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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-002408-26
    Sponsor's Protocol Code Number:42756493BLC2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-16
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio in aperto, multicentrico, a due bracci, di fase 2 per determinare l'efficacia e la sicurezza di due diversi regimi di dosaggio di JNJ-42756493, un pan-inibitore della tirosin-chinasi FGFR, in soggetti con carcinoma uroteliale metastatico o non asportabile chirurgicamente con alterazioni genomiche dell’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
    Uno Studio di efficacia e sicurezza su JNJ-42756493 in soggetti con carcinoma uroteliale
    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 International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 21 66
    B.5.5Fax number+3171524 21 10
    B.5.6E-mailClinicalTrialsEU@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
    Carcinoma uroteliale
    E.1.1.1Medical condition in easily understood language
    Bladder cancer
    Cancro della vescica
    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.
    • Valutare il tasso di risposta oggettiva (risposta completa [CR]+ risposta parziale [PR]) del regime di dosaggio selezionato tra 2 possibili regimi (regime 1: dose da 10 mg, 7 giorni sì/7 giorni no; e regime 2: dose da 6 mg, 21 giorni sì/7 giorni no) in soggetti con carcinoma uroteliale metastatico o non asportabile chirurgicamente, caratterizzati da specifiche alterazioni genomiche dell’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
    • Valutare il tasso di risposta oggettiva nei soggetti refrattari a chemioterapia.
    • Valutare la sopravvivenza senza progressione (PFS), la durata della risposta e la sopravvivenza globale in tutti i soggetti e nei soggetti refrattari a chemioterapia.
    • Valutare il tasso di risposta in sottogruppi specifici per biomarcatori (traslocazioni vs. mutazioni).
    • Valutare la sicurezza e la farmacocinetica di JNJ-42756493 nei 2 regimi di dosaggio.
    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
    - Presenza dimostrata istologicamente di carcinoma uroteliale metastatico o non asportabile chirurgicamente. Sono accettabili componenti minori di variante istologica come una differenziazione squamosa o ghiandolare oppure evoluzione a fenotipi più aggressivi come la variante sarcomatoide o micropapillare.
    - Malattia misurabile in base ai criteri di valutazione della risposta nei tumori solidi (RECIST, versione 1.1) al basale.
    - Punteggio del performance status ECOG pari a 0, 1 o 2 (Allegato 1 al protocollo di studio
    - Funzionalità midollare, epatica e renale adeguata, come descritto nel protocollo.
    - Test di gravidanza negativo (beta-hCG nel siero o nell'urina) allo screening per donne potenzialmente fertili e sessualmente attive.
    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)
    1. Trattamenti precedenti di chemioterapia, terapie mirate, radioterapia definitiva, immunoterapia o trattamento con un agente antitumorale sperimentale nelle 2 settimane (in caso di nitrosuree e mitomicina C nelle 6 settimane) precedenti la prima somministrazione del farmaco sperimentale.
    Sono ammessi radioterapia palliativa localizzata (che non deve comprendere radiazioni alle lesioni target) e trattamento in corso con bifosfonati e denosumab.

    2. Livello persistente di fosfato > ULN durante lo screening (entro 14 giorni dal trattamento e prima del Giorno 1 del Ciclo 1) e nonostante le cure medica.

    3. Anamnesi o presenza di patologia cardiovascolare incontrollata
    4. Donne in stato di gravidanza o in fase di allattamento o che prevedono una gravidanza entro tre mesi dall'ultima dose del farmaco sperimentale e uomini che pianificano il concepimento di un figlio durante l'arruolamento nel presente studio o entro i 5 mesi successivi all'ultima dose di farmaco dello studio.
    5. Mancato recupero da tossicità reversibile causata da una precedente terapia antitumorale (tranne tossicità non clinicamente significative, come alopecia, scolorimento della pelle o neuropatia di grado 1).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants with Best Overall Response
    Percentuale di partecipanti con la miglior risposta globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    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. Sopravvivenza libera da progressione
    2. Durata della risposta
    3. Sopravvivenza globale
    4. Numero di partecipanti con eventi avversi (AEs) ed eventi avversi seri (SAEs)
    5. Valutazione biomarkers
    6. Concentrazione plasmatica di JNJ 42756493
    7. Clearance plasmatica di JNJ 42756493
    8. Volume di distribuzione di 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. Dalla data della prima dose di trattamento in studio fino a progressione di malattia o decesso valutato fino all’ultima valutazione di efficacia per progressione di malattia (ca. 3 anni e 9 mesi)
    3. Dalla data della prima dose di trattamento in studio fino al decesso (fino a 3 anni e 9 mesi)
    4. Dallo screening fino alla fine dello studio (ca. 3 anni e 9 mesi)
    5/6/7/8 Dalla baseline fino alla fine dello studio (ca. 3 anni e 9 mesi)
    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
    Test dei biomarcatori
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 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.
    La fine dello studio è approssimativamente 12 mesi dopo l'arruolamento dell'ultimo soggetto o quando lo Sponsor decide di terminare lo studio
    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 months7
    E.8.9.1In the Member State concerned days
    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.
    Non verrà fornito alcun trattamento aggiuntivo o cura. I pazienti saranno monitorati per la sopravvivenza e per gli eventi avversi considerati possibilmente correlati al farmaco in studio fino all’inizio della nuova 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 Decision2015-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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