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    Summary
    EudraCT Number:2013-000833-11
    Sponsor's Protocol Code Number:CBKM120D2205
    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:2013-07-12
    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 number2013-000833-11
    A.3Full title of the trial
    A Phase Ib/II study of docetaxel with or without buparlisib as second line therapy for patients with advanced or metastatic squamous non-small cell lung cancer
    Estudio fase Ib/II de docetaxel con o sin buparlisib, como terapia de segunda línea para pacientes con cáncer de pulmón de células no pequeñas escamoso, metastásico o avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical research study to find out if buparlisib (BKM120) in combination with docetaxel therapy is safe and has beneficial effects in people who have advanced or metastatic squamous non-small cell lung cancer and were previously treated with platinum-based chemotherapy.
    estudio clínico de investigación para averiguar si buparlisib (BKM120) en combinación con la terapia de docetaxel es seguro y tiene efectos beneficiosos en personas con cáncer de pulmón de células no pequeñas escamosas avanzado o metastásico y que fueron tratados previamente con quimioterapia basada en platino.
    A.3.2Name or abbreviated title of the trial where available
    Basalt 3
    Basalt 3
    A.4.1Sponsor's protocol code numberCBKM120D2205
    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 pointDepartamento Médico Oncología (GMO)
    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+34900353036
    B.5.5Fax number+34932479903
    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 namebuparlisib
    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 INNBuparlisib
    D.3.9.1CAS number BKM120
    D.3.9.2Current sponsor codeBKM120
    D.3.9.3Other descriptive nameBKM120 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB32821
    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 namebuparlisib
    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 INNBuparlisib
    D.3.9.1CAS number BKM120
    D.3.9.2Current sponsor codeBKM120
    D.3.9.3Other descriptive nameBKM120 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB32821
    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 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 Yes
    D.2.1.1.1Trade name DOCETAXEL
    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 namedocetaxel
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocetaxel
    D.3.9.1CAS number 148408-66-6
    D.3.9.2Current sponsor codeDocetaxel
    D.3.9.3Other descriptive nameDOCETAXEL TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21602
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 2
    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
    advanced/metastatic squamous non small cell lung cancer
    cáncer escamoso de pulmón avanzado / metastásico de células no pequeñas
    E.1.1.1Medical condition in easily understood language
    lung cancer
    cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10001254
    E.1.2Term Adenosquamous cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10001253
    E.1.2Term Adenosquamous cell lung cancer stage IIIB
    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
    For phase Ib:
    To determine the maximum-tolerated dose (MTD) / recommended Phase II dose (RP2D) of buparlisib when administered orally in combination with every-3-week administration of docetaxel to adult patients with Stage IIIb or Stage IV NSCLC of squamous histology previously treated with platinum-based chemotherapy

    For phase II:
    To estimate the treatment effect of every-three-week administration of docetaxel and daily buparlisib or placebo on PFS in patients previously treated with platinum-based chemotherapy for advanced or metastatic squamous NSCLC
    Fase Ib:
    Determinar la dosis máxima tolerada (DMT) / dosis recomendada para la fase II (DRF2) de buparlisib cuando se administra por vía oral en combinación con docetaxel cada 3 semanas, a pacientes adultos con NSCLC en estadío IIIb o IV de histología escamosa, tratado previamente con quimioterapia basada en platino, medido con las toxicidades limitantes de dosis (TLDs) en el Ciclo 1.
    Fase II:
    Calcular el efecto del tratamiento de la administración cada tres semanas de docetaxel y buparlisib diario o placebo en la supervivencia libre de progresión (SLP) en pacientes con NSCLC escamoso, avanzado o metastásico, tratado previamente con quimioterapia basada en platino, medido con la SLP desde la fecha de la aleatorización hasta la fecha del evento de progresión o muerte.
    E.2.2Secondary objectives of the trial
    For phase Ib:
    - Assess safety and tolerability
    - Assess preliminary activity

    For phase II:
    - Assess safety and tolerability
    - Assess additional efficacy parameters
    - Understand the effect of docetaxel in combination with buparlisib or placebo on patients? symptoms and health-related quality of life (HRQoL)
    - Investigation of the PK of both buparlisib and docetaxel when administered in combination
    Fase Ib:Evaluar la seguridad y la tolerabilidad medida con la frecuencia/severidad de AAs y de anomalías de laboratorio.Evaluar la actividad preliminar, medida con la tasa de respuesta global (TRG), tiempo hasta la respuesta, duración de la respuesta, tasa de SLP a los 3 meses y tasa de SG a los 8 meses
    Fase II:Evaluar la seguridad y la tolerabilidad medida con la frecuencia/severidad de AAs y de anomalías de laboratorio.Evaluar los parámetros de eficacia adicionales medidos con el tiempo desde la aleatorización hasta la muerte por cualquier causa,tasa de mejor respuesta global de respuesta completa(RC)o respuesta parcial(RP)según la versión 1.1 de los RECIST,tiempo desde la aleatorización hasta la respuesta y duración de la respuesta
    Comprender el efecto de docetaxel en combinación con buparlisib o placebo en los síntomas y en la calidad de vida relacionada con la salud (HRQoL) de los pacientes
    Investigación de la PK de buparlisib y docetaxel cuando se administran en combinación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Patient is an adult ? 18 years old at the time of informed consent
    ?Patient has histologically and/or cytologically confirmed diagnosis of squamous NSCLC. Diagnosis of mixed squamous and non-squamous or adenosquamous NSCLC will be acceptable for enrollment.
    ?Patient has received one prior approved regimen of platinum-based chemotherapy (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) squamous NSCLC, followed by disease progression. A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
    Note: Patients who received paclitaxel therapy are eligible for this trial.
    ?Patient has adequate tumor tissue (either archival or new tumor biopsy) for the analysis of PI3K-related biomarkers.
    - Enrollment in the Phase II part of the study is contingent on the central laboratory confirming receipt of an adequate amount of tissue including sufficient DNA for analysis.
    ?Patient has measurable or non-measurable disease according to RECIST version 1.1 criteria.
    - Phase II only: Patient must have at least one measurable lesion as per RECIST criteria.
    ?Patient has an ECOG performance status ? 1
    ?Patient has adequate bone marrow and organ function
    ?Pacientes adultos ? 18 años en el momento del consentimiento informado
    ?Pacientes con diagnóstico confirmado histológicamente y/o citológicamente de NSCLC escamoso. El diagnóstico de NSCLC adenoescamoso o escamoso y no escamoso mixtoserá aceptable para inclusión.
    ?Pacientes que hayan recibido un régimen previo aprobado de quimioterapia basada en platino (excluyendo un régimen que contenga docetaxel) para el NSCLC escamoso, avanzado o metastásico (estadío IIIb o IV), seguido de progresión de la enfermedad. Un fármaco administrado como terapia de mantenimiento tras quimioterapia citotóxica será considerado que forma parte de dicho régimen.
    Nota: Los pacientes que recibieron terapia con paclitaxel serán elegibles para este ensayo.
    ?Pacientes de los que se disponga de tejido de tumor adecuado (almacenado o biopsia de tumor nueva) para el análisis de los biomarcadores relacionados con PI3K.
    ?La inclusión en la parte de la fase II del estudio dependerá de la confirmación del laboratorio central de recepción de una cantidad adecuada de tejido incluyendo suficiente ADN para el análisis.
    ?Pacientes con enfermedad medible o no medible según los criterios de la versión 1.1 de los RECIST.
    ?Sólo fase II: Los pacientes deberán presentar por lo menos una lesión medible según los criterios RECIST.
    ?Pacientes con un estado funcional del ECOG ? 1
    ?Pacientes con función orgánica y de la médula ósea adecuada.
    E.4Principal exclusion criteria
    ?Patient has received previous treatment with a PI3K or AKT inhibitor
    ?Patient has symptomatic Central Nervous System (CNS) metastases
    - Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed prior local treatment, if any, for CNS metastases ? 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or ? 14 days for stereotactic radiosurgery).
    ?Patient has a score ? 12 on the PHQ-9 questionnaire.
    ?Patient selects a response of ?1, 2 or 3? to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9).
    ?Patient has a GAD-7 mood scale score ? 15.
    ?Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation or patients with active severe personality disorders.
    ?Patient has ? CTCAE grade 3 anxiety
    1.Pacientes que hayan recibido tratamiento previo con un inhibidor de PI3K o de AKT
    2.Pacientes con metástasis del sistema nervioso central (SNC) sintomáticas
    ?Los pacientes con metástasis en el SNC asintomáticas pueden participar en el ensayo. El paciente deberá haber completado el tratamiento previo local, si recibió alguno, para las metástasis en el SNC ? 28 días antes del inicio del tratamiento del estudio (incluyendo radioterapia y/o cirugía o ? 14 días para radiocirugía estereotáctica).
    3.El paciente deberá tener una puntuación ? 12 en el cuestionario PHQ-9.
    4.Pacientes que seleccionen una respuesta de ?1, 2 o 3? en la pregunta número 9 del cuestionario PHQ-9 respecto al potencial de ideación o pensamientos de suicidio (independiente de la puntuación local del PHQ-9).
    5.El paciente tiene una puntuación en la escala de estado de ánimo ? 15.
    6.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 o pacientes con trastornos severos activos de la personalidad.
    7.Pacientes con ansiedad ? grado 3 de los CTCAE
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1
    - Progression Free Survival (PFS)
    - Incidencia de TLDs en el ciclo 1
    - SLP según los criterios de evaluación de respuesta en tumores sólidos (RECIST), versión 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Day 21 for incidence of DLT
    - After 70 PFS events have been observed at 9 months after patient enrollment for PFS
    - Día 21 para la incidencia de DLT
    - Después de que se hayan observado 70 eventos PFS a los 9 meses después de la inscripción de pacientes para SSP
    E.5.2Secondary end point(s)
    1. Number of patients with at least one adverse event
    2. Number of patients with laboratory abnormalities
    3. Overall Survival (OS)
    4. Overall response rate (ORR)
    5. Time to response (ToR)
    6. Duration of response (DR)
    7. Change in electrocardiogram (ECG) and cardiac imaging
    8. Changes in vital signs
    9. Shift in ECOG performance status
    10. Change in Mood scales
    11. Time to definitive 10% deterioration in the global health status/quality of life (QOL) scale score of the EORTC QLQ-C30
    12. Change in the global health status/quality of life (QOL) scale score of the EORTC QLQ-C30
    13. Docetaxel and buparlisib plasma concentrations
    14. PFS Phase Ib)
    Frecuencia/severidad de AAs, anomalías de laboratorio
    Tasa de respuesta global (TRG), tiempo hasta la respuesta, duración de la respuesta, tasa de SLP a los 3 meses y la tasa de SG a los 8 meses
    Análisis molecular incluyendo estado molecular de PI3K incluido pero no limitado a PIK3CA y mutaciones PTEN, expresión de proteína PTEN
    Análisis proteómico y genómico de biopsia de tumor recogida en el momento de la progresión a través del tratamiento (la biopsia es opcional)
    Frecuencia/severidad de AAs, labs
    SG: el tiempo desde la aleatorización hasta la fecha de la muerte por cualquier causa
    TRG: Mejor tasa de respuesta global de RC o RP según la versión 1.1 de los RECIST
    Tiempo hasta la respuesta
    Duración de la respuesta
    Tiempo hasta el deterioro definitivo del 10% en el estado de salud global/puntuación de la escala de calidad de vida (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
    Concentraciones plasmáticas de docetaxel y buparlisib.
    Parámetros de eficacia clínica según la activación de la vía de señalización PI3K
    Análisis molecular como amplificación del gen PIK3CA, mutación de PIK3R1, mutación KRAS (homólogo del oncogén V-Ki-ras 2 del virus del sarcoma en rata Kirsten), etc. en tejido del tumor o ADN en plasma circulante según la respuesta clínica.
    Correlación entre la exposición al tratamiento y la inhibición de la vía de señalización, medida con la inhibición de pAKT y p4EBP1 en PBMCs
    Análisis proteómico y genómico de biopsia de tumor recogida en el momento de la progresión a través del tratamiento (la biopsia es opcional)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints number:
    1, 2, 7, 8 & 10: treatment start until 30 days after the last dose
    3: : 8 months (Phase Ib) and from time of randomization to death (Phase II)
    4: time from start date of study treatment in Phase Ib and from date of randomization in phase II to the date of first documented response
    5: date of start of study treatment in Phase Ib and date of randomization in phase II to the date of first documented response
    6: date of first documented response, the following date of event
    9: Baseline, worst post-baseline result
    11: date of randomization, date of event
    12: baseline, at time of each assessment
    13: cycle 1, end of treatment
    14: start date of treatment, 3 months, date or progression or death
    1,2,7,8y10:el inicio del tratamiento hasta 30 días después de la última dosis
    3:8 meses(fase Ib)y desde el momento de la asignación al azar hasta la muerte(Fase II)
    4:tiempo desde la fecha de inicio del tratamiento del estudio en FaseIb y desde la fecha de la asignación al azar en la faseII de la fecha de primera respuesta documentada
    5:Fecha de inicio del tratamiento del estudio en FaseIb y la fecha de la asignación al azar en la faseII de la fecha de la primera respuesta documentada
    6:Fecha de la primera respuesta documentada
    9:el peor resultado después de la línea de base
    11:Fecha de la asignación al azar,fecha del evento
    12:en el momento de cada evaluación
    13:Ciclo 1,al final del tratamiento
    14:Fecha de inicio del tratamiento,3 meses,fecha,progresión o 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib
    Ib/II
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA52
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    China
    Colombia
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Norway
    Poland
    Russian Federation
    Slovakia
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    United Kingdom
    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
    Phase Ib part:
    All patients have discontinued treatment and have completed:
    - 8 months survival follow up (in case phase II part is not initiated)
    - 30 days safety follow up (in case phase II part is initiated)

    Phase II part:
    At the latest occurence of:
    - at least 1 year has elapsed since the data cut off for primary analysis and all patients have completed the safety follow up
    - at least 75% of deaths have been observed
    Fase Ib:
    Todos los pacientes que han interrumpido el tratamiento y han completado:
    -8 meses de supervivencia de seguimiento(en caso de que parte de la fase II no se inicia)
    -30 días de seguimiento de seguridad(en caso de que parte de la fase II se inicia)
    Fase II:
    -Ha transcurrido por lo menos 1 año desde que los datos cortados para el análisis primario y todos los pacientes han completado el seguimiento de seguridad
    -Se han observado al menos el 75% de las muertes
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 211
    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
    Después de discontinuar el tratamiento del estudio, el tratamiento posterior se deja a discreción del médico.
    Se permitirá no transversal al brazo BKM120.
    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 Decision2013-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-04
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