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    Summary
    EudraCT Number:2015-000134-30
    Sponsor's Protocol Code Number:I5B-MC-JGDJ
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-10
    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 number2015-000134-30
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma
    Ensayo de fase 3, aleatorizado, doble ciego, controlado con placebo, en el
    que se compara doxorubicina y olaratumab con doxorubicina y placebo, en
    pacientes con sarcoma de tejidos blandos en estadio avanzado o
    metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Soft Tissue Sarcoma
    Un estudio de Doxorubicina y Olaratumab frente a Doxorubicina y Placebo
    en pacientes con sarcoma de tejidos blandos
    A.4.1Sponsor's protocol code numberI5B-MC-JGDJ
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02451943
    A.5.4Other Identifiers
    Name:Trial NameNumber:ANNOUNCE
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointMaria Pilar López
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916231218
    B.5.5Fax number0034916633481
    B.5.6E-maillopez_maria_pilar@lilly.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1447
    D.3 Description of the IMP
    D.3.1Product nameOlaratumab
    D.3.2Product code LY3012207
    D.3.4Pharmaceutical form 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 INNOlaratumab
    D.3.9.1CAS number 1024603-93-7
    D.3.9.2Current sponsor codeLY3012207
    D.3.9.3Other descriptive nameOLARATUMAB
    D.3.9.4EV Substance CodeSUB67904
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameDoxorubicin
    D.3.4Pharmaceutical form 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 INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameDexrazoxane
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNDEXRAZOXANE
    D.3.9.1CAS number 24584-09-6
    D.3.9.4EV Substance CodeSUB07046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboSolution 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
    Advanced or Metastatic Soft Tissue Sarcoma
    Sarcoma de tejidos blandos en estadio avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    cancer of the connective tissue that has worsened or grown in other parts of the body
    cáncer del tejido conectivo que haya empeorado o crecido en otras partes del cuerpo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10041298
    E.1.2Term Soft tissue sarcomas histology unspecified
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare doxorubicin plus olaratumab versus doxorubicin plus placebo with respect to OS in 2 populations:
    1) Patients with advanced or metastatic soft tissue sarcoma (STS) not amenable to treatment with surgery or radiotherapy with curative intent.
    2) Patients with advanced or metastatic leiomyosarcoma (LMS) not amenable to treatment with surfery or radiotherapy with curative intent.
    El objetivo principal es comparar doxorubicina y olaratumab con doxorubicina y placebo, en relación con la supervivencia global (SG) en 2 pobalciones:
    1) En pacientes con sarcoma de tejidos blandos (STB) metastásico o en estadio avanzado que no puedan someterse a una intervención quirúrgica ni recibir radioterapia con fines curativos.
    2) Pacientes con leiomiosarcoma (LMS) metastásico o en estadio avanzado que no puedan someterse a una intervención quirúrgica ni recibir radioterapia con fines curativos.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare doxorubicin plus olaratumab
    versus doxorubicin plus placebo with respect to: ? Progression-free survival (PFS) ?
    Objective response rate (ORR) (complete response [CR] + partial response [PR]) ?
    Disease control rate (DCR; CR + PR + stable disease [SD]) ? Duration of response
    (DoR) ? Duration of disease control ? Patient-reported outcomes (PROs): Pain,
    Health-related Quality of Life (HRQoL), and health status ? Safety and tolerability ?
