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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2014-001745-25
    Sponsor's Protocol Code Number:CC-486-NPC-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001745-25
    A.3Full title of the trial
    A Phase 2, Multicenter, International, Single Arm Study to Assess the Safety and Efficacy of Single Agent CC-486 (Oral Azacitidine) in Previously Treated Subjects With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
    Studio di fase 2, multicentrico, internazionale, a braccio singolo, per valutare la sicurezza e l’efficacia di CC-486 (AZACITIDINA orale) somministrato in monoterapia in soggetti con carcinoma nasofaringeo localmente avanzato o metastatico precedentemente trattati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, worldwide study conducted to see if patients with cancer in the area behind the nose and above the back of the throat can benefit from treatment with a single drug called CC-486 (Oral Azacitidine). This study will also test the safety of the drug while patients are taking it.
    Studio globale di Fase 2 condotto per capire se i pazienti con tumore nella parte posteriore del naso e sopra il retro della gola possano trarre beneficio dal trattamento con un singolo farmaco denominato CC-486 (azacitidina orale). Questo studio testerà anche la sicurezza del farmaco durante l’assunzione da parte dei pazienti.
    A.4.1Sponsor's protocol code numberCC-486-NPC-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02269943
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888260 1599
    B.5.5Fax number+1913266 0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated 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 INNAZACITIDINA
    D.3.9.4EV Substance CodeSUB05624MIG
    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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated 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 INNAZACITIDINA
    D.3.9.4EV Substance CodeSUB05624MIG
    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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated 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 INNAZACITIDINA
    D.3.9.4EV Substance CodeSUB05624MIG
    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
    Locally advanced or metastatic nasopharyngeal carcinoma
    Carcinoma nasofaringeo localmente avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Cancer in the area behind the nose and above the back of the throat that has come back after receiving standard treatment
    Tumore della parte posteriore del naso e sopra il retro della gola che si è ripresentato dopo la somministrazione della terapia standard.
    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 LLT
    E.1.2Classification code 10028793
    E.1.2Term Nasopharyngeal carcinoma
    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
    To evaluate the efficacy of CC-486 in patients with nasopharyngeal carcinoma (NPC)
    Valutare l’efficacia di CC-486 in pazienti con carcinoma nasofaringeo (nasopharyngeal carcinoma, NPC).
    E.2.2Secondary objectives of the trial
    - To evaluate safety in all patients
    - To evaluate pharmacokinetics of CC-486 in a subset of patients of Asian-Pacific Island ethnicity
    - Valutare la sicurezza in tutti i pazienti.
    - Valutare la farmacocinetica di CC-486 in un sottogruppo di pazienti con etnia delle isole del Pacifico asiatico.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Pharmacokinetic sample collection in a subset of enrolled patients of Asian-Pacific Island ethnicity
    - Biomarker samples collection (stage I of the study as per protocol)
    - Raccolta di campioni per l’analisi farmacocinetica in un sottogruppo etnico di pazienti arruolati con etnia delle isole del Pacifico asiatico.
    - Raccolta di campioni per l’analisi dei biomarcatori (stadio I dello studio come da protocollo).
    E.3Principal inclusion criteria
    - Age = or > 18 years.
    - Histological or cytological diagnosis of undifferentiated or poorly differentiated nasopharyngeal carcinoma that is locally advanced or metastatic.
    - Disease progression either clinically or radiographically after 1 to 2 previous regimens.
    - Patient has received a platinum containing regimen.
    - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    - Radiographically-documented measurable disease.
    - Adequate organ and bone marrow functions.
    - Willingness to follow pregnancy precautions.
    - Età ≥ 18 anni.
    - Diagnosi istologica o citologica di carcinoma nasofaringeo indifferenziato o scarsamente differenziato che sia localmente avanzato o metastatico.
    - Progressione di malattia a livello clinico o radiologico dopo 1-2 pregressi regimi di trattamento.
    - Paziente che ha ricevuto un regime contenente platino.
    - ECOG (Eastern Cooperative Oncology Group) performance status da 0 a 2.
    - Malattia misurabile e documentata a livello radiologico.
    - Funzioni d’organo e del midollo osseo adeguate.
    - Volontà di seguire le precauzioni per la prevenzione della gravidanza.
    E.4Principal exclusion criteria
    - History of, or current brain metastasis.
    - Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer
    - Previous treatment with azacitidine (any formulation), decitabine, or any other hypomethylating agent.
    - Impaired ability to swallow oral medication.
    - Persistent diarrhea or malabsorption.
    - Major surgery within 14 days prior to starting investigational product or has not recovered from major side effects.
    - Another investigational therapy within 28 days or 5 half lives of randomization/enrollment, whichever is shorter.
    - Patient has not recovered from the acute toxic effects of prior anticancer therapy, radiation, or major surgery/significant trauma.
    - Radiotherapy < or = 4 weeks or limited field radiation for palliation < or = 2 weeks prior to starting with the investigational product.
    - Any condition that places the patient at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
    - Metastasi cerebrale pregressa o attuale.
    - Qualsiasi altro tumore maligno nei 5 anni precedenti la randomizzazione, con l’eccezione del carcinoma in situ adeguatamente trattato della cervice, dell’utero, oppure carcinoma cutaneo non melanomatoso (per il quale tutti i trattamenti devono essere stati completati 6 mesi prima dell’arruolamento), carcinoma mammario a cellule squamose in situ o carcinoma prostatico incidentale.
    - Precedente trattamento con azacitidina (qualsiasi formulazione), decitabina o qualsiasi altro agente ipometilante.
    - Storia di patologia o difetto gastrointestinale
    - Ridotta capacità di ingoiare un farmaco orale.
    - Diarrea persistente o malassorbimento.
    - Patologia cardiaca in atto
    - Infezione da virus dell’immunodeficienza umana (human deficiency virus, HIV)
    - Emorragia in atto; patologia che comporta un elevato rischio di emorragia; rischio di pseudoaneurisma dell’arteria carotide interna e sindrome da rottura acuta della carotide
    - Intervento chirurgico maggiore nei 14 giorni precedenti l’avvio della terapia con l’IP o mancato recupero in seguito a effetti collaterali importanti.
    - Altra terapia sperimentale nei 28 giorni o 5 emivite precedenti la randomizzazione/l’arruolamento, in base a quale fase sia più breve.
    - Il paziente non si è ripreso dagli effetti tossici acuti di una precedente terapia antitumorale, con radiazioni o di un intervento chirurgico maggiore/grave trauma.
    - Radioterapia ≤ 4 settimane o radiazioni a campo limitato per scopi palliativi ≤ 2 settimane prima dell’avvio della terapia con il prodotto sperimentale.
    - Gravidanza o allattamento
    - Qualsiasi condizione che esponga il paziente a un rischio inaccettabile in caso di partecipazione allo studio o che comprometta la capacità di interpretare i dati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall response rate (ORR)
    - Progression-free survival (PFS)

