Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001888-36
    Sponsor's Protocol Code Number:MedOPP098
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-17
    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 number2016-001888-36
    A.3Full title of the trial
    A phase II clinical trial of radium-223 activity in patients with metastatic castration-resistant prostate cancer (mCRPC) with asymptomatic progression while on abiraterone acetate or enzalutamide besides AR-V7 mutational status
    Ensayo clínico de fase II de la actividad de radio 223 en pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) con progresión asintomática durante el tratamiento con acetato de abiraterona o enzalutamida y en función del estado mutacional del gen AR­V7.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II clinical trial of radium-223 activity in patients with metastatic castration-resistant prostate cancer (mCRPC) with asymptomatic progression while on abiraterone acetate or enzalutamide besides AR-V7 mutational status
    Ensayo clínico de fase II de la actividad de radio 223 en pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) con progresión asintomática durante el tratamiento con acetato de abiraterona o enzalutamida y en función del estado mutacional del gen AR­V7.
    A.3.2Name or abbreviated title of the trial where available
    EXCAAPE
    EXCAAPE
    A.4.1Sponsor's protocol code numberMedOPP098
    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 SponsorMedica Scientia Innovation Research (MedSIR ARO)
    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 supportBayer Hispanica SL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedica Scientia Innovation Research (MedSIR ARO)
    B.5.2Functional name of contact pointSilvia Monzonís
    B.5.3 Address:
    B.5.3.1Street AddressRambla de Cataluña, 2-4D;
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code0807
    B.5.3.4CountrySpain
    B.5.4Telephone number003493221 41 35
    B.5.5Fax number0034932992382
    B.5.6E-mailsilvia.monzonis@medsir.org
    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 XOFIGO
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    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.3.4Pharmaceutical form Solution for injection
    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 INNnd
    D.3.9.1CAS number nd
    D.3.9.2Current sponsor coderadium223
    D.3.9.3Other descriptive nameRADIUM RA 223 DICHLORIDE
    D.3.9.4EV Substance CodeSUB129907
    D.3.10 Strength
    D.3.10.1Concentration unit kBq kilobecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number55
    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 Yes
    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
    Patients with mCRPC with asymptomatic progression while on abiraterone acetate or enzalutamide
    Pacientes con CPRCm con progresión asintomática durante el tratamiento con acetato de abiraterona o enzalutamida
    E.1.1.1Medical condition in easily understood language
    Patients with mCRPC with asymptomatic progression while on abiraterone acetate or enzalutamide
    Pacientes con CPRCm con progresión asintomática durante el tratamiento con acetato de abiraterona o enzalutamida
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of radium-223 in asymptomatic patients with mCRPC who have progressed while on abiraterone acetate or enzalutamide treatment.
    Evaluar la eficacia del radio 223 en pacientes asintomáticos con CPRCm que haya progresado durante el tratamiento con acetato de abiraterona o enzalutamida
    E.2.2Secondary objectives of the trial
    • Safety profile.
    • To determine the association between AR-V7 status (positive vs. negative) and progression-free survival (PFS).
    • To establish the relationship between circulating tumor cells (CTCs) number and ctDNA levels with radium-223 efficacy.
    • Perfil de seguridad.
    • Determinar la asociación entre el estado del gen AR­V7 (positivo frente a negativo) y la supervivencia libre de progresión (PFS).
    • Establecer la relación entre el número de células tumorales circulantes (CTC) y la eficacia del radio 223.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is an adult ≥ 18 years at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
    • Subject has histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
    • Subject has bone metastases due to the prostate cancer and absence of visceral metastases.
    • Subject has a serum testosterone of ≤ 1.7 nmol/L (or ≤ 50 ng/dL) at screening.
    • Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate or enzalutamide within its approved label indication and has discontinued use at least four weeks prior to start of study drug at day 1.
    • Prior use of docetaxel is allowed in castration-naïve patients (maximum of six cycles).
    • Subject receives and will continue to receive ongoing androgen deprivation with luteinizing releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
    • Subject is asymptomatic from prostate cancer, defined as patients with the score on brief pain inventory (short form) (BPI-SF) Question #3 must be zero or one and no use of opiate analgesics for prostate cancer-related pain currently or anytime within two weeks prior to screening.
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 at screening.
    • Subject receiving bisphosphonate or other approved bone-targeting therapy must have been on stable doses for at least four weeks prior to start of study drug at day 1.
    • Subject has a life expectancy of more than or equal to 12 months.
    • Subject agrees not to participate in another interventional study while on study drug.
    • Subject and his female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for six months after final study drug administration.
    • Pacientes adultos ≥ 18 años de edad en el momento en que se obtenga el consentimiento informado y que lo hayan firmado antes de realizar cualquier actividad relacionada con el ensayo y según las directrices locales.
