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    Summary
    EudraCT Number:2015-000905-38
    Sponsor's Protocol Code Number:PCYC-1137-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:2015-10-05
    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 number2015-000905-38
    A.3Full title of the trial
    A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton?s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma
    Estudio aleatorizado, multicéntrico, doble ciego, controlado con placebo, de fase 2/3 del inhibidor de la tirosina quinasa de Bruton, ibrutinib, en combinación con nab-paclitaxel y gemcitabina frente a placebo en combinación con nab-paclitaxel y gemcitabina, en el tratamiento de primera línea de pacientes con adenocarcinoma de páncreas metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the use of Ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in patients with metastatic pancreatic adenocarcinoma
    Estudio para evaluar el uso de ibrutinib en combinación con nab-paclitaxel y gemcitabina frente a placebo en combinación con nab-paclitaxel y gemcitabina, en pacientes con adenocarcinoma de páncreas metastásico.
    A.4.1Sponsor's protocol code numberPCYC-1137-CA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02436668
    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 LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmacyclics LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles S.L.
    B.5.2Functional name of contact pointCall Center
    B.5.3 Address:
    B.5.3.1Street Address995 East Arques Avenue
    B.5.3.2Town/ citySunnyvale, California
    B.5.3.3Post code94085-4521
    B.5.3.4CountryUnited States
    B.5.4Telephone number900 866662124
    B.5.6E-mailinfo@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 Yes
    D.2.1.1.1Trade name IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen/Cilag International NV
    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 nameIMBRUVICA
    D.3.2Product code PCI-32765
    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 ABRAXANE
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 nameABRAXANE
    D.3.4Pharmaceutical form 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 INNNab-paclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.9.3Other descriptive namePACLITAXEL ALBUMIN-BOUND
    D.3.9.4EV Substance CodeSUB127678
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameGemcitabine
    D.3.4Pharmaceutical form 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 INNGemcitabine
    D.3.9.1CAS number 95058-81-4
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    metastatic pancreatic adenocarcinoma
    adenocarcinoma de páncreas metastásico
    E.1.1.1Medical condition in easily understood language
    metastatic pancreatic adenocarcinoma
    adenocarcinoma de páncreas metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    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
    The primary objective of the study is to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, based on investigator assessment of progression-free survival (PFS), for the first line treatment of patients with metastatic pancreatic adenocarcinoma.
    Evaluar la eficacia de ibrutinib en combinación con nab-paclitaxel y gemcitabina frente a placebo en combinación con nab-paclitaxel y gemcitabina, según la evaluación realizada por el investigador de la supervivencia sin progresión (SSP), en el tratamiento de primera línea de pacientes con adenocarcinoma de páncreas metastásico.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the following:
    Efficacy
    - Overall survival (OS)
    - Clinical benefit response (CBR) rate
    - Overall response rate (ORR): complete response (CR) + partial response (PR), per investigator assessment
    - Carbohydrate antigen 19-9 (CA19-9) response
    - Patient-reported outcome (PRO) by EORTC QLQ-C30
    Safety
    - To evaluate the safety and tolerability of ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine
    Objetivos secundarios:
    Eficacia
    - Supervivencia general (SG)
    - Tasa de respuesta de beneficio clínico (RBC)
    - Tasa de respuesta global (TRG): respuesta completa (RC) + respuesta parcial (RP), según la evaluación del investigador
    - Respuesta del antígeno glucídico 19-9 (CA19-9)
    - Resultados comunicados por los pacientes (RCP) mediante el QLQ-C30 de la EORTC
    Seguridad
    - Evaluar la seguridad y la tolerabilidad de ibrutinib en combinación con nab-paclitaxel y gemcitabina frente a placebo en combinación con nab-paclitaxel y gemcitabina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be enrolled in the study, each potential subject must satisfy all of the following inclusion criteria.
    1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
    2. Stage IV disease diagnosed within 6 weeks of randomization.
    3. Disease which is evaluable according to RECIST 1.1, with at least one measurable metastatic lesion (not in a previously irradiated area).
