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    Summary
    EudraCT Number:2015-004472-30
    Sponsor's Protocol Code Number:MITO-23
    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:2017-12-21
    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 number2015-004472-30
    A.3Full title of the trial
    Randomized phase III trial on Trabectedin (ET-743) vs clinician's choice
    chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube
    cancers of BRCA mutated or BRCAness phenotype patients
    MITO-23
    Estudio en fase III aleatorizado sobre trabectedina (ET 743) frente a la
    quimioterapia elegida por el clínico en pacientes con cáncer ovárico,
    peritoneal primario o tubárico con fenotipo de mutación en BRCA o
    BRCAness – MITO-23
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    fallopian tube cancers of BRCA mutated or BRCAness phenotype treated
    with Trabectedin compared to a standard treatment.
    calcular la supervivencia global de pacientes con recidiva de tumor ovárico,
    de las Trompas de Falopio o primitivo de peritoneo con mutaciones del
    BRCA o con fenotipo BRCAness, tratados con Trabectedina, respecto a un
    tratamiento estándar.
    A.4.1Sponsor's protocol code numberMITO-23
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02903004
    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 SponsorFondazione IRCCS Istituto Nazionale dei Tumori
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharma Mar
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Giacomo Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number3902239038183063
    B.5.5Fax number390223903991
    B.5.6E-mailtrialcenter@istitutotumori.mi.it
    B.Sponsor: 2
    B.1.1Name of SponsorGrupo Español de Investigacion en Cancer de Ovario GEICO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharma Mar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIbertrials
    B.5.2Functional name of contact pointAmelia Alcazar
    B.5.3 Address:
    B.5.3.1Street AddressC/ Camino Fuente de la Mora, 9, 1º
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number3491629813121
    B.5.5Fax number34914474211
    B.5.6E-mailamelia.alcazar@ibertrials.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 Yes
    D.2.1.1.1Trade name Yondelis 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameYondelis 1 mg
    D.3.2Product code ET-743
    D.3.4Pharmaceutical form Powder and solvent for 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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeCT 7917
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient with recurrence of ovarian tumor, fallopian tube or peritoneum
    primitive that has a BRCA mutation or BRCAness phenotype.
    Paciente con recidiva de tumor ovárico, de trompa de Falopio o primitivo
    de peritoneo que presenta una mutación del BRCA o del fenotipo
    BRCAness.
    E.1.1.1Medical condition in easily understood language
    Patients with ovarian, primary or tubal peritoneal cancer with mutation
    phenotype in BRCA or BRCAness
    Pacientes con cáncer ovárico, peritoneal primario o tubárico con fenotipo
    de mutación en BRCA o BRCAness
    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 10033271
    E.1.2Term Ovarian neoplasia
    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 10016183
    E.1.2Term Fallopian tube cancer NOS
    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 10026340
    E.1.2Term Malignant neoplasm of peritoneum, unspecified
    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
    The main objective is to compare overall survival (OS) between
    treatment groups
    El objetivo principal es comparar la supervivencia global (SG) entre los
    grupos de tratamiento
    E.2.2Secondary objectives of the trial
    Secondary:
    The secondary objectives are to compare the treatment groups in terms
    of:
    • Progression free survival (PFS). In case of CA-125 progression
    according to GCIG criteria is documented, a confirmatory CT scan and a
    radiological CT progression will be required.
    • Radiological response rate (in patients with measurable disease)
    • Duration of response
    • CA-125 response rate per GCIG and change in CA-125
    • Toxicity profile
    • Quality of Life assessments using QLQ-C30 and QLQ-OV28
    Secundarios:
    Los objetivos secundarios son comparar los siguientes parámetros entre
    los grupos de tratamiento:
    • La supervivencia sin progresión (SSP). Si se documenta progresión
    del CA-125 de acuerdo con los criterios del GCIG, se requerirá la confirmación la progresión mediante TC y el estudio radiológico de la progresión.
    • Tasa de respuesta radiológica (en pacientes con enfermedad
    mensurable)
    • Duración de la respuesta
    • Tasa de respuesta de CA-125 según el GCIG y cambio del CA-125
    • Perfil de toxicidad
    • Evaluaciones de la calidad de vida mediante QLQ-C30 y QLQ-OV28
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational Study.- The translational end points are aimed at
    evaluating the impact of altered gene and microRNA (miRNA) expression
    on trabectedin efficacy. This analysis will allow considering which genes
    are involved in the so called BRCAness phenotype (Rigakos G, Razis E.
    BRCAness: finding the Achilles heel in ovarian cancer.Oncologist.
    2012;17:956-62) thought to be more sensitive to this treatment, and
    how these genes are regulated.
    Storage will be centralized at Fondazione IRCCS Istituto Nazionale
    Tumori
    Estudio traslacional.- Los criterios traslacionales de valoración están
    dirigidos a la evaluación del impacto de la alteración de la expresión de
    los genes y del microRNA (miRNA) sobre la eficacia de la trabectedina.