    1

    Tasso di rispo
    2

    Sopravvivenza libera da progressione (progression-free survival, PFS) sta complessiva (overall response rate, ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - ORR and PFS: at screening within 28 days before the start of the Investigational Product and after that every 6 weeks (± 5 days) from Cycle 1 Day 1, for the first three tumor evaluations and then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent
    1) allo screening nei 28 giorni prima dell’avvio della terapia con il prodotto sperimentale e, in seguito, ogni 6 settimane (± 5 giorni) dal Ciclo 1 Giorno 1, per le prime tre valutazioni tumorali e successivamente ogni 9 settimane fino alla progressione di malattia o all’inizio di un nuovo trattamento antitumorale o alla revoca del consenso.
    2) allo screening nei 28 giorni prima dell’avvio della terapia con il prodotto sperimentale e, in seguito, ogni 6 settimane (± 5 giorni) dal Ciclo 1 Giorno 1, per le prime tre valutazioni tumorali e successivamente ogni 9 settimane fino alla progressione di malattia o all’inizio di un nuovo trattamento antitumorale o alla revoca del consenso.
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Safety
    - Pharmacokinetics (PK) in a subset of patients of Asian-Pacific Island ethnicity
    1
    Sopravvivenza complessiva (overall survival, OS)

    2 Sicurezza

    3) Farmacocinetica (pharmacokinetics, PK) in un sottogruppo di pazienti con etnia delle isole del Pacifico asiatico.

    4)
    Tasso di controllo della malattia (Disease Control Rate, DCR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - OS: continuously during the trial and every 8 weeks (+/- 5 days) in the Follow-up Period
    - Safety: continuously starting after informed consent signature, until 28 days after treatment discontinuation
    - PK in a subset of patients of Asian-Pacific Island ethnicity: On each PK day prior to each dose administration and afterwards at 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, and 8h post-dose
    1) in modo continuativo durante la sperimentazione e ogni 8 settimane (+/- 5 giorni) nel Periodo di follow-up.
    2)
    in modo continuativo, iniziando dalla firma del modulo di consenso informato e fino a 28 giorni dopo l’interruzione del trattamento.
    3)
    PK in un sottogruppo di pazienti con etnia delle isole del Pacifico asiatico: ogni giorno fissato per le analisi PK prima della somministrazione di ciascuna dose e in seguito, a 0,25h, 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 3,5h, 4h, 6h e 8 ore post-dose.
    4) ogni 2 cicli fino a progressione della malattia oppure fino ad almeno 16 settimane per i soggetti senza progressione di malattia o con malattia stabile
    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 No
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Canada
    France
    Greece
    Hong Kong
    Italy
    Romania
    Singapore
    Spain
    Taiwan
    Tunisia
    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
    Either LVLS or the date of receipt of the last data point from the last patient that is required for primary, secondary, and/or exploratory analysis and/or the Statistical Analysis Plan, whichever is the later date.
    Ultima visita dell’ultimo soggetto (Last Visit of Last Subject, LVLS) o la data di ricezione dell’ultimo valore dall’ultimo paziente necessario per l’analisi primaria, secondaria e/o esplorativa e/o per il Piano di analisi statistica, a seconda di quale data venga per ultima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 55
    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)
    In accordance to the patient's respective treating physician's standard of care.
    In accordo allo standard di cura del medico curante del paziente.
    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 Decision2015-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Sat Apr 27 00:37:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA