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    Summary
    EudraCT Number:2015-003582-28
    Sponsor's Protocol Code Number:LOXO-TRK-15002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-003582-28
    A.3Full title of the trial
    A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors
    Estudio basket de fase II del inhibidor oral de la actividad TRK LOXO-101
    en pacientes con tumores portadores de genes de fusión NTRK
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors
    Estudio basket de fase II del inhibidor oral de la actividad TRK LOXO-101
    en pacientes con tumores portadores de genes de fusión NTRK
    A.4.1Sponsor's protocol code numberLOXO-TRK-15002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02576431
    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 SponsorLoxo Oncology 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 supportLoxo Oncology Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointCountry Manager - Monica Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressC/ Jorge Juan, S/N. Portal 54, Pl.2ª, Puerta Izq.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28001
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918534105
    B.5.5Fax number+34900981853
    B.5.6E-mailSpain.Regulatory@medpace.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 nameLOXO-101
    D.3.2Product code LOXO-101
    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 INNLOXO-101
    D.3.9.2Current sponsor codeLOXO-101
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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
    Solid Tumors
    tumores portadores de genes de fusión
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term 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
    To determine the overall response rate (ORR) as measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate, following treatment with LOXO-101 in adult subjects with an advanced cancer harboring a fusion involving NTRK1, NTRK2, or NTRK3 (collective referred to as NTRK fusions) for each tumor-specific disease cohort
    Determinar la tasa de respuesta global (TRG) medida mediante el
    porcentaje de pacientes con mejor respuesta global confirmada de
    respuesta completa (RC) o respuesta parcial (RP) según los criterios de
    evaluación de la respuesta en tumores sólidos (Response Evaluation
    Criteria in Solid Tumors), versión 1.1 (RECIST 1.1) o los criterios de
    evaluación de la respuesta en neurooncología (Response Assessment in
    Neuro-Oncology, RANO), según el caso, después del tratamiento con
    LOXO-101 en adultos con cáncer avanzado que fueran portadores de un
    gen de fusión con NTRK1, NTRK2 o NTRK3 (colectivamente denominados
    genes de fusión NTRK) para cada cohorte de tipo tumoral específico.
    E.2.2Secondary objectives of the trial
    ? To evaluate the duration of response (DOR) in subjects with best overall response of CR or PR.
    ? To estimate the proportion of subjects that has any tumor regression as a best response.
    ?To evaluate the duration of progression-free survival (PFS) following initiation of LOXO-101.
    ? To evaluate the duration of overall survival (OS) following initiation of LOXO-101.
    ? To assess the safety profile and tolerability of LOXO-101.
    ? To compare the duration of PFS following initiation of LOXO-101 to that following the line of therapy immediately preceding LOXO-101 in subjects who have received prior therapy.
    ? To evaluate the clinical benefit rate (CBR) based on the proportion of subjects with best overall response of CR, PR, or stable disease lasting 16 or more weeks following initiation of LOXO-101.
    ? To evaluate the concordance of prior molecular profiling that detected an NTRK fusion within the subject?s tumor with the diagnostic test being evaluated by the Sponsor
    ?Evaluar la duración de la respuesta (DR) en pacientes con RC o RP como mejor respuesta global.
    ?Estimar el porcentaje de pacientes con cualquier tipo de regresión del tumor como mejor respuesta.
    ?Evaluar la duración de la supervivencia sin progresión (SSP) después
    del inicio de la administración de LOXO-101.
    ?Evaluar la duración de la supervivencia global (SG) después del inicio
    de la administración de LOXO-101.
    ?Evaluar el perfil de seguridad y la tolerabilidad de LOXO-101.
    ?Comparar la duración de la SSP después del inicio de la administración
    de LOXO-101 con la observada después de la línea de tratamiento
    inmediatamente anterior a LOXO-101 en pacientes que hayan recibido
    tratamiento previo.
    ?Evaluar la tasa de beneficio clínico (TBC) basada en el porcentaje de
    pacientes que tuvieron como mejor respuesta global RC, RP o
    enfermedad estable durante 16 semanas.
    ?Evaluar la concordancia del perfil molecular previo que detectó un gen de fusión NTRK en el tumor del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
    2. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
    3. Subjects must have at least one measurable lesion as defined by RECIST 1.1 (Eisenhauer 2009). Subjects without RECIST measurable disease (e.g., evaluable disease only) will be eligible for enrollment to Cohort 8, regardless of tumor type. Subjects in Cohort 7 (primary CNS tumors) should meet the following criteria:
    a. Have received prior treatment including radiation and/or chemotherapy, with radiation completed > 12 weeks prior to C1D1 of therapy, as recommended or appropriate for that CNS tumor type.
    b. Have ? 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging [MRI] and evaluable by RANO criteria), with the size of at least one of the measurable lesions ? 1 cm in each dimension and noted on more than one imaging slice.
    c. Imaging study performed within 28 days before enrollment while on stable dose steroid medication for at least 5 days immediately before and during the imaging study.
    4. At least 18 years of age.
    5. Eastern Cooperative Oncology Group (ECOG) score of ? 2.
    6. Archived tumor tissue. If archival tissue is known to not be available then an on-study tumor biopsy should be attempted if it can be safely performed.
    7. Adequate organ function as defined by the following criteria:
    a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 × upper limit of normal (ULN), or AST and ALT < 5 × ULN if liver function abnormalities are due to underlying malignancy.
    b. Total bilirubin < 2.5 × ULN, except in the setting of biliary obstruction. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
    c. Serum creatinine < 2.0 × ULN OR an estimated glomerular filtration rate ? 30 mL/minute using the Cockroft-Gault formula:
    (140 ? age) x body weight (kg) × 0.85 (if female)
    serum creatinine (mg/dL) × 72
    8. Ability to swallow capsules, comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
    9. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion.
    1. Neoplasia maligna localmente avanzada o metastásica con un gen de
    fusión NTRK3, identificado mediante ensayos moleculares como los
    realizados habitualmente en laboratorios certificados conforme las CLIA
    u otros laboratorios con certificación similar.
    2. Los pacientes deben haber recibido tratamiento de referencia previo
    apropiado para su tipo tumoral y estadio de la enfermedad o, según la
    opinión del investigador, sería improbable que tolerasen u obtuviesen un
    efecto clínico beneficioso del tratamiento de referencia correspondiente.
    3. Los pacientes deben presentar como mínimo una lesión mensurable
    según la definición de los criterios RECIST 1.1 (Eisenhauer, 2009). Los
    pacientes sin enfermedad mensurable según los criterios RECIST (p. ej.,
    enfermedad evaluable únicamente) serán elegibles para su inclusión en
    la cohorte 8, con independencia del tipo de tumor. Los pacientes de la
    cohorte 7 (tumores primarios del SNC) deben cumplir los criterios
    siguientes:
    a. Haber recibido tratamiento previo, incluida radioterapia,
    quimioterapia o ambas, habiéndose completado la radioterapia > 12
    semanas antes del D1C1 del tratamiento, según se recomiende o sea
    adecuado para ese tipo de tumor del SNC.
    b. Presentar ? 1 localización de enfermedad mensurable
    bidimensionalmente (confirmada mediante resonancia magnética
    nuclear [RMN] y evaluable mediante los criterios RANO), siendo el
    tamaño de al menos una de las lesiones mensurables ? 1 cm en cada
    dimensión y visible en más de un corte.
    c. Estudio de imagen realizado en los 28 días previos a la inclusión
    mientras el paciente estaba recibiendo una dosis estable de
    corticosteroides durante un mínimo de 5 días inmediatamente antes y
    durante el estudio de imagen.
    4. Tener al menos 18 años.
    5. Puntuación ? 2 en el estado funcional del Eastern Cooperative
    Oncology Group (véase el Anexo A).
    6. Tejido tumoral de archivo. Si se sabe que no se dispone de tejido
    tumoral de archivo, deberá tratar de hacerse una biopsia del tumor
    durante el estudio si es seguro realizarla.
    7. Función orgánica aceptable, definida por los siguientes criterios:
    a. Concentraciones séricas de aspartato-aminotransferasa (ASAT) y
    alanina-aminotransferasa (ALAT) < 2,5 veces el límite superior de la
    normalidad (LSN) o ASAT y ALAT < 5 ? LSN en el caso de que existan
    alteraciones de la función hepática como consecuencia de una neoplasia
    maligna subyacente.
    b. Bilirrubina total < 2,5 × LSN, salvo en caso de obstrucción biliar. Los
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    pacientes con antecedentes de enfermedad de Gilbert y una elevación
    aislada de los niveles de bilirrubina indirecta son aptos para participar
    en el estudio.
    c. Creatinina sérica < 2,0 ? LSN O una filtración glomerular estimada ?
    30 ml/minuto según la fórmula de Cockroft-Gault:
    (140 ? edad) peso corporal (kg) ? 0,85 (en mujeres)
    creatinina sérica (mg/dl) × 72
    8. Capacidad para tragar cápsulas y cumplir con el tratamiento
    ambulatorio, la monitorización analítica y las visitas clínicas obligatorias
    mientras dure la participación en el estudio.