    Este análisis permitirá considerar cuáles son los genes implicados en el
    denominado fenotipo BRCAness (Rigakos G, Razis E. BRCAness: finding
    the Achilles heel in ovarian cancer. Oncologist. 2012;17:956-62), el cual
    se cree que es más sensible a este tratamiento, y el modo en que se
    regulan estos genes.
    La conservación se centralizará en Fondazione IRCCS Istituto Nazionale
    Tumori
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Female of age 18 years or older
    2. Histologically or cytologically documented invasive epithelial ovarian
    cancer, primary peritoneal carcinoma, or fallopian tube cancer
    3. Platinum resistant or sensitive patients with either:
    a. BRCA mutated patients
    b. BRCAness phenotype patients: patients who have received and
    responded (subsequent PFI>6 months) to at least 2 previous platinum
    based chemotherapy lines
    c. Platinum sensitive patients who are not able to receive or not willing
    to receive other platinum treatments
    4. Measurable and evaluable disease per RECIST 1.1(Subjects with
    isolated rising CA-125 without radiologically visible disease are
    excluded)
    5. ECOG performance status 0 or 1
    6. No limits in the number of previous chemotherapy lines, previous
    treatment with parp inhibitors is allowed
    7. Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit
    normal
    8. Life expectancy of at least 3 months
    9. Adequate organ functions:
    a. Hematopoietic: Absolute neutrophil count ≥ 1,500/mm3;
    Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dl
    b. Hepatic: AST and ALT ≤ 1.5 times upper limit of normal
    (ULN)* ; Alkaline Phosphatase ≤ 2.5 times ULN* ; Bilirubin ≤ 1.5 times
    ULN. NOTE: * ≤ 3 times ULN if liver metastases are present
    c. Renal: Creatinine Clearance ≥ 45 ml/min or Serum Creatinine ≤1.5 x
    ULN
    d. Serum Albumin >2.5 g/dl
    10. No other invasive malignancy within the past 3 years except nonmelanoma
    skin cancer or in situ cervical cancer (patients with previous
    cancers may be enrolled providing that no recurrences have be reported
    in the last 3 years)
    11. Written Informed Consent
    12. Adequately recovered from the acute toxicity of any prior treatment
    13. For agents in the standard arm, also refer to the local prescribing
    information
    1. Mujeres de edad igual o superior a 18 años
    2. Cáncer epitelial ovárico, carcinoma peritoneal primario o cáncer
    tubárico, invasivos y demostrados histológica o citológicamente cáncer
    3. Pacientes resistentes o sensibles a platino con cualquiera de los
    siguientes:
    a. Mutación de BRCA
    b. Fenotipo BRCAness: pacientes que han recibido y respondido
    (ulterior PFI > 6 meses) como mínimo a 2 líneas previas de
    quimioterapia con platino
    c. Pacientes sensibles a platino que no pueden o no quieren recibir
    otros tratamientos con platino
    4. Enfermedad mensurable y evaluable según los RECIST 1.1 (se
    excluye a pacientes con elevación aislada de CA-125 sin enfermedad
    radiológicamente visible)
    5. Estado funcional ECOG 0 o 1
    6. Número ilimitado de líneas previas de quimioterapia; se permite el
    tratamiento previo con inhibidores de la parp
    7. Fracción de eyección ventricular izquierda (FEVI) ≥ límite inferior
    normal del centro
    8. Esperanza de vida al menos de 3 meses.
    9. Funciones orgánicas adecuadas:
    a. Hematopoyética: Recuento absoluto de neutrófilos
    ≥ 1500/mm3.; Recuento plaquetario ≥ 100000/mm3; hemoglobina ≥ 9
    g/dl
    b. Hepática: AST y ALT ≤ 1,5 x límite superior normal (LSN)*; fosfatasa
    alcalina ≤ 2,5 x LSN*; bilirrubina ≤ 1,5 x LSN. NOTA: * ≤ 3 x el LSN si
    hay metástasis hepáticas
    c. Renal: Aclaramiento de creatinina ≥ 45 ml/min o creatinina sérica ≤
    1,5 x LSN
    d. Albúmina sérica > 2,5 g/dl
    10. Ninguna otra neoplasia maligna invasiva durante los 3 años
    precedentes, excepto cáncer cutáneo no melanomatoso o cáncer cervical
    in situ (puede incluirse a pacientes con cánceres previos siempre que no
    se haya diagnosticado una recidiva en los 3 años precedentes)
    11. Consentimiento informado por escrito
    12. Recuperación adecuada de la toxicidad aguda de cualquier
    tratamiento previo
    13. En cuanto a los agentes del grupo estándar, consúltense también
    las advertencias, precauciones y contraindicaciones de las fichas
    técnicas locales
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Prior exposure to trabectedin
    2. Known hypersensitivity to any of the components of the trabectedin
    i.v. formulation or dexamethasone
    3. Subjects with borderline ovarian cancer, ie. Subject with low
    malignant potential tumors are excluded
    4. At least 2 reported responses to platinum (i.e. subsequent recurrences
    at least 6 months after the first and the second platinum based
    treatment), unless BRCA mutation is documented.