    Pharmacokinetics (PK) and immunogenicity
    Los objetivos secundarios del estudio consisten en comparar doxorubicina y olaratumab con doxorubicina y placebo, en relación con los siguientes puntos:
    ?Supervivencia sin progresión (SSP)
    ?Tasa de respuestas objetivas (TRO) (respuestas completas [RC] + respuestas parciales [RP])
    ?Tasa de control de la enfermedad (TCE; RC + RP + enfermedad estable [EE])
    ?Duración de la respuesta (DdR)
    ?Duración del control de la enfermedad
    ?Resultados percibidos por los pacientes (RPP): Dolor, calidad de vida relacionada con la salud (CdVRS) y estado de salud
    ?Seguridad y tolerabilidad
    ?Farmacocinética (FC) e inmunogenicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 years or older at study entry
    - Histologically confirmed diagnosis of locally advanced unresectable or metastatic STS not amenable to curative treatment with surgery or radiotherapy. Grade 1 liposarcoma are elegible if there is histological or radiographic evidence of evolution to more aggresive disease. (excludes GIST & Kaposi)
    - Measurable or nonmeasurable but evaluable disease by RECIST 1.1
    - ECOG 0-1
    - May have had any number of prior systemic therapies for advanced/metastatic disease, however may not have received any previous treatment with anthracyclines. All previous therapies must
    have been completed ? 4 weeks (28 days) prior to randomization.
    - Consent to provide adequate archived FFPE tumor tissue or be subject to a pre-treatment biopsy of primary or metastatic tumor tissue for research
    LVEF ?= 50%
    - Life expectancy, in opinion of the investigator, is at least 3 months
    - Females of child-bearing potential must have a negative serum
    pregnancy test within 7 days prior to randomization.
    - 18 años o mayor en el momento de su inlcusión en el estudio
    - Diagnóstico, confirmado histológicamente, de enfermedad STB metastásica o localmente avanzada e irresecable, y no puede someterse a una intervención quirúrgica ni recibir radioterapia con fines curativos (excluido TEGI & Kaposi)
    - Liposarcoma grado 1 elegible si hay evidencia histológica o radiográfica de la evolución a una enfermedad mas agresiva.
    - Enfermedad mensurable o no, pero evaluable por RECIST 1.1
    - ECOG 0-1
    - Puede haber recibido cualquier número de tratamientos citotóxicos sistémicos previos para tratar la enfermedad avanzada/metastásica, pero no haber recibido anteriormente ningún tratamiento con antraciclinas. Todos los tratamientos previos deben de haber finalizado ? 4 semanas (28 días) antes de la aleatorización.
    - Ha otorgado su consentimiento para que se recoja una muestra aceptable de tejido tumoral conservado en FFIP o para que se le realice antes del tratamiento una biopsia del tejido tumoral primario o metastásico
    - FEVI >= 50%
    - Tiene una esperanza de vida de al menos 3 meses
    - Las mujeres en edad fértil deben tener una prueba de embarazo en suero negativa dentro de los 7 días anteriores a la aleatorización.
    E.4Principal exclusion criteria
    - Diagnosed with GIST or Kaposi sarcoma
    - Active CNS or brain metastasis at randomization
    - The patient has received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones; the
    patient has received prior olaratumab treatment.
    - Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation
    - Electively planned or required major surgery during the study
    - Uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics, symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF), severe myocardial insufficiency, cardiac arrhythmia, cardiomyopathy, or a psychiatric illness/social situation that would limit compliance with study requirements
    - Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
    - Resting heart rate of >= 100 bpm
    - QTc interval >= 450 msec and >= 470 msec for males and females, respectively, on screening ECG
    - Current hematologic malignancies
    - Pregnant or breastfeeding
    - Active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)
    - Se ha diagnosticado un tumor del estroma gastrointestinal (TEGI) o sarcoma de Kaposi
    - Presenta metástasis activa en el SNC o metástasis cerebral en el momento de aleatorización
    - El paciente ha recibido tratamiento previo con doxorubicina, epirrubicina, idarrubicina u otras antraciclinas y antracenodionas; el paciente ha recibido tratamiento previo con olaratumab.
