1. Determinar la eficacia del atezolizumab según la determinación de:
    Tasa de respuesta objetiva (TRO) según los criterios RECIST v 1.1 y la mediana de la duración de la respuesta
    Tiempo desde la aleatorización hasta la segunda progresión
    2. Evaluar la seguridad y la tolerabilidad de la adición de atezolizumab.
    3. Evaluar los efectos de la adición de atezolizumab a la quimioterapia con carbotaxol en la calidad de vida relacionada con la salud (CVRS) y la función del paciente (física, de rol).
    4. Evaluar la carga del tratamiento que puedan sufrir las pacientes en relación con la adición del atezolizumab versus placebo.
    5. Evaluar y comparar la utilidad de salud de las pacientes de los grupos de tratamiento según la medida del EQ-5D-5L para generar puntuaciones de utilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1. Newly diagnosed, histologically-confirmed with residual disease after surgery either measurable or evaluable, or inoperable stage III-IV endometrial carcinoma/carcinosarcoma, after diagnostic biopsy, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer patients if not yet treated for recurrent disease.
    I-2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    I-3. Age ≥ 18 years
    I-4. In recurrent patients, only one prior line of systemic platinum-based regimen is permitted if the platinum-free interval ≥ 6 months. Such prior line is the up-front/adjuvant treatment which can be concurrent chemoradiation or concurrent chemoradiation followed by chemotherapy or only chemotherapy.
    I-5. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to start of study treatment.
    I-6. Previous pelvic and outside pelvis radiation is allowed, except for whole abdominal radiotherapy, if completed more than 6 weeks ago.
    I-7. Signed informed consent and ability to comply with treatment and follow-up.
    I-8. Representative FFPE tumor sample or, only if unfeasible, at least 20 unstained slides from initial surgery or from diagnostic biopsy, in case surgery was not performed, available and sent to central laboratory for Micro Satellite (MS) determination prior to randomization.
    I-9. Patients must have normal organ and bone marrow function :
    a. Haemoglobin ≥ 10.0 g/dL.
    b. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
    c. Platelet count ≥ 100 x 109/L.
    d. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
    e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
    f. Serum creatinine ≤ 1.5 x institutional ULN
    I-1. Carcinoma/carcinosarcoma de endometrio de estadio III-IV recién diagnosticado con confirmación histológica con enfermedad residual tras cirugía, mensurable o evaluable, tras biopsia de diagnóstico, y sin tratamiento antineoplásico sistémico previo o de primera línea. Pacientes con cáncer de endometrio recurrente si todavía no han recibido tratamiento para la enfermedad recurrente.
    I-2. Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0-2
    I-3. Edad ≥18 años
    I-4. Solo se permite una sola línea previa de tratamiento sistémico con platino si el intervalo sin platino fue ≥ 6 meses. Esta línea previa es el tratamiento neoadyuvante/adyuvante que puede ser quimiorradioterapia simultánea, quimiorradioterapia simultánea seguida de quimioterapia o quimioterapia sola.
    I-5. Las pacientes con antecedentes de cáncer de mama primario podrían ser aptas para participar si han completado su tratamiento antineoplásico definitivo hace más de 3 años y siguen libres de cáncer de mama antes del inicio del tratamiento del estudio.
    I-6. Está permitida la radioterapia previa en la pelvis y fuera de la pelvis si se ha completado con más de 6 semanas de anterioridad.
    I-7. Consentimiento informado firmado y capacidad para cumplir con el tratamiento y el seguimiento.
    I-8. Disponibilidad de una muestra tumoral FFPE (Formalin-fixed Paraffin Embedded) representativa o, sólo si no es viable, al menos 20 preparaciones sin tinción de la cirugía inicial o de la biopsia de diagnóstico, si no se realizó cirugía, que se enviará al laboratorio central para la determinación de los microsatélites (MS) antes de la aleatorización.
    I-9. Las pacientes deben tener las funciones orgánicas y de la médula ósea normales:
    a. Hemoglobina ≥ 10,0 g/dl.
    b. Recuento absoluto de neutrófilos (RAN) ≥1,5 x 109/l.
    c. 100 x 109/l.
    d. 1,5 x límite superior de la normalidad (LSN) institucional.
    e. Aspartato aminotransferasa/Transaminasa glutámico-oxalacética sérica (ASAT/SGOT) y alanina aminotransferasa/transaminasa glutamicopirúvica 2,5 x LSN salvo en presencia de metástasis hepáticas, en 5 x LSN.
    f. 1,5 x LSN institucional
    E.4Principal exclusion criteria
    E-1.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ
    cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast. Patients with a history of localized malignancy diagnosed over 5
    years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient
    remains free of recurrent or metastatic disease.
    E-2.Patients with uterine leiomyosarcoma.
    E-3.Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of
    any major surgery.