    4. Disease status for which, in the opinion of the investigator, nab-paclitaxel and gemcitabine is considered an appropriate treatment choice.
    5. No previous radiotherapy, surgery, cytotoxic chemotherapy or investigational therapy for the treatment of metastatic pancreatic adenocarcinoma.
    6. No prior neo-adjuvant, peri-operative or adjuvant chemotherapy for primary disease of pancreaatic adenocarcinoma. Prior treatment with 5-FU, gemcitabine or capecitabine administered as a radiation sensitizer (at non-cytotoxic doses) in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose.
    7. No clinically significant third-space fluid accumulation (eg, ascites or pleural effusion).
    8. Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study medication.
    9. Ability to provide written informed consent and to understand and comply with the requirements of the study.
    Laboratory
    10. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to randomization:
    - Absolute neutrophil count (ANC) 1.5 x 109/L
    - Platelet count 100 x 109/L
    - Hemoglobin 9 g/dL
    11. Adequate hepatic and renal function defined as:
    ? Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) 5.0 x upper limit of normal (ULN) if liver metastases, or 3 x ULN without liver metastases
    - Alkaline phosphatase <3.0 x ULN or 5.0 x ULN if liver or bone metastases present
    - Bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilberts syndrome or of non-hepatic origin, such as hemolysis)
    - Estimated Creatinine Clearance 30 mL/min (Cockcroft-Gault)
    12. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN.
    Demographic
    13. Men and women over 18 years of age.
    14. Karnofsky performance status (KPS) 70. Two observers will be required to assess KPS at screening. If discrepant, the one with the lowest assessment will be accepted.
    15.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    Para poder ser inscritos en el estudio, cada uno de los posibles sujetos debe cumplir todos los criterios de inclusión siguientes.

    1. Diagnóstico de adenocarcinoma pancreático confirmado mediante estudio histológico o citológico.
    2. Neoplasia de estadio IV diagnosticada en las 6 semanas previas a la aleatorización.
    3. Neoplasia evaluable según RECIST 1.1, con al menos una lesión metastásica medible (no en una zona irradiada anteriormente).
    4. Estado de la enfermedad para el cual el investigador considere que el nab-paclitaxel y la gemcitabina sean una opción de tratamiento adecuada.
    5. Ausencia de uso previo de radioterapia, cirugía, quimioterapia citotóxica o tratamiento experimental para el adenocarcinoma pancreático metastásico.
    6. Ausencia de quimioterapia previa neoadyuvante, perioperatoria o adyuvante para el adenocarcinoma pancreático primario. Se permite el tratamiento adyuvante previo con 5-FU, gemcitabina o capecitabina administrados como radiosensibilizadores (a dosis no citotóxicas), siempre y cuando hayan transcurrido al menos 6 meses desde la finalización de la última dosis.
    7. Ausencia de acumulación clínicamente significativa de líquidos en el tercer espacio (p. ej., ascitis o derrame pleural).
    8. Sujetos de sexo masculino y femenino que acepten utilizar métodos anticonceptivos altamente eficaces (por ejemplo, preservativos, implantes, inyecciones, anticonceptivos orales combinados, ciertos dispositivos intrauterinos [DIU], abstinencia sexual o pareja esterilizada) durante el período de tratamiento y durante los 90 días siguientes a la última dosis de medicación del estudio.
    9. Capacidad para dar el consentimiento informado por escrito y para entender y cumplir con los requisitos del estudio.
    Laboratorio
    10. Funcionamiento hematológico adecuado sin necesidad de transfusiones ni de apoyo con factor de crecimiento durante al menos 7 días antes de la aleatorización:
    - Recuento absoluto de neutrófilos (RAN) 1,5 x 109/l
    - Recuento de plaquetas 100 x 109/l
    - Hemoglobina 9 g/dl
    11. Función hepática y renal adecuadas, que se definen como:
    - Aspartato-aminotransferasa (AST) o alanina-aminotransferasa (ALT) en suero 5,0 x límite superior de la normalidad (LSN) si hay metástasis hepática, o bien ? 3 x LSN sin metástasis hepática
    - Fosfatasa alcalina < 3,0 x LSN o 5,0 x LSN en presencia de metástasis hepáticas u óseas
    - Bilirrubina 1,5 x LSN (a menos que el aumento de la bilirrubina se deba a síndrome de Gilbert o sea de origen no hepático, como hemólisis)
    - Aclaramiento de creatinina estimado 30 ml/min (Cockcroft-Gault)
