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    Summary
    EudraCT Number:2011-004418-40
    Sponsor's Protocol Code Number:H9H-MC-JBAL
    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:2012-01-19
    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 number2011-004418-40
    A.3Full title of the trial
    A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma
    Estudio en fase 2 de LY2157299 monohidrato en monoterapia o LY2157299 monohidrato más lomustina en comparación con lomustina en monoterapia en pacientes con glioblastoma recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Recurrent Glioblastoma
    Estudio en pacientes con glioblastoma recurrente
    A.4.1Sponsor's protocol code numberH9H-MC-JBAL
    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 SponsorLilly S.A,
    B.1.3.4CountrySpain
    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 supportLilly S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria 30
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916633485
    B.5.5Fax number34916633481
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2157299 monohydrate
    D.3.2Product code LY2157299 monohydrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeLY2157299 Monohydrate
    D.3.9.3Other descriptive nameTGF-B inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameLomustine
    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 INNLOMUSTINE
    D.3.9.1CAS number 13010-47-4
    D.3.9.4EV Substance CodeSUB08567MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number130
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma
    Glioblastoma
    E.1.1.1Medical condition in easily understood language
    Brain cancer
    Cancer en cerebro
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall Survival
    El objetivo principal de este estudio consiste en comparar las distribuciones de la supervivencia global (SG) entre LY2157299 monohidrato más lomustina y lomustina más placebo (grupo de control) en pacientes que presentan un GB recidivante o progresivo después de un tratamiento de primera línea con quimiorradioterapia
    E.2.2Secondary objectives of the trial
    PK of LY2157299 monohydrate.
    Evaluate Safety
    Prognostic and predictive marker assessment
    Progression-free survival , median OS and PFS, OS and PFS rates at 6 months
    Tumor response rate
    Assess patient-reported symptoms and neurocognitive function
    Farmacocinética de LY.
    Seguridad de LY solo y más lomustina; y con respecto a lomustina+PCB.
    Farmacodinamia: marcadores pronósticos y predictivos:
    o Biomarcadores en tejido tumoral asociados al crecimiento tumoral y la vía de señalización de TGF-beta y asociación con las respuestas clínicas (RC).
    o Marcadores tumorales en suero/plasma y proteínas secretadas y asociación con las RC.
    o Respuestas de biomarcadores de linfocitos T y asociación con las RC.
    Eficacia:
    o SG y razón de riesgos instantáneos (RRI) entre lomustina+más PCB y LY solo; y entre LY+lomustina y LY solo.
    o Distribuciones de supervivencia sin progresión (SSP) y otros parámetros a partir de las distribuciones de SG y SSP en cada grupo de tratamiento.
    o Tasa de respuesta tumoral (criterios RANO) en cada grupo de tratamiento.
    Resultados de salud: Síntomas comunicados por los pacientes mediante MDASI-BT, y función neurocognitiva mediante HVLT-R, la prueba de trazado (A y B), y la COWA en cada grupo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients at or older than 18 years and who have relapsed Glioblastoma after first-line treatment with chemoradiation, have measureable disease (response to be based on RANO criteria), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    [1] Diagnóstico confirmado histológicamente de GB intracraneal recidivante (grado IV de la OMS, incluidos gliosarcomas). Los pacientes con GB secundarios también podrán participar. La muestra tumoral diagnóstica original deberá estar disponible para un examen anatomopatológico centralizado.
    [2] Pacientes con progresión tumoral según criterios RANO tras una quimiorradioterapia habitual.
    [3] Pacientes con una resección quirúrgica previa serán elegibles en los siguientes casos:
    ? Tienen que haberse recuperado de los efectos de la cirugía.
    ? Tiene que existir enfermedad evaluable o medible (criterios RANO).
    [4] Disponer de tejido tumoral para evaluación de biomarcadores pronósticos y predictivos adicionales.
    [5] Estado funcional (EF) de 0 o 1 según ECOG.
    [6] Suspensión de todos los tratamientos previos contra el cáncer, salvo paliativos, y recuperación de los efectos agudos del tratamiento.
    [7] Función orgánica suficiente:
    ? Reserva medular: recuento absoluto de neutrófilos (RAN) ?1,5?109/l, recuento de plaquetas ?100?109/l y hemoglobina ?9 g/dl.
    ? Hepática: bilirrubina total ?2,0 veces LSN, fosfatasa alcalina (FA), aspartato transaminasa (AST/SGOT) y alanina transaminasa (ALT) ?? veces el LSN.
    ? Renal: creatinina sérica <1,5 veces el LSN.
    [8] Varones o mujeres con mas de 18 años.
    [8a] Los varones deben comprometerse a usar un método anticonceptivo fiable durante el estudio y durante al menos 12 semanas después de la última dosis de medicamento.
    [8b] Las mujeres deben ser mujeres posmenopáusicas o si están en edad fértil, deben dar negativo en una prueba de embarazo en el momento de inclusión y comprometerse a usar un método anticonceptivo fiable durante el estudio y durante 3 meses después de la última dosis del producto
    [9] Otorgar el consentimiento informado por escrito antes de realizar procedimientos específicos del estudio.