    5. Less than 4 weeks from last dose of therapy with any investigational
    agent, or chemotherapy
    6. History of another neoplastic disease (except basal cell carcinoma or
    cervical carcinoma in situ adequately treated) unless in remission for 3
    years or longer
    7. Known clinically relevant CNS metastases, unless treated and
    asymptomatic
    8. Other serious illnesses, such as:
    a. Congestive heart failure or angina pectoris; myocardial infarction
    within 1 year before enrolment; uncontrolled arterial hypertension or
    arrhythmias.
    b. Psychiatric disorder that prevents compliance with protocol.
    c. Active viral hepatitis; or chronic liver disease.
    d. Active infection.
    e. Any other unstable medical conditions.
    Criterios de exclusión
    1. Exposición previa a trabectedina
    2. Hipersensibilidad conocida a cualquiera de los componentes de la
    formulación IV de trabectedina o a dexametasona
    3. Pacientes con cáncer ovárico de baja malignidad (borderline), es
    decir, se excluirá a las pacientes con tumores de bajo potencial maligno
    4. Menos de 2 respuestas documentadas a platino (es decir, recidivas
    subsiguientes al menos 6 meses después del primer y del segundo
    tratamiento con platino), a menos que se documente una mutación de
    BRCA.
    5. Menos de 4 semanas desde la última dosis de tratamiento con
    cualquier agente experimental o quimioterapia
    6. Antecedentes de otra neoplasia (excepto carcinoma de células
    basales o carcinoma cervical in situ adecuadamente tratado) a menos
    que se mantenga la remisión durante 3 años o más
    7. Metástasis conocidas y clínicamente relevantes en el SNC, a menos
    que se hayan tratado y no condicionen síntomas
    8. Otras enfermedades graves como:
    a. Insuficiencia cardíaca congestiva o angina pectoris; infarto de
    miocardio en el año previo a la inclusión; hipertensión arterial no
    controlada o arritmias.
    b. Trastorno psiquiátrico que impida el cumplimiento del protocolo.
    c. Hepatitis viral activa o hepatopatía crónica.
    d. Infección activa.
    e. Cualquier otra enfermedad médica inestable.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Efficacy will be evaluated based on OS and PFS.
    • OS will be measured from the date of randomization to death due to
    any cause
    • PFS will be measured from the date of randomization to the date of
    first observed disease progression (relapse) or the date of death due to any cause (if before progression).
    Safety
    Descriptive summary tables will be presented on all safety parameters
    by treatment group. Patients will be monitored for adverse events using
    the NCI-CTCAE version 4.0. Treatment-emergent adverse events and
    safety laboratory parameters will be summarized by treatment group
    and NCI-CTCAE v4.0 grade.
    Quality of life will be evaluated QLQ-C30 and QLQ-OV28 questionnaire.
    Eficacia
    La eficacia se evaluará de acuerdo con la SG y la SSP.
    • La SG se determinará desde la fecha de la aleatorización hasta la
    muerte por cualquier causa
    • La SSP se determinará desde la fecha de la aleatorización hasta la
    fecha de la primera progresión observada de la enfermedad (recaída) o
    la fecha de muerte por cualquier causa (si se produce antes de la
    progresión).
    Seguridad
    Se presentarán resúmenes tabulados descriptivos de todos los
    parámetros de seguridad por grupo de tratamiento. Se vigilará la
    aparición de acontecimientos adversos mediante los NCI-CTCAE versión
    4.0. Se resumirán los acontecimientos adversos inducidos por el
    tratamiento y los parámetros analíticos de seguridad por grupo de
    tratamiento y grado de los NCI- CTCAE, v4.0.
    La calidad de vida se evaluará mediante los cuestionarios QLQ-C30 y
    QLQ-OV28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary objetive is to compare the treatment groups in terms of
    overall survival (OS)
    El objetivo principal es comparar los grupos de tratamiento en términos
    de supervivencia general (OS)
    E.5.2Secondary end point(s)
    Progression free survival (PFS) in case of CA125 progression according
    to GCIG criteria is documented, a confirmatory CT scan and a radiological
    CT progression will be required.
    Se documenta la supervivencia libre de progresión (PFS) en el caso de la
    progresión de CA125 según los criterios de GCIG, se requerirá una TC
    confirmatoria y una progresión radiológica de la TC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS will be measured from the date of randomization to the date of first
    observed disease progression (relapse) or the date of death due to any
    cause (if before progression)
    La PFS se medirá desde la fecha de asignación al azar hasta la fecha de
    la primera progresión de la enfermedad observada (recaída) o la fecha
    de muerte por cualquier causa (si antes del progreso)
    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 Yes
    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.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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabina 100
    Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabine 100
    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 concerned29
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 246
    F.4.2.2In the whole clinical trial 246
    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 standard of care in practice and the investigator site.
    El estándar en la practica clínica habitual del centro 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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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