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    Summary
    EudraCT Number:2014-004011-37
    Sponsor's Protocol Code Number:673-203
    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:2015-06-01
    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 number2014-004011-37
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label, Exploratory Biomarker Study of Talazoparib (BMN 673) Monotherapy in Patients with Recurrent or Metastatic Solid Tumors
    Estudio de Fase 2, multicéntrico, abierto y exploratorio de biomarcadores, con talazoparib (BMN 673) en monoterapia, en pacientes con tumores sólidos recurrentes o metastásicos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Open-Label, Exploratory Biomarker Study of Talazoparib (BMN 673) Monotherapy in Patients with Recurrent or Metastatic Solid Tumors
    Estudio de Fase 2, multicéntrico, abierto y exploratorio de biomarcadores, con talazoparib (BMN 673) en monoterapia, en pacientes con tumores sólidos recurrentes o metastásicos
    A.4.1Sponsor's protocol code number673-203
    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 SponsorBioMarin Pharmaceutical Inc.
    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 supportBioMarin Pharmaceutical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioMarin Pharmaceutical Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address105 Digital Drive
    B.5.3.2Town/ cityNovato
    B.5.3.3Post code94949
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@bmrn.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 nametalazoparib
    D.3.2Product code talazoparib (BMN 673)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nametalazoparib (BMN 673)
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 nametalazoparib
    D.3.2Product code talazoparib (BMN 673)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nametalazoparib (BMN 673)
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Recurrent or Metastatic Solid Tumors
    Tumores sólidos recurrentes o metastásicos
    E.1.1.1Medical condition in easily understood language
    Recurrent or Metastatic Solid Tumors
    Tumores sólidos recurrentes o metastásicos
    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 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    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 is to determine a potential association between HRD score and objective tumor response to talazoparib (BMN 673) treatment.
    El objetivo principal es determinar la posible asociación entre la puntuación de HRD y la respuesta objetiva del tumor al tratamiento con talazoparib (BMN 673).
    E.2.2Secondary objectives of the trial
    Secondary objectives include safety, PK, and preliminary talazoparib (BMN 673) efficacy.
    Los objetivos secundarios consisten en la seguridad, la farmacocinética y la eficacia preliminar del talazoparib (BMN 673)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 years of age or older
    - Histologically confirmed breast cancer or epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer)
    - Recurrent or metastatic disease for which talazoparib deemed an acceptable therapy by the investigator
    - No more than 4 prior chemotherapy regimens for metastatic disease (no limit on prior hormonal therapies)
    - Disease amenable to biopsy and willing to undergo mandatory biopsy at Screening and again at disease progression.
    - Have sufficient archival formalin-fixed paraffin-embedded (FFPE) resected primary ovarian tumor tissue or sufficient archival core breast tumor tissue (1 slide with 5-µm-thick sections and 9 slides with 10-µm-thick sections, minimum 20% tumor cellularity). [Note: Fresh core breast tumor tissue may be used if archival tissue is not available.]
    - Fresh tumor biopsy collected at Screening must be of sufficient quantity with minimum 25 mm2 surface area and 40 ?m thickness (eg, 2 mm x 15 mm core) and minimum two cores.
    - Measurable disease per RECIST 1.1
    - Eastern Cooperative Oncology Group (ECOG) performance status ?1
    - Adequate organ function as defined below:
    o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5x upper limit of normal (ULN) [Note: ?5xULN if liver function abnormalities are due to hepatic metastasis]
    o Total serum bilirubin ?1.5xULN [Note: ?3xULN for Gilbert's Syndrome]
    o Calculated creatinine clearance ?30 mL/min
    o Hemoglobin ?9.0 g/dL with last transfusion ?14 days before first study drug
    o Absolute neutrophil count (ANC) ?1500/mm3
    o Platelet count ?100,000/mm3
    - Able to take oral medications
    - Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study-related procedures
    - If sexually active, willing to use acceptable method of contraception (eg, double-barrier) during treatment and for 30 days after last dose of study drug
    - If females with childbearing potential, a negative serum pregnancy test at screening and willing to have additional serum and urine pregnancy tests during the study. [Note: Females without childbearing potential include those in menopause ?2 years, with tubal ligation ?1 year before screening, or with total hysterectomy.]
