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    Summary
    EudraCT Number:2015-005105-36
    Sponsor's Protocol Code Number:PCYC-1139-CA
    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:2016-05-17
    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 number2015-005105-36
    A.3Full title of the trial
    An Open-label study of Ibrutinib in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or
    Relapsed and Refractory Multiple Myeloma.
    Estudio abierto de ibrutinib en combinación con bortezomib y dexametasona en pacientes con mieloma múltiple recurrente o recurrente y resistente al tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Ibrutinib in Combination with Bortezomib and Dexamethasone in Multiple Myeloma Patients
    Estudio de ibrutinib en combinación con bortezomib y dexametasona en pacientes con mieloma múltiple.
    A.4.1Sponsor's protocol code numberPCYC-1139-CA
    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 SponsorPharmacyclics Switzerland GmbH
    B.1.3.4CountrySwitzerland
    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 supportPharmacyclics Switzerland GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Albert Oriol Rocafiguera
    B.5.2Functional name of contact pointNational Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda Granvia, 199-203
    B.5.3.2Town/ cityL'Hospitalet de Llobregat, Barcelona
    B.5.3.3Post code08908
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934978574
    B.5.5Fax number+1 (408) 215 3684
    B.5.6E-mailebilotti@pcyc.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 nameIbrutinib
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codePCI 32675
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    D.2.1.1.1Trade name VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameBortezomib
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.3Other descriptive nameBortezomib
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 FORTECORTIN
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/745
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    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 INNDEXAMETHASONE
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive nameDexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive nameDexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 4
    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 FORTECORTIN
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/745
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.2Product code H 02 AB 02
    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 INNDEXAMETHASONE
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive nameDexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Relapsed or Relapsed and Refractory Multiple Myeloma (MM)
    Mieloma múltiple (MM) recurrente o recurrente y resistente.
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma - cancer of white blood cells
    Mieloma Múltiple - cancer de glóbulos blancos
    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 10028228
    E.1.2Term Multiple myeloma
    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 evaluate Progression-Free Survival (PFS) according to International Myeloma Working Group (IMWG) response criteria (Rajkumar 2011) in subjects with relapsed or relapsed and refractory MM.
    Evaluar la supervivencia sin progresión (SSP) de acuerdo con los criterios de respuesta del Grupo de Trabajo Internacional del Mieloma (International Myeloma Working Group, IMWG) (Rajkumar 2011) en sujetos con MM recurrente o recurrente y resistente al tratamiento.
    E.2.2Secondary objectives of the trial
    ? Overall Response Rate (?PR)
    ? PFS Rate at Landmark Points
    ? Duration of Response (DOR)
    ? Overall Survival (OS)
    ? Time to Progression (TTP)
    ? To evaluate the safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone.
    ? Tasa de respuesta general (? RP)
    ? Tasa de SSP en los puntos de referencia
    ? Duración de la respuesta (DR)
    ? Supervivencia global (SG)
    ? Tiempo transcurrido hasta la progresión (TTP)
    ? Evaluar la seguridad y la tolerabilidad del ibrutinib en combinación con bortezomib y dexametasona.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with MM who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen.
    2. Measurable disease defined by at least ONE of the following:
    ? Serum monoclonal protein (SPEP) ?1 g/dL
    ? Urine monoclonal protein (UPEP) ?200 mg by 24 hour urine electrophoresis
    3. Adequate hematologic function
    4. Adequate hepatic and renal function
    5. Prothrombin time (PT)/ International normal ratio (INR) ?1.5 x upper limit of normal (ULN)
    and PTT (activated partial thromboplastin time [aPTT]) ?1.5 x ULN
    6. Male and female ?18 years of age
    7. Eastern Cooperative Oncology Group (ECOG) performance status of ?2.
    8. Male and female subjects of reproductive potential who agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study treatment. Female subjects who are of non-reproductive potential. Female subjects of reproductive potential must have a negative serum pregnancy test upon study entry.
    Other protocol-defined inclusion criteria could apply
    1. Sujetos con MM que han recibido 1-3 líneas de tratamiento anteriores y han demostrado enfermedad progresiva desde la finalización de la pauta de tratamiento más reciente.
    2. Enfermedad cuantificable definida como mínimo por UNO de los siguientes aspectos:
    - Proteína monoclonal en suero (EFPS) ?1 g/dl. (para sujetos con MM IgA, IgD, IgE o IgM SPEP ?0.5 g/dL)
    - Proteína monoclonal en orina (EFPO) ? 200 mg en 24 horas de electroforesis.
    3. Función hematológica adecuada.
    4. Función hepática y renal adecuada
    5. TP/INR ? 1,5 veces el LSN y TTP (TTPa) ? 1,5 veces el LSN.
    6. Hombres y mujeres ? 18 años de edad
    7. Estado funcional del Eastern Cooperative Oncology Group (ECOG) ? 2
    8. Los sujetos de ambos sexos que tengan capacidad reproductiva deben utilizar métodos anticonceptivos de alta eficacia durante el período del tratamiento y durante 90 días después de la última dosis del tratamiento del estudio. Sujetos del sexo femenino que no tengan capacidad reproductiva. Las mujeres en edad fértil deben dar negativo en una prueba de embarazo en suero en el momento del ingreso en el estudio.
    Otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    1. Primary refractory disease defined as nonresponsive in patients who have never achieved a minimal response or better with any therapy.
    2. History of plasma cell leukemia, primary amyloidosis, POEMS syndrome within 12 months prior to first administration of study treatment.
    3. Recent prior chemotherapy
    4. Prior exposure to BTK inhibitors
    5. Refractory or non-responsive to prior PI therapy (bortezomib or carfilzomib)
    6. History of hypersensitivity reactions to prior bortezomib, to boron, mannitol or nitrogen.
    7. History of other malignancies
    8. Peripheral neuropathy Grade ?2 or Grade 1 with pain at Screening
    9. Prior allogeneic stem cell transplant
    10. Recent infection requiring systemic treatment that was completed <7 days before the first administration of study treatment and/or uncontrolled active
    systemic infection.
    11. Unresolved toxicities from prior anti-cancer therapy
    12. Known bleeding disorders (eg, von Willebrand?s disease or hemophilia)
    13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    14. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV)
    15. Major surgery within 4 weeks of first administration of study treatment.
    16. Any life-threatening illness, medical condition, including uncontrolled Diabetes Mellitus, or organ system dysfunction
    17. Currently active, clinically significant hepatic impairment
    18. Currently active, clinically significant cardiovascular disease
    19. Unable to swallow capsules or malabsorption syndrome
    20. Subjects who received a strong cytochrome P (CYP) 450 3A inhibitor within 7 days prior to the first administration of study treatment or subjects who require continuous treatment with a strong CYP 3A
    inhibitor
    21. Lactating or pregnant
    Other protocol-defined exclusion criteria could apply
    1. Enfermedad primaria resistente al tratamiento definida como ausencia de respuesta en pacientes que nunca han logrado una respuesta mínima o mejor con ningún tratamiento.
    2. Antecedentes de leucemia de células plasmáticas, amiloidosis primaria, síndrome de POEMS en los 12 meses anteriores a la primera administración del tratamiento del estudio.
    3. Quimioterapia anterior reciente
    4. Exposición anterior a inhibidores de BTK.
    5. Ser resistente al tratamiento o no responder al tratamiento anterior con IP (bortezomib o carfilzomib).
    6. Antecedentes de reacciones de hipersensibilidad a la administración anterior de bortezomib, boro, manitol o nitrógeno.
    7. Antecedentes de otras neoplasias malignas.
    8. Neuropatía periférica de grado ? 2 o de grado 1 con dolor en la selección.
    9. Trasplante de células madre alogénico anterior.
    10. Infección reciente que requiere tratamiento sistémico que se haya completado < 7 días antes de la primera administración del tratamiento del estudio o infección sistémica activa no controlada.
    11. Toxicidades no resueltas derivadas del tratamiento contra el cáncer anterior.
    12. Trastornos de la coagulación conocidos (p. ej., enfermedad de von Willebrand o hemofilia).
    13. Antecedentes de ictus o hemorragia intracraneal en los 6 meses anteriores a la inscripción.
    14. Antecedentes conocidos de virus de inmunodeficiencia humana (VIH) o actividad del virus de la hepatitis C (VHC) o virus de la hepatitis B (VHB).
    15. Cirugía mayor en las 4 semanas anteriores a la primera administración del tratamiento del estudio.
    16. Cualquier enfermedad o estado de salud potencialmente mortales, incluyendo diabetes mellitus no controlada o disfunción de un sistema de órganos.
    17. Insuficiencia hepática activa y clínicamente significativa en la actualidad.
    18. Enfermedad cardiovascular activa y clínicamente significativa en la actualidad.
    19. Incapacidad para ingerir cápsulas o síndrome de mala absorción.
    20. Sujetos que han recibido un inhibidor potente del citocromo P (CYP) 450 3A en los 7 días anteriores a la primera administración del tratamiento del estudio o sujetos que requieren tratamiento continuo con un inhibidor potente de CYP 3A.
    21. Estar en período de lactancia o embarazada.
    Otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first. The mPFS is the time at which the percentage or probability of surviving and progression-free is 50%. The mPFS will be assessed according to the IMWG response criteria
    El criterio de valoración principal de la eficacia de este estudio es la SSPM. La supervivencia sin progresión se define como el tiempo desde la fecha de la primera dosis del tratamiento del estudio hasta la enfermedad progresiva confirmada o muerte por cualquier causa, lo que ocurra primero. La MSSP es el momento en el que el porcentaje o la probabilidad de sobrevivir y de no tener progresión son del 50 %. La MSSP se evaluará de acuerdo con los criterios de respuesta del IMWG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned to include data up to 12 months after the last subject is enrolled or 83 PFS events, whichever occur earlier. This is estimated to occur Q3 2019.
    Está previsto que el análisis principal para el informe del estudio clínico incluya los datos hasta 12 meses después de la inscripción del último sujeto o de que se produzcan 83 acontecimientos de SSP, lo que ocurra antes. Esto se estima para el Q3 2019.
    E.5.2Secondary end point(s)
    ? ORR is the proportion of subjects who achieve a PR or better over the course of the study but prior to initiation of subsequent anti-cancer therapy.
    ? PFS rates at landmark points are the percentages or probabilities of surviving and progression-free at the landmark time points. The landmark time points will be described further in the SAP.
    ? The DOR is defined as the interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring if applicable, for responders only. Responders are subjects in the ITT population who achieve PR or better according to the IMWG response criteria. Non
    responders (?PR) will be excluded from the analysis for DOR.
    ? OS is defined as the time from the date of first dose of study treatment until date of death due to any cause.
    ? TTP is defined as the time from the start of treatment until date of disease progression. Subjects who die due to causes other than disease progression will be censored at the date of death.
    - La TRG es la proporción de sujetos que logran una RP o mejor durante el transcurso del estudio, pero antes de iniciar el tratamiento oncológico posterior.
    - Las tasas de SSP en los puntos de referencia son los porcentajes o las probabilidades de sobrevivir y no tener progresión en los puntos temporales de referencia. Los puntos temporales de referencia se describirán más detenidamente en el PAE.
    - La DR se define como el intervalo entre la fecha de la documentación inicial de una respuesta y la fecha de la primera prueba documentada de enfermedad progresiva, la muerte, o la fecha de censura estadística en su caso, solamente para los sujetos con respuesta. Los sujetos con respuesta son los de la población de ITT que logran una RP o mejor, de acuerdo con los criterios de respuesta del IMWG. Los sujetos sin respuesta (? RP) serán excluidos del análisis de DR.
    - La SG se define como el tiempo desde la fecha de la primera dosis del tratamiento del estudio hasta la fecha de muerte por cualquier causa.
    - El TTP se define como el tiempo desde el inicio del tratamiento hasta la fecha de enfermedad progresiva. Los sujetos que mueren por causas distintas a la enfermedad progresiva serán censurados de la estadística en la fecha del fallecimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis of secondary endpoints will also occur at the time of the primary analysis. In addition, a final analysis will occur at the time of study closure and may include updates to the secondary endpoints as applicable for those subjects either continuing on treatment at the time of the primary analysis or those that have discontinued treatment but not yet experienced an event (progression or death).
    El análisis de los criterios de valoración secundarios ocurrirá al mismo tiempo que el análisis principal. Adicionalmente, un análisis final ocurrirá en el momento de cierre del estudio y podrá incluir actualizaciones al criterio secundario aplicable a aquellos sujetos que continuen con el tratamiento en el momento del análisis principal, or aquellos que hayan discontinuado el tratamiento pero no hayan tenido ningún evento (progresión o fallecimiento).
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Czech Republic
    France
    Germany
    Greece
    Italy
    Poland
    Spain
    Turkey
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 125
    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 that will complete participation in this study due to disease progression, unacceptable toxicity, or withdrawal of informed consent, will be treated outside the study at the discretion of their study doctor.
    Patients benefiting from treatment with ibrutinib at the end of the study will be offered continued access to ibrutinib in a clinical study or registry at least until ibrutinib becomes commercially available for their indication in their country.
    Los pacientes que completen su participación en el estudio por progresión de la enfermedad, toxicidad inaceptable, retirada de consentimiento informado, será tratados fuera del estudio a discreción de su médico del estudio. Los pacientes que se beneficien del tratamiento con Ibrutinib al final del estudio, se le pfrecerá acceso continuo de ibrutinib en un estudio clínico por lo menos hasta que ibrutinib esté disponible para su indicación en su país.
    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 Decision2016-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-26
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