    9. Disposición de los varones y las mujeres que pueden quedarse
    embarazadas para utilizar métodos anticonceptivos eficaces habituales
    durante la administración del tratamiento y los 3 meses posteriores a
    que se complete el estudio.
    E.4Principal exclusion criteria
    1. Investigational agent or anticancer therapy within 2 weeks prior to planned start of LOXO-101 or 5 half-lives, whichever is shorter, and with recovery of clinically significant toxicities from that therapy.
    Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study). Subjects with primary CNS tumors are eligible.
    3. Uncontrolled concurrent malignancy that would limit assessment of efficacy of LOXO-101.
    4. Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease or other systemic disease that would limit compliance with study procedures.
    5. Malabsorption syndrome or other condition affecting oral absorption.
    6. Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation.
    7. Pregnancy or lactation.
    1. Haber recibido un fármaco en investigación o tratamiento
    antineoplásico en las 2 semanas anteriores al inicio previsto del
    tratamiento con LOXO-101 o 5 semividas, el periodo que sea más corto,
    y haberse recuperado de las toxicidades clínicamente significativas de
    ese tratamiento.
    2. Metástasis cerebrales sintomáticas o inestables. (Atención: Los
    pacientes con metástasis cerebrales asintomáticas serán elegibles para
    participar en el estudio.) Los pacientes con tumores primarios del SNC
    podrán participar en el estudio.
    3. Neoplasia maligna simultánea no controlada que limitaría la
    evaluación de la eficacia de LOXO-101.
    4. Infección bacteriana, vírica o fúngica sistémica activa no controlada,
    enfermedad cardiovascular inestable u otra enfermedad sistémica que
    limitaría el cumplimiento de los procedimientos del estudio.
    5. Síndrome de malabsorción u otro proceso patológico que afecte a la
    absorción oral.
    6. Imposibilidad de interrumpir el tratamiento con un inhibidor o un
    inductor potente de la isoenzima CYP3A4 (véase el Anexo B) antes del
    inicio del tratamiento.
    7. Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response of confirmed CR or PR as measured by RECIST 1.1 or RANO criteria, as appropriate to tumor type.
    ? RC o RP confirmadas como mejor respuesta global, medidas mediante
    los criterios RECIST 1.1 o RANO, según el tipo de tumor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 2-3 months from baseline until disease progression
    cada 2 - 3 meses desde la visita de inicio hasta que se documente la
    progresión.
    E.5.2Secondary end point(s)
    ? DOR: determined for subjects with best overall response of confirmed CR or PR
    ? CBR: best overall response of confirmed CR, PR, or stable disease lasting 16 or more weeks following the initiation of LOXO-101.
    ? PFS: number of months from initiation of LOXO 101 to the earlier of disease progression or death due to any cause.
    ? OS: number of months from the initiation of LOXO 101 to the date of death due to any cause.
    ? Comparison of PFS following initiation of LOXO 101 to that following the line of therapy immediately preceding LOXO 101 in each subject who has received prior therapy.
    ? Incidence, severity, and duration of adverse events, including all, serious, and those considered treatment-related.
    ? Changes from baseline in clinical safety laboratory values and vital signs.
    ? DR: determinada en los pacientes con RC o RP confirmada como
    mejor respuesta global; la DR se define como el número de meses desde
    el inicio de la RC o de la RP (la que se registre en primer lugar) y su
    posterior confirmación hasta que se documente la primera fecha de
    recidiva o progresión de la enfermedad o el fallecimiento.
    ? TBC: mejor respuesta global de RC, RP o enfermedad estable durante
    16 semanas o más después del inicio del tratamiento con LOXO-101.
    ? SSP: número de meses desde el inicio del tratamiento con LOXO-101
    hasta que se produzca progresión de la enfermedad o muerte por
    cualquier causa (lo que ocurra primero).
    ? SG: número de meses desde el inicio del tratamiento con LOXO-101
    hasta la fecha de la muerte por cualquier causa.
    ? Comparación de la SSP después del inicio de la administración de
    LOXO-101 con la observada después de la línea de tratamiento
    inmediatamente anterior a LOXO-101 en pacientes que hayan recibido
    tratamiento previo.
    ? Incidencia, intensidad y duración de los AA, incluidos todos ellos, los
    graves y los considerados relacionados con el tratamiento.
    ? Variaciones respecto al periodo basal en los valores analíticos de
    seguridad y en las constantes vitales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 2-3 months from baseline until disease progression or toxicity onset or death
    cada 2 - 3 meses desde la visita de inicio hasta que se documente la
    progresión o aparicion de toxicidad o la muerte.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Basket design
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    European Union
    Korea, Republic of
    Singapore
    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
    LVLS
    Ultima visita del ultimo 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 months1
    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
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 151
    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)
    None
    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 Decision2016-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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