    [10] Ser capaz de deglutir cápsulas (lomustina) y comprimidos (LY2157299/placebo).
    E.4Principal exclusion criteria
    Moderate or severe cardiac condition. Prior treatment with nitrosurea. Prior treatment with bevacizumab as part of a first-line treatment for GB, Serious concomitant systemic disorder, Current acute or chronic myelogenous leukemia, Second primary malignancy, Pregnant or breast-feeding women
    [11] Estar incluido en la actualidad en un ensayo clínico, o haberse retirado del mismo en los 30 días anteriores, sobre un producto en investigación (incluidos inhibidores del receptor del factor de crecimiento del endotelio vascular [VEGFR]) o sobre el uso no autorizado de un medicamento o dispositivo (distinto del medicamento o dispositivo utilizado en este estudio) o estar incluido de forma simultánea en algún otro tipo de investigación médica que no se considere científica o médicamente compatible con este estudio.
    [12] Haber finalizado ya o haberse retirado de este estudio o de cualquier otro estudio en que se investigue el uso de LY2157299.
    [13] Padecer una cardiopatía moderada o grave:
    a) Presencia de una cardiopatía, entre ellas, infarto de miocardio durante los 6 meses anteriores a la incorporación al estudio, angina de pecho inestable, insuficiencia cardíaca congestiva de clase III y IV según la New York Heart Association (NYHA) o hipertensión arterial no controlada.
    b) Presencia de anomalías electrocardiográficas (ECG) importantes y documentadas que no estén controladas con tratamientos médicos (por ejemplo, arritmias auriculares o ventriculares sintomáticas o mantenidas, bloqueo auriculoventricular de segundo o tercer grado, bloqueos de rama, hipertrofia ventricular o infarto de miocardio reciente).
    c) Presencia de anomalías importantes documentadas mediante un ecocardiograma con Doppler (por ejemplo, defecto moderado o intenso de la función valvular o fracción de eyección del ventrículo izquierdo (FEVI) < 50%; evaluación con arreglo al límite inferior de la normalidad en cada centro). Para obtener más detalles, consúltese el protocolo de realización de ecocardiogramas (Anexo 6).
    d) Padecer enfermedades que predisponen al desarrollo de aneurismas de la aorta ascendente o que causan estrés en la aorta (por ejemplo, antecedentes familiares de aneurismas, síndrome de Marfan, válvula aórtica bicúspide o datos de lesión de los grandes vasos del corazón documentada mediante tomografía computarizada [TC] con contraste).
    [14] Haber recibido un tratamiento previo con nitrosoureas (incluidos lomustina y Gliadel®/carmustina local).
    [15] Haber recibido bevacizumab con anterioridad como parte de un tratamiento de primera línea contra el GB (cuando el tratamiento haya finalizado 12 meses antes de la inclusión, el paciente podrá participar en el ensayo).
    [16] Padecer un trastorno sistémico concomitante grave (por ejemplo, infección activa, como la debida al virus de la inmunodeficiencia humana [VIH]), que, en opinión del investigador, podría comprometer la capacidad del paciente de observar el protocolo.
    [17] Presentar una leucemia mielógena aguda o crónica activa.
    [18] Padecer una segunda neoplasia maligna primaria que, a criterio del investigador y del promotor, podría influir en la interpretación de los resultados (por ejemplo, tumores de progresión lenta que en los 3 años precedentes hayan presentado un crecimiento acelerado y sean resistentes a otros tratamientos; en el caso de los pacientes con cánceres de mama y próstata, véase el criterio de inclusión [6]).
    [19] Estar embarazada o en período de lactancia.
    [20] No mostrarse dispuesto o ser incapaz de participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of randomization to the date of death from any cause
    Desde la randomizacion hasta la muerte del paciente por cualquier razon
    E.5.2Secondary end point(s)
    Progression-free survival and PFS rate at 6 months, 9 months, 12 months
    Median OS and at 6 months
    Tumor response rate
    PK of LY2157299 monohydrate.
    Evaluate Safety
    Prognostic and predictive marker assessment
    Tumor response rate RANO criteria
    Change in patient-reported symptoms and neurocognitive function
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS - Every 2 cycles (8 weeks) from start of treatment until documented disease progression or death from any cause.
    RR - Baseline to disease progression
    PK ? Cycle 1 ( Day,1,3,14,15,16)
    Safety ? Every Cycle until study discontinuation
    Patient-reported symptoms and neurocognitive function - Every 2 cycles (8 weeks) from baseline until study discontinuation
    Prognostic and predictive marker assessment Cycle 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Australia
    Canada
    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
    Last visit of the last subject
    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 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
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 180
    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)
    Patients who have discontinued study treatment without progression will continue to be followed for progression or until they start a new anticancer therapy. All patients will be followed until death.
    Los pacientes que interrumpan el tratamiento del estudio sin progresión continuarán su seguimiento hasta la progresión o hasta que empiecen una nueva terapia contra el cáncer. Todos los pacientes serán seguidos hasta su muerte.
    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 Decision2012-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
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