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    Summary
    EudraCT Number:2016-003716-12
    Sponsor's Protocol Code Number:C34004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-02
    Trial results View 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 number2016-003716-12
    A.3Full title of the trial
    Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy
    Estudio en fase II de TAK-659 en pacientes con linfoma difuso de células B grandes recidivante o resistente después de dos o más líneas previas de quimioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    TAK-659 en pacientes con linfoma difuso de células B grandes recidivante o resistente
    A.3.2Name or abbreviated title of the trial where available
    TAK-659 en pacientes con linfoma difuso de células B grandes recidivante o resistente
    A.4.1Sponsor's protocol code numberC34004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03123393
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1187-6208
    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 SponsorMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
    B.1.3.4CountryUnited States
    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 supportMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
    B.5.2Functional name of contact pointStudy Registration Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1866835-2233
    B.5.6E-mailGlobalOncologyMedinfo@takeda.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.3.2Product code TAK-659
    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 INNTAK-659
    D.3.9.2Current sponsor codeTAK-659
    D.3.9.3Other descriptive nameTAK-659
    D.3.9.4EV Substance CodeSUB179395
    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.3.2Product code TAK-659
    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 INNTAK-659
    D.3.9.2Current sponsor codeTAK-659
    D.3.9.3Other descriptive nameTAK-659
    D.3.9.4EV Substance CodeSUB179395
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Linfoma difuso de células B grandes recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Linfoma difuso de células B grandes recidivante o resistente
    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 HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in patients with diffuse large B-cell lymphoma (DLBCL).
    Evaluar la eficacia de TAK-659 a partir de la tasa de respuesta global (TRG), según el comité de revisión independiente radiológico (CRI), en pacientes con linfoma difuso de células B grandes recidivante o resistente (LDCBG).
    E.2.2Secondary objectives of the trial
    • To assess complete response (CR) rate per IRC in patients with DLBCL
    • To assess durable response rate (DRR) per Independent Radiologic Review Committee (IRC) (complete response/partial response (CR/PR) with duration ≥16 weeks, which is the equivalent of 4 cycles for 28-day cycles) in patients with DLBCL.
    • To assess duration of response (DOR) and duration of CR per IRC in patients with DLBCL.
    • To assess overall response rate (ORR) per IRC in the subgroup of patients with germinal center B-cell (GCB) DLBCL.
    • To assess ORR per IRC in the subgroup of patients with DLBCL transformed from indolent lymphoma.
    • To assess progression-free survival (PFS) per IRC in patients with DLBCL.
    • To assess overall survival (OS) in patients with DLBCL.
    • Evaluar la tasa de respuesta completa (RC) según el CRI en pacientes con LDCBG
    • Evaluar la TRD (RC/respuesta parcial [RP] con una duración ≥ 16 semanas, que es equivalente a cuatro ciclos de 28 días) según el CRI en pacientes con LDCBG
    • Evaluar la duración de respuesta (DR) y la duración de la RC según el CRI en pacientes con LDCBG
    • Evaluar la tasa de respuesta global (TRG) según el CRI en el subgrupo de pacientes con LDCBG con células B de centro germinal (GCB)
    • Evaluar la TRG según el CRI en el subgrupo de pacientes con LDCBG transformado a partir de un linfoma no Hodgkin (LNH) indolente
    • Evaluar la supervivencia libre de progresión (SLP) según el CRI en pacientes con LDCBG
    • Evaluar la supervivencia global (SG) según el CRI en pacientes con LDCBG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 years or older.
    2. Patients must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations (double-hit
    DLBCL under DLBCL, NOS, based on the 2008 WHO classification criteria) is not eligible for this study.
    a. Local pathology review for histological confirmation:
    - A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
    3. Relapsed or refractory to ≥2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
    4. For patients who have relapsed or progressed after achieving a response, documented, investigator-assessed relapse or progression after the last treatment is required.
    5. Must have FDG-PET–avid measurable disease that meets the size criteria per IWG as assessed on cross-sectional imaging by CT/MRI.
    6. ECOG performance status score of 0 or 1.
    7. Life expectancy of >3 months
    8. Patients must have adequate organ function, including the following:
    a. Bone marrow reserve: absolute neutrophil count (ANC) ≥1000/μL, platelet count ≥75,000/μL (≥50,000/μL for patients with bone marrow involvement), and hemoglobin ≥8 g/dL (red blood cell [RBC] and
    platelet transfusion allowed ≥14 days before assessment).
    b. Hepatic: total bilirubin ≤1.5 times the upper limit of the normal range (ULN); ALT and AST ≤2.5xULN.
    c. Renal: creatinine clearance ≥60 mL/min either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
    d. Others:
    •Lipase ≤1.5xULN and amylase ≤1.5xULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
    •Blood pressure ≤Grade 1 (hypertensive patients are permitted if their blood pressure is controlled to ≤Grade 1 by hypertensive medications and glycosylated hemoglobin is ≤6.5%).
    1. Varones o mujeres con 18 años o mayors.
    2. Los pacientes deben presentar LDCBG confirmado histológicamente, incluida la enfermedad de novo o la enfermedad transformada a partir de un LNH indolente.El linfoma de células B de alto grado con translocaciones de MYC y BCL-2 y/o BCL-6 (LDCBG doble hit en LDCBG sin especificar, según los criterios de clasificación de la OMS de 2008) no será apto para este estudio

    a. Revisión de la patología local para confirmación histológica:
    - Se requiere un bloque de tumor fijado en formalina y contenido en parafina o portaobjetos de una biopsia fresca con una tinción adecuada.
    3. Recidivante o resistente a ≥ 2 líneas previas de quimioterapia conforme al tratamiento estándar con cierto requisites para la terapia previa.
    4. Para pacientes que hayan presentado recidiva o progresión tras presentar respuesta (definida como RC o RP), se requerirá recidiva o progresión tras el último tratamiento, evaluada por el investigador y documentada.
    5. Deben presentar enfermedad ávida de FDG-PET que cumpla los criterios de tamaño según el GIT mediante evaluación con imágenes transversales por TAC/RM
    E.4Principal exclusion criteria
    1. CNS lymphoma; active brain or leptomeningeal metastases.
    2. Known human immunodeficiency virus (HIV)–related malignancy.
    3. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment.
    4. Radiotherapy less than 3 weeks before the first dose of study treatment.
    5. Known HIV positive (testing not required).
    6. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
    7. Prior ASCT within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
    8. Participants with certain cardiovascular conditions are excluded.
    9. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
    10. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
    11. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
    12. Patients with another malignancy within 2 years of study start. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are
    considered disease-free at the time of study entry.
    13. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
    14. Certain wash-out restrictions before the first dose of study drug on inhibitors of P-gp and/or strong reversible inhibitors of CYP3A, strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or Pgp inducers, grapefruit containing food or beverages.
    1. Linfoma del sistema nervioso central; metástasis activas en el cerebro o leptomeníngeas.
    2. Neoplasia maligna conocida asociada al virus de la inmunodeficiencia humana.
    3. Tratamiento anticanceroso sistémico (incluidos productos en investigación) en las tres semanas anteriores a la primera dosis de tratamiento del studio.
    4. Radioterapia en las tres semanas anteriores a la primera dosis del tratamiento del estudio.
    5. Positivo conocido para VIH (prueba no necesaria).
    6. Positivo conocido para antígeno de superficie de la hepatitis B o infección conocida o sospechada por hepatitis C activa.
    7. TACM en los seis meses anteriores o TACM previo en cualquier momento sin recuperación hematopoyética completa antes del día 1 del ciclo 1, o trasplante alogénico de células madre en cualquier momento.
    8. Participantes con determinadas enfermedades cardiovasculares.
    9. Cirugía mayor en los 14 días anteriores a la primera dosis del fármaco del estudio o recuperación incompleta de cualquier complicación derivada de una intervención quirúrgica.
    10. Infección sistémica que precise tratamiento antibiótico por vía parenteral u otra infección grave (bacteriana, fúngica o vírica) en los 21 días anteriores a la primera dosis del fármaco del estudio.
    11. Tratamiento anticanceroso con dosis altas de corticosteroides en los 7 días anteriores a la primera dosis de TAK-659.
    12. Pacientes que padeciesen otra neoplasia maligna en los 2 años anteriores al inicio del estudio. No se excluirá a los pacientes que padeciesen cáncer de piel no melanómico o carcinoma localizado de cualquier tipo solo si se han sometido a una extirpación completa y se considera que están curados en el momento de incorporarse al estudio.
    13. Enfermedad gastrointestinal (GI) conocida o procedimiento GI que pudiese interferir en la absorción oral o en la tolerancia de TAK-659.
    14. Ciertas restricciones en cuanto al uso o consumo de ciertas sustancias antes de la primera dosis del fármaco del estudio: inhibidores de la gp-P y/o potentes inhibidores reversibles del CYP3A, potentes inhibidores del mecanismo del CYP3A o potentes inductores del CYP3A y/o de la gp-P, así como alimentos o bebidas que contengan pomelo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ORR as assessed by IRC according to the modified 2007 International Working Group (IWG) criteria for malignant lymphoma
    La variable principal es la TSG evaluada por el CRI conforme a los criterios modificados del Grupo Internacional de Trabajo (GIT) de 2007 para el linfoma maligno
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis - after all patients enrolled in the study have had the opportunity to complete 6 cycles of treatment with study drug.
    Conclusion of the study - when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    Análisis primario- Después de que todos los pacientes reclutados en el studio hayan tenido la oportunidad de completer 6 ciclos de tratamiento con el medicamento en investigación.
    Fin del ensayo - Cuando los eventos de SG hayan ocurrido en 70% de los pacientes, o 24 meses despúes de la inclusion del ultimo paciente, lo que ocurra primero.
    E.5.2Secondary end point(s)
    • CR rate as assessed by IRC according to the modified 2007 IWG criteria
    • ORR per IRC according to the 2014 IWG (Lugano) criteria.
    • CR rate per IRC according to the 2014 IWG (Lugano) criteria.
    • DRR (rate of CR/PR with duration ≥16 weeks, which is equivalent to 4 cycles for 28-day cycles) per IRC.
    • DOR and duration of CR per IRC.
    • ORR per IRC in patients with GCB DLBCL.
    • ORR per IRC in patients with DLBCL transformed from indolent NHL.
    • PFS per IRC.
    • OS.
    • TSG evaluada por el CRI conforme a los criterios del GIT de 2014 (Lugano)[2].
    • RC evaluada por el CRI conforme a los criterios del GIT de 2014 (Lugano)[2].
    • TRD (tasa de RC/RP con una duración ≥ 16 semanas, que es equivalente a cuatro ciclos para ciclos de 28 días) evaluada por el CRI.
    • DRG y duración de la RC según el CRI.
    • TRG Según el CRI en pacientes con LDCBG GCB.
    • TRG Según el CRI en pacientes con LDCBG transformado a partir de un LNH indolente.
    • SSP según el CRI.
    • SG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary analysis - after all patients enrolled in the study have had the opportunity to complete 6 cycles of treatment with study drug.
    Conclusion of the study - when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    Análisis primario- Después de que todos los pacientes reclutados en el studio hayan tenido la oportunidad de completer 6 ciclos de tratamiento con el medicamento en investigación.
    Fin del ensayo - Cuando los eventos de SG hayan ocurrido en 70% de los pacientes, o 24 meses despúes de la inclusion del ultimo paciente, lo que ocurra primero.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    France
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Conclusion of the study will be considered when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    El fin del ensayo sera considerado cuando los eventos de SG hayan ocurrido en 70% de los pacientes, o 24 meses después de la inclusion del ultimo paciente, lo que ocurra primero.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    F.2 Gender
    F.2.1Female Yes
    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 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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 82
    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)
    The patient will receive the normal treatment of that condition, at investigator's discretion
    El paciente recibirá el tratamiento normal de esa condición, a discreción del investigador
    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 Decision2017-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-17
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