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    The EU Clinical Trials Register currently displays   44200   clinical trials with a EudraCT protocol, of which   7332   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).

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    Summary
    EudraCT Number:2014-001745-25
    Sponsor's Protocol Code Number:CC-486-NPC-001
    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:2014-11-25
    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 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
    Estudio de fase 2, multicéntrico, internacional y de un único grupo, para evaluar la seguridad y la
    eficacia de CC-486 (azacitidina oral) en monoterapia en sujetos con carcinoma nasofaríngeo
    localmente avanzado o metastásico tratados previamente
    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.
    Estudio Fase 2, llevado a cabo en todo el mundo para ver si los pacientes con cáncer en el área detrás de la nariz y por encima de la parte de atrás de la garganta pueden beneficiarse del tratamiento con un solo medicamento llamado CC-486 (azacitidina oral). Este estudio también pondrá a prueba la seguridad del medicamento, mientras que los pacientes lo están tomando.
    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+3491422 90 00
    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 nameAzacitidina oral
    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.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameAzacitidina oral
    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.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameAzacitidina oral
    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.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 nasofaríngeo (CNF) localmente avanzado o metastásico
    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
    Cáncer en el área detrás de la nariz y por encima de la parte posterior de la garganta que ha vuelto a aparecer después de recibir el tratamiento estándar
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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)
    Evaluar la eficacia de CC-486 en sujetos con CNF.
    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
    Evaluar la seguridad en todos los sujetos
    Evaluar la farmacocinética (FC) de CC-486 en un subgrupo de sujetos del grupo étnico con ascendencia asiática y de las islas del Pacífico
    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)
    - Recogida de muestras farmacocinéticas en un subgrupo de sujetos del grupo étnico con ascendencia asiática y de las islas del Pacífico
    - Recogidas de muestras de biomarcadores (etapa I del estudio según protocolo)
    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.
    - Edad mínima de 18 años en el momento de firmar el documento de consentimiento
    informado.
    - Diagnóstico histológico o citológico de carcinoma nasofaríngeo indiferenciado o poco
    diferenciado que esté localmente avanzado o sea metastásico
    - Progresión clínica o radiológica de la enfermedad después de 1 o 2 tratamientos previos
    - Recepción previa de un tratamiento con platino.
    - Estado funcional del ECOG de 0 a 2
    - Enfermedad mensurable documentada radiológicamente
    - Funciones orgánicas y medulares adecuadas
    - Disposición para cumplir con las precauciones de embarazo
    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.
    - Antecedentes o presencia de metástasis cerebrales
    - Presencia de cualquier otra neoplasia maligna en los 5 años previos a la aleatorización, a
    excepción de un carcinoma in situ de cuello uterino, cáncer de útero o cáncer de piel
    distinto del melanoma debidamente tratado (todo el tratamiento tendrá que haberse
    completado 6 meses antes de la inclusión), carcinoma epidermoide in situ de mama o
    cáncer de próstata incidental
    - Tratamiento previo con azacitidina (cualquier formulación), decitabina u otro fármaco
    hipometilante.
    - Alteración de la capacidad de tragar medicación oral
    - Presencia de diarrea o malabsorción persistente
    - Práctica de una intervención de cirugía mayor en los 14 días previos al inicio del
    tratamiento con el PEI o ausencia de recuperación de efectos secundarios importantes
    - Recepción de otro tratamiento en investigación en los 28 días previos a la
    aleatorización/inclusión, o el equivalente a 5 semividas, lo que suponga menos tiempo
    - Ausencia de recuperación de los efectos tóxicos agudos de un tratamiento antineoplásico
    o radioterapia previa o de una intervención de cirugía mayor o traumatismo importante
    - Recepción de radioterapia <= 4 semanas o de radioterapia de campo limitado con fines
    paliativos <= 2 semanas antes de empezar a tomar el PEI
    - Presencia de cualquier situación que entrañaría un riesgo inaceptable para el sujeto en caso de que participara en el estudio o que altere la capacidad de interpretar los datos del
    estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall response rate (ORR)
    - Progression-free survival (PFS)
    - Tasa de Respuesta Global (TRG)
    - Supervivencia Libre de Progresión (SLP)
    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
    - TRG y SLP: en el screening dentro de los 28 días antes del inicio del producto en investigación y después de eso cada 6 semanas (+- 5 días) desde el día 1 del ciclo 1 durante las tres primeras evaluaciones del tumor y, posteriormente, cada 9 semanas hasta que se produzca progresión de la enfermedad, inicio de un nuevo tratamiento antineoplásico o retirada del consentimiento
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Safety
    - Pharmacokinetics (PK) in a subset of patients of Asian-Pacific Island ethnicity
    - Supervivencia Global (SG)
    - Seguridad
    - Farmacocinética en un subgrupo de sujetos del grupo étnico con ascendencia asiática y de las islas del Pacífico
    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
    - SG: continuamente durante el ensayo y cada 8 semanas (+- 5 días) en el periodo de seguimiento
    - Seguridad: continuamente comenzando después de la firma del consentimiento informado, hasta 28 días después de la interrupción del tratamiento
    - Farmacocinética en un subgrupo de sujetos del grupo étnico con ascendencia asiática y de las islas del Pacífico: en cada día de FC antes de cada administración de la dosis y después a 0,25h, 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 3,5h, 4h, 6h, and 8h después de la dosis
    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 Information not present in EudraCT
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 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
    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.
    El final del estudio se define como la fecha de la última visita del último sujeto que complete el estudio o la fecha de recepción de los últimos datos del último sujeto que sean necesarios para los análisis principales, secundarios o exploratorios, según lo especificado de antemano en el protocolo o el plan de análisis estadístico, la que sea más tardía.
    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 months0
    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 state5
    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.
    De acuerdo al estándar de tratamiento que utilizaría el médico con ese paciente
    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 Decision2015-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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