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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41229   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-002408-26
    Sponsor's Protocol Code Number:42756493BLC2001
    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:2015-03-03
    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 number2014-002408-26
    A.3Full title of the trial
    A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations
    Estudio Fase 2 de dos grupos, multicéntrico y abierto para determinar la eficacia y la seguridad de dos pautas posológicas diferentes de JNJ-42756493, un pan-inhibidor tirosina quinasa del FGFR, en sujetos con cáncer urotelial metastásico o no resecable quirúrgicamente con alteraciones genómicas del FGFR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of JNJ-42756493 in Participants with Urothelial Cancer
    Estudio de eficacia y seguridad de JNJ-42756493 en sujetos con cáncer urotelial.
    A.4.1Sponsor's protocol code number42756493BLC2001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag SA
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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.3.1Product nameJNJ-42756493 5 mg tablets
    D.3.2Product code JNJ-42756493 5 mg tablets
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-42756493
    D.3.9.3Other descriptive nameR601230
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.3.1Product nameJNJ-42756493 4 mg tablets
    D.3.2Product code JNJ-42756493 4 mg tablets
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-42756493
    D.3.9.3Other descriptive nameR601230
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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.3.1Product nameJNJ-42756493 3 mg tablets
    D.3.2Product code JNJ-42756493 3 mg tablets
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-42756493
    D.3.9.3Other descriptive nameR601230
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Urothelial cancer
    Cáncer urotelial
    E.1.1.1Medical condition in easily understood language
    Bladder cancer
    Cáncer de vejiga
    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 PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder 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
    The primary objective of the study is:
    * To evaluate the objective response rate of the selected dose regimen out of 2 possible dose regimens (Regimen 1: 10 mg dose, 7 days on/7 days off; and regimen 2: 6 mg dose, 21 days on/7 days off) in subjects with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.
    El objetivo primario del estudio es:
    * Evaluar la tasa de respuesta objetiva con la pauta posológica elegida entre 2 posibles pautas posológicas (Pauta 1: dosis de 10 mg, 7 días con medicación / 7 días de descanso; y pauta 2: dosis de 6 mg, 21 días con medicación / 7 días de descanso) en pacientes con cánceres uroteliales metastásicos o quirúrgicamente irresecables que presenten alteraciones genómicas específicas del FGFR.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    * To evaluate the objective response rate in chemo-refractory subjects
    * To evaluate the progression-free survival (PFS), duration of response, and overall survival in all and chemo-refractory subjects
    *To evaluate the response rate in biomarker-specific subgroups (translocations versus mutations)
    * To evaluate the safety and pharmacokinetics of JNJ-42756493 at the 2 dose regimens
    Los objetivos secundarios del estudio son:
    *Evaluar la tasa de respuesta objetiva en pacientes resistentes a la quimioterapia.
    *Evaluar la supervivencia libre de progresión (SSP), la duración de la respuesta y la supervivencia global en todos los pacientes y en los pacientes resistentes a la quimioterapia.
    *Evaluar la tasa de respuesta en subgrupos con biomarcadores específicos (translocaciones frente a mutaciones).
    *Evaluar la seguridad y la farmacocinética de JNJ-42756493 en las 2 pautas posológicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
    - Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
    - Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1, or 2
    - Must have adequate bone marrow, liver, and renal function as described in protocol
    - Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at Screening for women of child bearing potential who are sexually active
    - Deben tener confirmación histológica de cancer urotelial metastásico o quirúrgicamente irresecable. Se aceptan componentes menores de variantes histológicas tales como la diferenciación glandular o escamosa, o evolución a fenotipos más agresivos como carcinoma sarcomatoide o cambio micropapilar.
    - En la selección, deben tener enfermedad medible de acuerdo a los Criterios de Evaluación de Respuesta en Tumores Sólidos (RECIST, versión 1.1).
    - Deben tener un estado funcional del ?Eastern Cooperative Oncology Group? (ECOG) de 0, 1, o 2
    - Deben tener una función medular, hepática y renal adecuada, como se describe en el protocolo.
    - Prueba de embarazo negativa (beta gonadotropina coriónica humana [b-hCG] en orina o suero) en el momento de la selección para mujeres en edad fértil y sexualmente activas.
    E.4Principal exclusion criteria
    - Received chemotherapy, targeted therapies, definitive radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and mitomycin C, within 6 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
    - Has persistent phosphate level greater than upper limit of normal (ULN) during
    screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
    - Has a history of or current uncontrolled cardiovascular disease
    - Females who are pregnant, breast-feeding, or planning to become pregnant within 3 months after the last dose of study drug and males who plan to father a child while enrolled in this study or within 5 months after the last dose of study drug
    - Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade 1 neuropathy)
    - Haber recibido quimioterapia, terapias dirigidas, radioterapia definitiva, inmunoterapia o tratamiento con un fármaco antitumoral en investigación en las 2 semanas previas (en el caso de nitrosureas y mitomicina C, en las 6 semanas previas) a la primera administración del fármaco del estudio. Se permiten terapia con radiación paliativa localizada (pero no debe incluir radiación en la lesión diana) y tratamiento actual con bifosfonatos y denosumab.
    - Tener persistentes niveles de fosfato por encima del límite superior de normalidad durante la selección (durante los 14 días previos al tratamiento del Ciclo 1 Día 1), a pesar del manejo médico.
    - Tener o haber tenido enfermedad cardiovascular no-controlada.
    - Mujeres embarazadas o que estén amamantando, o que tengan planeado quedarse embarazadas durante los tres meses siguientes a haber recibido la última dosis del fármaco del estudio. Hombres que tengan planeado ser padres durante el estudio o en los 5 meses siguientes a haber tomado la última dosis del fármaco del estudio.
    - No haberse recuperado de una toxicidad reversible debida a un tratamiento antitumoral previo (excepto toxicidades que no sean clínicamente significativas tales como alopecia, decoloración de la piel, o neuropatía Grado 1).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants with Best Overall Response
    Porcentaje de sujetos con la mejor respuesta global.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año.
    E.5.2Secondary end point(s)
    1. Progression-free survival
    2. Duration of Response
    3. Overall survival
    4. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    5. Biomarker Assessment
    6. Plasma Concentration of JNJ 42756493
    7. Plasma Clearance of JNJ 42756493
    8. Volume of Distribution of JNJ 42756493
    1. Supervivencia libre de progresión.
    2. Duración de la respuesta.
    3. Supervivencia global.
    4. Número de Sujetos con Eventos Adversos (AEs) y Eventos Adversos Serios (SAEs).
    5. Análisis de biomarcadores.
    6. Concentración plasmática de JNJ 42756493.
    7. Aclaramiento plasmático de JNJ 42756493.
    8. Volumen de distribución de JNJ 42756493.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/2. From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approx 3yrs 9m)
    3. From the date of the first dose of study drug until death (up to 3yrs 9m)
    4. Screening up to end of study (approx 3yrs 9m)
    5/6/7/8. Baseline up to end of study (approx 3 years 9 months)
    1/2. Desde la fecha de la administración de la primera dosis del fármaco del estudio hasta progresión de la enfermedad o muerte medida hasta el último análisis de eficacia para la progresión de la enfermedad (aproximadamente 3 años y 9 meses).
    3. Desde la fecha de la administración de la primera dosis del fármaco del estudio hasta la muerte (hasta 3 años y 9 meses).
    4. Desde la selección hasta el fin de estudio (aproximadamente 3 años y 9 meses).
    5/6/7/8. Desde el momento basal hasta el fin de estudio (aproximadamente 3 años y 9 meses).
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker testing
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    A different dosage of the same product
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Belgium
    France
    Germany
    Italy
    Korea, Republic of
    Romania
    Russian Federation
    Spain
    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
    The end of study is defined as approximately 12 months after last subject is enrolled or anytime the Sponsor terminates the study.
    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 months0
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 165
    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)
    No additional treatment or care will be provided. Patients will be followed for survival and adverse events considered possibly related to study drug until the start of the new therapy.
    No se proporcionará ningún tratamiento o la atención adicional. Se hará seguimiento de la supervivencia de los pacientes y los acontecimientos adversos posiblemente relacionados con el fármaco en estudio hasta el comienzo de una nueva terapia.
    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 Decision2015-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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