    • Pacientes con adenocarcinoma de próstata histológicamente confirmado sin diferenciación neuroendocrina ni componente de células pequeñas.
    • Pacientes con metástasis óseas a causa del cáncer de próstata y ninguna metástasis visceral.
    • Pacientes con un nivel de testosterona sérica ≤ 1,7 nmol/l (o ≤ 50 ng/dl) en la selección.
    • Pacientes que hayan recibido durante un mínimo de 24 semanas tratamiento con acetato de abiraterona o enzalutamida para la indicación aprobada en la ficha técnica y que hayan suspendido su uso al menos 4 semanas antes del inicio del fármaco del estudio el día 1.
    • Se permite el uso previo de docetaxel en pacientes que no se hayan sometido a ninguna castración (en un máximo de seis ciclos).
    • Pacientes que reciban y tengan previsto continuar recibiendo terapia de privación de andrógenos con tratamiento análogo con hormona liberadora de hormona luteinizante (LHRH) durante el curso del estudio o que se hayan sometido a una orquiectomía bilateral.
    • Pacientes sin síntomas de cáncer de próstata, definidos como pacientes con una puntuación de cero o uno en la pregunta n.º 3 del inventario abreviado de dolor (BPI-SF) y que no estén recibiendo actualmente ningún analgésico opiáceo para el dolor relacionado con el cáncer de próstata ni lo hayan recibido en ningún momento durante las dos semanas anteriores a la selección.
    • Pacientes con un estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 - 1 en la selección
    • Pacientes que estén recibiendo bifosfonatos o cualquier otro tratamiento aprobado para los huesos con dosis estables durante al menos cuatro semanas antes del inicio del fármaco del estudio el día 1.
    • Pacientes con una esperanza de vida igual o superior a 12 meses.
    • Sujetos que no acepten participar en otro estudio de intervención mientras estén tomando el fármaco del estudio.
    • Los Pacientes y sus parejas (mujeres) en edad fértil deben utilizar dos métodos anticonceptivos aceptables (uno de los cuales debe incluir un preservativo como método de barrera) desde la selección y a lo largo de todo el periodo del estudio, y durante los seis meses posteriores a la administración final del fármaco del estudio.
    E.4Principal exclusion criteria
    Any patient meeting ANY of the following criteria will be excluded from the study:
    • Subject has received any anti-neoplastic therapy (including ketokonazol and chemotherapy) following abiraterone acetate or enzalutamide discontinuation and prior to start of study drug at day 1.
    • Subject has known or suspected brain metastases or active leptomeningeal disease.
    • Subject has concurrent disease or any clinically significant abnormality following the investigator’s review of the physical examination and safety laboratory tests at screening, which in the judgment of the investigator would interfere with the subject's participation in this study or evaluation of study results.
    • Subject has a history of another invasive cancer within three years prior to screening, with the exceptions of non-melanoma skin cancers or a non-infiltrating muscle bladder cancer that have a remote probability of recurrence in the opinion of the investigator in consultation with the medical monitor.
    • Subject had major surgery within one month prior to screening.
    • Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to start of study drug at day 1.
    • Subject has absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, and hemoglobin < 6.25 mmol/L (or < 10 g/dL) at screening (Note: Subjects must not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at screening).
    • Subject has total bilirubin > 1.5 times the upper limit of normal (ULN) at screening, except for subjects with documented Gilbert’s syndrome.
    • Subject has creatinine > 2.5 mg/dL at screening.
    • Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL) at screening.
    Los pacientes que cumplan ALGUNO de los siguientes criterios quedarán excluidos del estudio:
    • Pacientes que estén recibiendo tratamiento antineoplásico (incluido ketokonazol y quimoterapia) tras la retirada de acetato de abiraterona o enzalutamida y antes del inicio del fármaco del estudio el día 1.
    • Pacientes con metástasis cerebrales o enfermedad leptomeníngea activa o sospecha de las mismas.
    • Pacientes con enfermedad concomitante o alguna anomalía clínicamente significativa tras la revisión de la exploración física por parte del investigador y las pruebas analíticas de seguridad en la selección, lo que según el criterio del investigador interferiría en la participación en este estudio por parte del sujeto o en la evaluación de los resultados del estudio.
    • Pacientes con antecedentes de otro cáncer invasivo durante los tres últimos años antes de la selección, salvo cánceres cutáneos no melanomatosos o cáncer de vejiga no infiltrante que presenten una remota probabilidad de recurrencia según el criterio del investigador y del monitor médico.
    • Pacientes con cirugía mayor durante el mes anterior a la selección.
    • Pacientes que hayan recibido tratamiento en investigación durante los 28 días o 5 vidas medias anteriores, aquel periodo que sea más largo, antes del inicio del fármaco del estudio.