    - Ha recibido radioterapia previa o irradiación de pelvis total
    - Tiene programada o requerirá una intervención de cirugía mayor durante el estudio
    - Presenta una enfermedad intercurrente sin controlar, entre otras, a título orientativo que no limitativo, una infección persistente/activa que requiera la administración de antibióticos por vía parenteral, insuficiencia cardiaca congestiva (ICC) sintomática, disfunción ventricular izquierdo (FEVI < 50 %), insuficiencia miocárdica grave, arritmia cardiaca, miocardiopatía o enfermedad psiquiátrica / situación social que limitaría el cumplimiento de los requisitos del estudio
    - Ha experimentado angina de pecho inestable o infarto de miocardio, o se le ha realizado una angioplastia o la implantación de una endoprótesis cardiaca
    - Presenta en reposo una frecuencia cardiaca > 100 lpm
    - Intervalo QTc > 450 ms (varones) o > 470 ms (mujeres) en el ECG que se realice durante el proceso de selección
    - Tiene en la actualidad neoplasias malignas hematológicas
    - Embarazada o en periodo de lactancia
    - Tiene una infección fúngica, bacteriana y/o vírica, incluidos el virus de la inmunodeficiencia humana (HIV) o hepatitis vírica (A, B o C) (no se requiere realizar pruebas de detección)
    E.5 End points
    E.5.1Primary end point(s)
    Overall suvival
    Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    time from randomization to death
    Período de tiempo transcurrido desde la aleatorización al fallecimiento del paciente
    E.5.2Secondary end point(s)
    ? PFS
    ? ORR
    ? DCR
    - Time to first worsening of the mBPI-sf (Brief Pain Inventory Short Form Modified) "worst pain" score
    ? Duration of response
    ? Duration of disease control
    ? Safety and tolerability
    ? PK and immunogenicity
    ? SSP
    ? TRO
    ? TCE
    - el tiempo transcurrido hasta la fecha en la que se observe por primera vez un empeoramiento de la puntuación del ?dolor más intenso? del cuestionario mBPI-sf
    ? Duración de la respuesta
    ? Duración del control de la enfermedad
    ? Resultados percibidos por los pacientes (RPP): dolor, la calidad de vida relacionada con la salud (HRQoL) y estado de salud
    ? Seguridad y tolerabilidad
    ? FC e Inmunogenicidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PFS is determined from the date of randomization and the date on which disease progresses or the date on which the patient dies, from any cause, whichever is earlier.
    - Response rates (ORR=CR+PR/Randomized subjects) (DCR=CR+PR+SD/Randomized siubejcts) will be based on evaluations done every 6 weeks until radiographic documentation of progression.
    - DoR and duration of disease control is measured from the time measurement criteria are first met for CR or PR until the first date of objective progression is observed .
    - PRO: Day 1 of every cycle, Short-Term Follow-Up and Long-Term Follow-Up
    - Safety and tolerability: On study treatment, Short-Term Follow-Up and
    Long-Term Follow-Up
    - PK and immunogenicity: At various time points according to the protocol and in the event of IRR
    -SSP desde fecha aleatorización y fecha en que progresa enfermedad o fecha en que paciente fallece, por cualquier causa, lo que ocurra antes
    -Tasa respuesta (TRO=RC+RP/pac aleatorizados)(TCE=RC+RP+EE/pac aleatorizados) basada en evaluaciones hechas cada 6 semanas hasta que se documente radiológicamente progresión enfermedad
    -RPP: Día 1 de cada ciclo, Visita Seguimiento Corto Plazo y Visita Seguimiento Largo Plazo
    -DdR y duración control enfermedad se mide desde momento que cumplan por primera vez criterios RC o RP hasta el día que documente por primera vez recurrencia enfermedad o progresión objetiva
    -Seguridad y tolerabilidad:mientras estén recibiendo tratamiento y en Visita Seguimiento Corto Plazo
    -FC e Inmunogenicidad:En distintos momentos según protocolo y en caso que ocurra RRI
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Denmark
    Finland
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Democratic People's 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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 460
    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)
    Following PD, patients will be contacted every 2 months to obtain survival information and subsequent anticancer treatment (if applicable) for the first 2 years, then every 6 months until the patient?s death or overall study completion.
    Una vez que el paciente presente progresión de la enfermedad se contactará con él cada 2 meses durante los 2 primeros años para obtener información relativa a la supervivencia y a los posteriores tratamientos antineoplásicos (si corresponde); posteriormente, cada 6 meses hasta el fallecimiento del paciente o la finalización global del estudio
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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