    - Willing and able to comply with all study procedures
    - Edad igual o superior a 18 años
    - Cáncer de mama o cáncer epitelial de ovario (lo que incluye el cáncer de trompa de Falopio y el cáncer peritoneal primario), con confirmación histológica
    - Enfermedad recurrente o metastásica para la que el investigador considera que el talazoparib es un tratamiento adecuado
    - No más de 4 regímenes de quimioterapia previos para enfermedad metastásica (sin límite en los tratamientos hormonales previos)
    - Enfermedad susceptible de biopsia y paciente con voluntad de someterse a la biopsia obligatoria en la Selección y, de nuevo, en la progresión de la enfermedad
    - Disponibilidad de suficiente tejido de archivo fijado con formol e incluido en parafina (FFIP) del tumor de ovario primario obtenido por resección o suficiente tejido de archivo del tumor de mama obtenido por biopsia con aguja gruesa (una preparación con cortes de 5 µm de grosor y 9 preparaciones con cortes de 10 µm de grosor, con un mínimo del 20% de celularidad tumoral). [Nota: Podrá utilizarse tejido tumoral mamario de una biopsia fresca con aguja gruesa si no se dispone de tejido de archivo.]
    - Biopsia tumoral fresca obtenida en la Selección, de suficiente cantidad, con un mínimo de 25 mm2 de superficie y 40 µm de grosor (por ejemplo, cilindro de 2 mm × 15 mm), y un mínimo de dos cilindros.
    - Enfermedad medible según los RECIST 1.1
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) ?1
    - Funcionalidad orgánica adecuada, definida por:
    o Aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) en suero ?2,5 × límite superior de la normalidad (LSN) [Nota: ?5 × LSN si las alteraciones funcionales hepáticas se deben a metástasis hepáticas]
    o Bilirrubina sérica total ?1,5 × LSN [Nota: ?3 × LSN en el síndrome de Gilbert]
    o Aclaramiento de creatinina calculado ?30 ml/min
    o Hemoglobina ?9,0 g/dl con la última transfusión ?14 días antes de la primera dosis del fármaco del estudio
    o Recuento absoluto de neutrófilos (RAN) ?1500/mm3
    o Plaquetas ?100.000/mm3
    - Capacidad de tomar medicación oral
    - Voluntad y capacidad de otorgar el consentimiento informado por escrito, firmado, después de que se haya explicado la naturaleza del estudio y antes de todo procedimiento relacionado con el estudio
    - En caso de actividad sexual, voluntad de utilizar un método anticonceptivo adecuado (por ejemplo, de doble barrera) durante el tratamiento y los 30 días siguientes a la última dosis del fármaco del estudio
    - En las mujeres potencialmente fértiles, prueba de embarazo en suero negativa en la Selección y voluntad de someterse a otras pruebas de embarazo en suero y orina durante el estudio [Nota: Son mujeres no potencialmente fértiles las posmenopáusicas desde hace ?2 años, las sometidas a ligadura de trompas ?1 año antes de la Selección y las intervenidas de histerectomía total.]
    - Voluntad y capacidad de cumplir todos los procedimientos del estudio.
    E.4Principal exclusion criteria
    ? Has deleterious or pathogenic germline BRCA1 or BRCA2 mutation
    ? If received prior platinum therapy, disease progression or recurrence within 6 months after last dose of platinum
    ? HER2-positive breast cancer or inflammatory breast cancer
    ? Has not recovered from acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion criteria
    ? Prior treatment with a PARP inhibitor
    ? History of central nervous system (CNS) metastasis (except adequately treated brain metastasis that is stable and does not require corticosteroids for management of CNS symptoms)
    ? Cytotoxic chemotherapy or anti-hormone therapy ?21 days before first day of study drug (?42 days if mitomycin C was the last chemotherapy) or radiotherapy ?21 days before first day of study drug
    ? Major surgery ?21 days before first day of study drug
    ? Any investigational product or investigational medical device ?28 days before first day of study drug
    ? Prior malignancy except for any of the following:
    o Carcinoma in situ of the cervix or non-melanoma skin cancer
    o A cancer diagnosed and definitively treated ?5 years previously with no evidence of recurrence
    ? Known to be human immunodeficiency virus (HIV) positive
    ? Known active replicating hepatitis C or B virus
    ? Myocardial infarction ?6 months before first day of study drug, symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
    ? Breast-feeding at screening or planning to become pregnant (self or partner) any time during study participation
    ? Concurrent disease or prior surgical procedure affecting talazoparib absorption
    ? Concurrent disease or condition that would interfere with study participation or safety, such as the following:
    o Active, clinically significant infection either Grade > 2 (NCI CTCAE v4.03) or requiring parenteral antimicrobial agents ?14 days before first day of study drug