    E-4.Previous allogeneic bone marrow transplant or previous solid organ transplantation.
    E-5.Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy,
    or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
    E-6.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies
    or anti-CTLA4 .
    E-7.Treatment with systemic immunostimulatory agents.
    E-8. Treatment with systemic corticosteroids or other systemic immunosuppressive medications.
    E-9.History of autoimmune disease
    E-10.Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
    E-11.Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or
    hepatitis C .
    E-12.Active tuberculosis (all patients will have tuberculin [PPD] skin test or Interferon-Gamma Releasing Assay [IGRA] done locally
    prior to inclusion to study)
    E-13.Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    E-14.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated
    vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example
    approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza vaccine.
    E-15.Clinically significant (e.g. active) cardiovascular disease, including:
    a.Myocardial infarction or unstable angina within ≤ 6 months of randomization,
    b.New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
    c.Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
    d.Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or
    E-16.Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT
    E-17.History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks
    prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in
    any case of suspected central nervous system (CNS) involvement .
    E-18.History or evidence upon neurological examination of central nervous system (CNS) disease, unless asymptomatic and
    adequately treated with standard medical therapy.
    E-19.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable
    suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for
    treatment related complications.
    E-20. Women of childbearing potential (<2 years after last menstruation) not willing to use highly-effective means of
    E-21.Pregnant or lactating women.
    E-22.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion
    E-23.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the
    atezolizumab formulation.
    E-24.Known hypersensitivity reaction or allergy to drugs chemically related to carboplatin, paclitaxel, or their excipients that
    contraindicates the subject’s participation.
    E-1. Otras malignidades en los últimos 5 años, salvo: cáncer de piel no melanoma tratado adecuadamente, cáncer cervical localizado tratado curativamente, carcinoma ductal localizado (CDL) de la mama. Las pacientes con antecedentes de neoplasia maligna localizada diagnosticada hace más de 5 años pueden ser aptas para participar siempre que hayan completado su tratamiento sistémico adyuvante antes de la aleatorización y que la paciente siga libre de enfermedad recurrente o metastásica.
    E-2. Pacientes con leiomiosarcoma uterino.
    E-3. Cirugía mayor en las 4 semanas previas al inicio del tratamiento del estudio o pacientes que no se hayan recuperado por completo de los efectos de una cirugía mayor.
    E-4. Antecedentes de trasplante de médula ósea alogénica o trasplante de órgano sólido.
    E-5. Administración simultánea de otros fármacos quimioterapéuticos, cualquier otro tratamiento antineoplásico u hormonoterapia antineoplásica, o radioterapia simultánea durante el periodo de tratamiento del ensayo (se permite el tratamiento de reposición hormonal).
    E-6. Tratamiento previo con agonistas de CD137 o terapias de bloqueo del punto de control inmunitario, anticuerpos terapéuticos anti-PD1 o anti-PDL1 o anti-CLTA4.
    E-7. Tratamiento con agentes inmunoestimuladores sistémicos.
    E-8. Tratamiento con corticosteroides sistémicos u otros medicamentos inmunodepresores sistémicos.
    E-9. Antecedentes de enfermedad autoinmunitaria.
    E-10.Pacientes inmunocomprometidos, p. ej., pacientes que se sabe que son seropositivos para el virus de la inmunodeficiencia humana (VIH).
    E-11.Pacientes con hepatitis B activa (definida como un resultado positivo en la prueba del antígeno de superficie de la hepatitis B [HBsAg] en la selección) o hepatitis C.
    E-12.Tuberculosis activa (todas las pacientes se someterán a la prueba cutánea de la tuberculina [PPD] o al ensayo de liberación de interferón gamma [IGRA] realizada localmente antes de la inclusión en el estudio)
    E-13.Signos o síntomas de infección en las 2 semanas previas al día 1 del ciclo 1.
    E-14.Administración de una vacuna viva atenuada en las 4 semanas previas al día 1 del ciclo 1 o previsión de que durante el estudio se deba administrar una vacuna viva atenuada. La vacuna de la gripe debe administrarse únicamente durante la temporada de gripe (por ejemplo, aproximadamente de octubre a marzo en el hemisferio norte). Las pacientes no deben recibir una vacuna viva atenuada de la gripe.
    E-15.Enfermedad cardiovascular clínicamente significativa (p. ej. activa), que incluye:
    a. Infarto de miocardio o angina inestable en ≤ 6 meses de la aleatorización,
    b. Insuficiencia cardíaca congestiva (ICC) de grado ≥ 2 según la New York Heart Association (NYHA),
    c. Arritmia cardíaca mal controlada pese a la medicación (las pacientes con fibrilación auricular con frecuencia controlada son aptas para participar),
    d. Enfermedad vascular periférica de grado ≥ 3 (p. ej., sintomática e interfiere con las actividades cotidianas, que requiere reparación o revisión)
    E-16.ECG en reposo con QTc > 470 ms en 2 o más puntos temporales en un periodo de 24 horas o antecedentes familiares de QT prolongado.
    E-17.Antecedentes o sospecha clínica de metástasis cerebrales o compresión de la médula espinal. Es obligatorio realizar una TC/RM (en las 4 semanas previas a la aleatorización) si se sospecha de metástasis cerebrales. La RM vertebral es obligatoria (en las 4 semanas previas a la aleatorización) en cualquier caso en el que se sospeche una implicación del sistema nervioso central (SNC).
    E-18.Antecedentes o evidencia en la exploración neurológica de enfermedad del sistema nervioso central (SNC), salvo que sea asintomática y esté tratada adecuadamente con el tratamiento médico habitual.
    E-19.Evidencia de cualquier otra enfermedad, disfunción metabólica, hallazgo de exploración física o resultado analítico que haga sospechar, razonablemente, de la presencia de una enfermedad o afección que contraindique el uso del fármaco en investigación o ponga a la paciente en un riesgo elevado de sufrir complicaciones relacionadas con el tratamiento.
    E-20. Las mujeres en edad fértil (< 2 años después de la última menstruación) que no estén dispuestas a utilizar métodos anticonceptivos de alta eficacia.
    E-21.Mujeres embarazadas o en periodo de lactancia.
    E-22.Antecedentes de reacciones alérgicas, anafilácticas u otras reacciones de hipersensibilidad graves a anticuerpos quiméricos o humanizados o proteínas de fusión.
    E-23.Hipersensibilidad o alergias conocidas a productos biofarmacéuticos producidos con células de ovario de hámster chino o a cualquier componente de la formulación de atezolizumab.
    E-24.Reacción de hipersensibilidad o alergias conocidas a los fármacos relacionados químicamente con el carboplatino, el paclitaxel o sus excipientes que contraindique la participación del sujeto.
    E.5 End points
    E.5.1Primary end point(s)
    The study has two coprimary endpoints: OS
    and PFS.
    PFS is defined as the time from randomization to the date of first progression or death from any cause, whichever comes first.
    Progression will be established as the radiological disease progression according to RECIST 1.1 or death from any cause, whichever
    occurs first.
    OS is defined as the time from randomization until the date of death from any cause.
    El estudio tiene dos criterios de valoración principales: SG y la SSP .

    SSP se define como el tiempo desde la aleatorización hasta la fecha de la primera progresión o muerte por cualquier causa, lo que ocurra primero.
    La progresión se establecerá como la progresión de la enfermedad radiológica según RECIST 1.1 o la muerte por cualquier causa, cualquiera que ocurrese primero.
    SG se define como el tiempo desde la aleatorización hasta la fecha de la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments should be performed every 9 weeks during the chemotherapy treatment then every 12 weeks
    during the maintenance treatment (atezolizumab or placebo) for the first year from randomization. After the first year the
    assessment during the maintenance phase should be performed every 6 months until progression. Survival data will be collected
    up to the time of the final analysis.
    Las evaluaciones de tumores deben realizarse cada 9 semanas durante el tratamiento de quimioterapia y luego cada 12 semanas
    durante el tratamiento de mantenimiento (atezolizumab o placebo) durante el primer año desde la aleatorización. Después del primer año la evaluación durante la fase de mantenimiento debe realizarse cada 6 meses hasta la progresión. Se recopilarán datos de supervivencia.
    Hasta el momento del análisis final.
    E.5.2Secondary end point(s)
    Objective Response Rate (ORR), defined
    as the percentage of patients with an objective response as determined by RECIST 1.1
    La respuesta objetiva (ORR) se define como RC o RP según la determinación del investigador mediante el uso de RECIST v 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessments should be performed every 9 weeks during the chemotherapy treatment then every 12 weeks
    during the maintenance treatment (atezolizumab or placebo) for the first year from randomization. After the first year the
    assessment during the maintenance phase should be performed every 6 months until progression.
    Las evaluaciones de tumores deben realizarse cada 9 semanas durante el tratamiento de quimioterapia y luego cada 12 semanas
    durante el tratamiento de mantenimiento (atezolizumab o placebo) durante el primer año desde la aleatorización. Después del primer año el la evaluación durante la fase de mantenimiento debe realizarse cada 6 meses hasta la progresión.
    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 No
    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. 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    United Kingdom
    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
    UVUP. Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 470
    F.4.2.2In the whole clinical trial 550
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SAKK
    G.4.3.4Network Country Switzerland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation A-AGO Austria
    G.4.3.4Network Country Austria
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation AGO Germany
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation PGOG
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation GEICO - Spain
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation NCRI - UK
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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