    • Pacientes con un recuento absoluto de neutrófilos < 1500/μl, recuento de plaquetas < 100 000/μl y hemoglobina < 6,25 mmol/l (o < 10 g/dl) en la selección (Nota: Sujetos que no hayan recibido factores de crecimiento ni transfusiones de sangre durante los siete días anteriores a la obtención de los valores de laboratorio hematológicos en la selección).
    • Pacientes con bilirrubina total > 1,5 veces el límite superior normal (LSN) en la selección, salvo los sujeto con síndrome de Gilbert documentado.
    • Pacientes con un valor de creatinina > 2,5 mg/dl en la selección.
    • Pacientes con un valor de albúmina ≤ 30 g/l (o ≤ 3,0 g/dl) en la selección
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to assess the efficacy of radium-223 in terms of radiological rPFS.
    La variable principal de este estudio es evaluar la eficacia del radio 223 en términos de rPFS radiológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is a
    composite endpoint defined as the time from the start of the radium-223 treatment to disease
    progression in bone or soft-tissue, symptoms, or death, according to the PCWG2 criteria.
    Objective radiographic disease progression is defined as the presence of at least one of the
    following conditions:
    • Bone lesion progression (appearance of ≥ two new bone lesions compared to baseline).
    • Soft-tissue lesion progression according to the RECIST criteria version 1.1.
    • Presence of skeletal events.
    SLP es un criterio de valoración compuesto definido como el tiempo desde el inicio del tratamiento radio-223 a la progresión de la enfermedad en el hueso o tejido blando, los síntomas, o la muerte, de acuerdo con los criterios PCWG2.
    La progresión de la enfermedad objetiva radiográfica se define como la presencia de al menos una de las siguientes condiciones:
    • progresión de la lesión ósea (≥ aparición de dos nuevas lesiones óseas en comparación con el valor basal).
    • progresión de la lesión de los tejidos blandos de acuerdo con los criterios RECIST versión 1.1.
    • Presencia de eventos esqueléticos.
    E.5.2Secondary end point(s)
    Safety
    AEs will be evaluated using the NCI-CTCAE version 4.0. Grade 3 or 4 AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the various combinations of drugs.

    Efficacy
    • Radiographic progression-free survival (rPFS) depending on AR-V7 status.
    • Overall survival (OS).
    • Time to first symptomatic skeletal-related event (SRE).
    • Time to PSA response according to the ALSYMPCA study criteria.
    • Determination percentage of PSA response.
    • Alkaline phosphatase level response (AF), normalization of alkaline phosphatase level, according to the ALSYMPCA study criteria.

    Molecular aspects
    • Assessment of AR-V7 mutation evolution during the study treatment.
    • Determination changes in CTCs number and ctDNA levels during the study treatment.
    Seguridad
    Se evaluarán los AA utilizando los CTCAE del NCI versión 4.0. Se evaluarán los AA de grado 3 o 4 y los acontecimientos adversos graves (AAG) para determinar la seguridad y la tolerancia de las distintas combinaciones de fármacos.
    Eficacia
    • Supervivencia libre de progresión radiográfica (rPFS) dependiendo del estado del gen AR-V7.
    • Supervivencia global (OS).
    • Tiempo hasta el primer acontecimiento esquelético sintomático (AES).
    • Tiempo hasta la progresión del PSA según los criterios ALSYMPCA del estudio.
    • Determinación del porcentaje de progresión del PSA.
    • Respuesta del nivel de fosfatasa alcalina (FA), normalización del nivel de fosfatasa alcalina según los criterios ALSYMPCA del estudio.
    Aspectos moleculares
    • Evaluación de la evolución de la mutación del gen AR-V7 durante el tratamiento del estudio.
    • Determinación de los cambios en el número de CTC durante el tratamiento del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety will be evaluated continuosly during all study.
    Efficacy will be evaluated globally after the conclusion of data entry in the CRF and locally by each investigator taking into account the clinic benefit for each patient, case by case
    a seguridad se evalúa continuamente durante todo el estudio.
    La eficacia se evalúe a nivel mundial después de la conclusión de la entrada de datos en el formulario común y localmente por cada investigador teniendo en cuenta el beneficio clínico de cada paciente, caso por caso.
    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 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.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.8.3 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 No
    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 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
    Last Visit Last Patient
    Ultima Visita del Ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A Legal representative Informed consent will be obtained
    En estos casos se obtendrá un CI del Representante legal del paciente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    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)
    Patients may continue receiving commercial radium-223 (Xofigo®), if it is found to offer clinical benefits in the opinion of the investigator
    Pacientes podrán continuar recibiendo Xofigo (Radio-223) comercial, si en opinion del investigador, sigue ofreciendo beneficios clinicos para ellos
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-28
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 20:37:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA