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    Summary
    EudraCT Number:2012-002571-34
    Sponsor's Protocol Code Number:CBKM120F2303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-02
    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 number2012-002571-34
    A.3Full title of the trial
    A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatmen
    ?Estudio fase III, aleatorizado, doble ciego, controlado con placebo de BKM120 con fulvestrant, en mujeres postmenopáusicas con cáncer de mama metastásico o localmente avanzado con receptores hormonales positivos HER2 negativo, tratadas con IA, que han progresado durante o después del tratamiento con un inhibidor de mTOR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III study of BKM120 with fulvestrant in patients with HR+,HER2-, AI treated, locally advanced or metastatic breast cancer who progressed on or after mTORi
    Estudio fase III de BKM120 con fulvestrant en pacientes con receptor hormonal +, HER2-, tratadas con IA, con cáncer de mama localmente avanzado o metastásico que han progresado durante o después del tratamiento con un inhibidor de mTOR
    A.3.2Name or abbreviated title of the trial where available
    BELLE 3
    BELLE 3
    A.4.1Sponsor's protocol code numberCBKM120F2303
    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 SponsorNovartis Farmacéutica 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34933064464NA
    B.5.5Fax number+34933064290NA
    B.5.6E-maileecc.novartis@novartis.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 nameBKM120
    D.3.2Product code BKM120
    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 INNnot established
    D.3.9.1CAS number not known
    D.3.9.2Current sponsor codeBKM120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameBKM120
    D.3.2Product code BKM120
    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 INNnot established
    D.3.9.1CAS number not known
    D.3.9.2Current sponsor codeBKM120
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Faslodex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namefulvestrant
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFULVESTRANT
    D.3.9.1CAS number 129453-61-8
    D.3.9.2Current sponsor codefulvestrant
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboCapsule, hard
    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
    This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive HER2 negative locally advanced or metastatic breast cancer who progressed on or after mTORi.
    El estudio quiere determinar si el tratamiento con BKM120 más fulvestrant es efectivo y seguro en el tratamiento en mujeres postmenopáusicas con cáncer de mama metastásico o localmente avanzado, con HR+ HER2-, que han progresado durante o después del tratamiento con un régimen que contenía mTORi.
    E.1.1.1Medical condition in easily understood language
    addition of BKM120 to fulvestrant for treatment of patients with hormone receptor-positive HER2 negative locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitors.
    Adición de BKM120 a Fulvestrant en el tratamiento de mujeres con cáncer de mama metastásico o localmente avanzado con receptores HR+, HER2- que han progresado durante el tratamiento con inhibidor MTOR
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full population).

    To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant, for the PI3K pathway activated sub-population.
    - Determinar si el tratamiento con BKM120 más fulvestrant prolonga la SLP en base a la evaluación local del investigador comparado con el tratamiento con placebo más fulvestrant para todas las pacientes, independientemente del estado de activación de la vía de señalización PI3K (población completa) y para la subpoblación con la vía de señalización PI3K activada
    Objetivos secundarios coprincipales:
    - Determinar si el tratamiento con BKM120 más fulvestrant prolonga la supervivencia global (SG) comparado con el tratamiento con placebo más fulvestrant para todas las pacientes, independientemente del estado de activación de la vía de señalización PI3K (población completa) y para la subpoblación con la vía de señalización PI3K activada
    E.2.2Secondary objectives of the trial
    Overall survival (OS)
    Overall response rate (ORR)
    Clinical benefit rate (CBR)
    Type, frequency and severity of adverse events
    Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK)
    Patient reported outcome for global health status/QoL
    Evaluar:
    - La SLP en la subpoblación con la vía de señalización PI3K no activada/desconocida .
    - La SG en la subpoblación con la vía de señalización PI3K no activada/desconocida .
    - La tasa de respuesta global en la población completa, subpoblación con la vía de señalización PI3K activada y en la subpoblación con la vía de señalización PI3K no activada/desconocida .
    -La tasa de beneficio clínico en la población completa, subpoblación con la vía de señalización PI3K activada y en la subpoblación con la vía de señalización PI3K no activada/desconocida .
    - Seguridad y tolerabilidad en la población completa
    - Farmacocinética de BKM120 administrado en combinación con fulvestrant en esta población de pacientes
    - Calidad de vida relacionada con la salud de las pacientes (HRQoL) en la población completa y en la subpoblación con la vía de señalización PI3K activada
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Postmenopausal women breast cancer that is locally advanced or metastatic HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
    A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization prior treatment with AIs
    Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
    Adequate bone marrow and organ function
    Other protocol defined criteria may apply
    ? Pacientes con evidencia radiológica de cáncer de mama metastásico o localmente avanzado inoperable
    ? Pacientes de las que se disponga de tejido de tumor archivado para el análisis de biomarcadores relacionados con PI3K
    ? Pacientes con estado de activación de la vía de señalización PI3K definido por un laboratorio designado por Novartis como activado, no activado o desconocido antes de la aleatorización siempre que la muestra archivada de la paciente contenga una cantidad suficiente de tejido de tumor
    ? Pacientes con cáncer de mama con receptor progesterónico positivo y/o receptor estrogénico positivo y HER2- determinado por análisis del laboratorio local
    ? Las pacientes deberán haber recibido tratamiento previo con IAs en el marco neo/adyuvante o metastásico/localmente avanzado. Las pacientes pueden haber recibido cualquier número de líneas de terapias endocrinas/hormonales antes del inicio del estudio.
    ? Pacientes con evidencia objetiva o radiológica de progresión con la combinación de terapia endocrina y mTORi administrada como la última terapia antes del inicio del estudio. La progresión deberá haber ocurrido durante, o dentro de los 30 días del final del régimen de tratamiento. Las pacientes a las que se les retire uno de los dos agentes por motivos de seguridad, aún serán elegibles en el momento de la progresión de la enfermedad para el agente en monoterapia (terapia endocrina o mTORi).
    ? Las pacientes deberán presentar lesiones óseas líticas o mixtas (líticas + blásticas) no medibles o enfermedad medible según los RECIST 1.1
    ? Pacientes con estado funcional del Grupo de Oncología Cooperativo del Este (ECOG) ? 2 que el investigador considere estable en el momento de la selección
    E.4Principal exclusion criteria
    More than 1 prior chemotherapy given for locally advanced or metastatic disease
    Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
    Symptomatic CNS metastases
    Concurrent malignancy or malignancy within 3 years prior to start of study treatment
    Certain drugs or radiation within 2-4 weeks of enrollment - Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
    Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
    Hypersensitivity to fulvestrant excipients
    Certain scores on an anxiety and depression mood questionnaire given at screening
    Other protocol defined criteria may apply
    ? Pacientes que hayan recibido tratamiento previo con inhibidores de PI3K, inhibidores de AKT o fulvestrant
    ? Pacientes que hayan recibido más de una línea de quimioterapia para la enfermedad metastásica
    ? Pacientes con metástasis sintomáticas del SNC
    ? Pacientes que estén recibiendo actualmente tratamiento crónico (> 5 días) o con dosis crecientes con corticosteroides u otro agente inmunosupresor, como administración crónica de corticosteroides (> 5 días) que puedan inducir CYP3A4
    ? Pacientes con una puntuación ? 12 en el cuestionario PHQ-9.
    ? Pacientes que seleccionen las respuestas de ?1, 2 ó 3? a la pregunta 9 en el cuestionario PHQ-9 respecto al potencial de pensamientos o ideación de suicidio
    ? Pacientes con una puntuación en la escala de ánimo GAD-7 ? 15.
    ? Pacientes con antecedentes clínicamente documentados de o episodio depresivo mayor activo, trastorno bipolar (I o II), trastorno obsesivo-compulsivo, esquizofrenia, un antecedente de intento o ideación de suicidio o ideación de homicidio (por ejemplo, riesgo de dañar a los demás o a él/ella mismo/a).
    ? Pacientes con ansiedad ? grado 3 de los CTCAE
    ? Pacientes con enfermedad cardiaca activa o antecedentes de disfunción cardíaca
    E.5 End points
    E.5.1Primary end point(s)
    PFS in the full population and PI3K pathway activated sub-population based on local investigator assessment.
    SLP en la población completa y en la subpoblación con la vía de señalización PI3K activada, basado en la evaluación local
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approx. 5.5 months
    Aproximadamente 5.5 meses
    E.5.2Secondary end point(s)
    OS in the full population and PI3K pathway activated sub-population.
    PFS in the PI3K pathway non-activated/unknown subpopulation* based on local investigator assessment
    OS in the PI3K pathway non-activated/unknown subpopulation
    ORR in the full population, PI3K pathway activated subpopulation and in the PI3K pathway non-activated/unknown sub-population
    Clinical benefit rate in the full population, PI3K pathway activated subpopulation and in the PI3K pathway non activated/unknown sub-population
    Type, frequency and severity of laboratory toxicities per CTCAEv4.03
    Plasma concentration-time profiles of BKM120 given in combination with fulvestrant and appropriate individual PK parameters based on population PK model
    Time to definitive 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30
    Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30
    SG en la población completa y en la subpoblación con la vía de señalización PI3K activada.
    SLP en la subpoblación con la vía de señalización PI3K no activada/desconocida* basado en la evaluación del investigador local.
    SG en la subpoblacióncon la vía de señalización PI3K no activada/desconocida.
    TRG en la población completa, en la subpoblación con la vía de señalización PI3K activada y en la subpoblación con la vía de señalización PI3K no activada/desconocida*

    Tasa de beneficio clínico en la población completa, en la subpoblación con la vía de señalización PI3K activada y en la subpoblación con la vía de señalización PI3K no activada/desconocida
    Tipo, frecuencia e intensidad de las toxicidades de laboratorio según los CTCAEv4.03
    Perfiles de tiempo-concentración plasmática de BKM120 administrado en combinación con fulvestrant y parámetros PK individuales apropiados basados en el modelo PK de población
    Tiempo hasta el deterioro definitivo del 10% en el estado de salud global/puntuación de la escala de QOL del QLQ-C30 de la EORTC
    Cambio, respecto a la puntuación basal, en el estado de salud general/puntuación de la escala QOL del QLQ-C30 de la EORTC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to approx. 21 months
    Up to approx. 5.5 months
    Up to approx. 5.5 months
    at minimum at each study visit and up to approx. 8 months
    C1D1, C1D15, C2D1,C3D1 and C4D1 (a cycle [C] = 4 weeks).
    C1D1, C2D15, C4D1, then every 8 weeks until discontinuation (a cycle [C] = 4 weeks).
    Aproximadamente 21 meses
    Aproximadamente 5.5 meses
    Aproximadamente 5.5 meses
    COmo mínimo en cada visita y aproximadamente cada 8 meses
    C1D1, C1D15, C2D1, C3D1 y C4D1 (un ciclo= 4 semanas)
    C1D1, C2D15, C4D1, entonces cada 8 semanas hasta finalización del estudio.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    fulvestrant
    fulvestrant
    E.8.2.4Number of treatment arms in the trial2
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    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
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of Study is defined as the time point when data collection will stop and the final analysis of the study will occur. The End of Study will be declared depending on the results of the primary analysis.
    El fin del estudio se define como el momento en el tiempo que finaliza la recogida de datos y se va a realizar el análisis final del estudio. El final del estudio se realizará en función de los resultados del análisis primario.
    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 months10
    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 months10
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 405
    F.4.2.2In the whole clinical trial 615
    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)
    After discontinuing study treatment, further treatment is left to the physician?s discretion. No cross over to the BKM120 arm will be allowed.
    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 Decision2012-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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