    o Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
    o Non-healing wound, ulcer, or bone fracture
    o Bone marrow disorders, including myelodysplasia
    ? Known hypersensitivity to any talazoparib component
    ? Presencia de mutación nociva o patógena de BRCA1 o BRCA2 en la línea germinal
    ? En caso de tratamiento previo con platino, progresión o recidiva de la enfermedad en el plazo de los 6 meses siguientes a la última dosis de platino
    ? Cáncer de mama positivo para HER2 o carcinoma inflamatorio de mama
    ? No se ha recuperado de los efectos tóxicos agudos del tratamiento anterior, excepto la alopecia relacionada con el tratamiento o las alteraciones analíticas de laboratorio que por lo demás cumplan los criterios de inclusión
    ? Tratamiento previo con un inhibidor de la PARP
    ? Antecedentes de metástasis en el sistema nervioso central (SNC) (excepto las metástasis cerebrales adecuadamente tratadas que permanezcan estables y no precisen corticosteroides para el control de los síntomas del SNC)
    ? Quimioterapia citotóxica o tratamiento antihormonal ?21 días antes del primer día del fármaco del estudio (?42 días si el último quimioterápico fuera mitomicina C) o radioterapia ?21 días antes del primer día del fármaco del estudio
    ? Cirugía mayor ?21 días antes del primer día del fármaco del estudio
    ? Medicamento o producto sanitario en investigación ?28 días antes del primer día del fármaco del estudio
    ? Neoplasia maligna a previa, excepto lo siguiente:
    o Carcinoma in situ del cuello uterino o cáncer cutáneo no melanómico
    o Cáncer diagnosticado y tratado definitivamente ?5 años antes sin signos de recidiva
    ? Positividad conocida para el virus de la inmunodeficiencia humana (VIH)
    ? Replicación activa conocida del virus de la hepatitis C o B
    ? Infarto de miocardio ?6 meses antes del primer día del fármaco del estudio, insuficiencia cardiaca congestiva sintomática (clase de la New York Heart Association >II), angina inestable o arritmia cardiaca inestable que requiera medicación
    ? En periodo de lactancia en la Selección o intención de quedarse embarazada (la paciente o la pareja del paciente) en cualquier momento durante la participación en el estudio
    ? Enfermedad concomitante o intervención quirúrgica previa que altere la absorción del talazoparib
    ? Proceso o enfermedad concomitante que pudiera interferir en la participación en el estudio o en la seguridad, como lo siguiente:
    o Infección activa clínicamente importante de grado >2 (NCI CTCAE v4.03) o bien que requiera tratamiento antibiótico parenteral ?14 días antes del primer día del fármaco del estudio
    o Diátesis hemorrágica o coagulopatía clínicamente importante, lo que incluye trastornos conocidos de la función plaquetaria
    o Herida, úlcera o fractura ósea que no cicatriza/consolida
    o Trastornos de la médula ósea, incluida la mielodisplasia
    ? Hipersensibilidad conocida a cualquier componente del talazoparib
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) according to revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with breast cancer and ovarian cancer.
    Tasa de respuesta Objetiva (TRO) según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1) en pacientes con cáncer de mama o cáncer de ovario .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Anticipated in about 24-30 months following first patient enrolled
    Previsto en unos 24 a 30 meses después de la inclusión del primer paciente
    E.5.2Secondary end point(s)
    Progression-free survival (PFS), Duration of response (DOR) for objective responders, and Gynecologic Cancer InterGroup (GCIG) CA125 response in patients with ovarian cancer
    Supervivencia sin progresión (SSP), duración de la respuesta (DDR) en los sujetos con respuesta objetiva y respuesta del CA125 según el Gynecologic Cancer InterGroup (GCIG) en las pacientes con cáncer de ovario .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Anticipated in about 24-30 months following first patient enrolled
    Previsto en unos 24 a 30 meses después de la inclusión del primer paciente
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Austria
    Belgium
    Denmark
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    Singapore
    Spain
    Taiwan
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    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)
    Expected normal treatment of condition
    El tratamiento normal esperado por su condición
    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 Decision2015-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
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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
    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.

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