    12. TP/INR < 1,5 x LSN y TTP (TTPa) < 1,5 x LSN.

    Datos demográficos
    13. Hombres y mujeres mayor de 18 años de edad.
    14. Estado general de Karnofsky (EGK) 70. Serán necesarios dos observadores para evaluar el EGK en la Selección. En caso de discrepancia, se aceptará el que realice la evaluación más baja.
    15. Estado funcional según el Grupo de Colaboración de Oncología del Este (Eastern Cooperative Oncology Group, ECOG) de 0-1.
    E.4Principal exclusion criteria
    To be enrolled in the study, potential subjects must meet NONE of the following exclusion criteria:
    Disease-related
    1. Prior radiotherapy to any measurable lesion at any time.
    2. Radiotherapy in the adjuvant setting, or earlier, within the last six months.
    3. Previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
    4. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
    Concurrent Conditions
    5. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
    6. Prior exposure to BTK inhibitor.
    7. A documented ?10% decrease in KPS between screening visit and within 72 hours prior to randomization.
    8. History of other malignancies, except:
    ? Malignancy treated with curative intent and with no known active disease present for ?3 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    ? Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    ? Adequately treated carcinoma in situ without current evidence of disease.
    9. Known bleeding disorders (eg, von Willebrand?s disease or hemophilia).
    10. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
    11. Any uncontrolled active systemic infection including any infection requiring systemic IV treatment which was completed 7 days before randomization.
    12. Major surgery within 4 weeks of first dose of study drug.
    13. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator?s opinion, could compromise the subject?s safety or put the study outcomes at undue risk.
    14. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    15. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
    16. History of interstitial lung disease, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
    17. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
    18. Concomitant use of warfarin or other Vitamin K antagonists.
    19. Known hypersensitivity to any study drug (nab-paclitaxel, gemcitabine, or ibrutinib)
    20. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
    21. Lactating or pregnant.
    22. Unwilling or unable to participate in all required study evaluations and procedures.
    23. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
    24. Decline in serum albumin more or equal than 20% from Screening to study randomization.
    Para ser inscritos en el estudio, los potenciales sujetos no deben cumplir NINGUNO de los criterios de exclusión siguientes:
    Relacionados con la enfermedad
    1. Radioterapia previa para cualquier lesión medible en algún momento.
    2. Radioterapia adyuvante o anterior en los últimos seis meses.
    3. Quimioterapia citotóxica previa para el adenocarcinoma pancreático primario.
    4. Carcinoma pancreático neuroendocrino (carcinoide, insulinoma) o acinar.

    Enfermedades concomitantes
    5. Afectación cerebral o leptomeníngea conocida (solo será necesaria TAC o RM cerebral en caso de sospecha clínica de afectación del sistema nervioso central).
    6. Exposición previa a un inhibidor de la BTK.
    7. Descenso documentado ? 10 % en el EGK entre la visita de selección y en las 72 horas previas a la aleatorización.
    8. Historial de otras neoplasias malignas, excepto:
    ? Neoplasia maligna tratada con intención curativa y sin enfermedad activa conocida presente durante ? 3 años antes de la primera dosis del fármaco del estudio y que parezca tener bajo riesgo de recurrencia para el investigador.
    ? Cáncer de piel de tipo no melanoma tratado adecuadamente o lentigo maligno sin evidencia de enfermedad.
    ? Carcinoma in situ tratado adecuadamente y sin evidencia de enfermedad actual.

    9. Trastornos de coagulación conocidos (por ejemplo, enfermedad de von Willebrand o hemofilia).
    10. Antecedentes conocidos de virus de inmunodeficiencia humana (VIH) o virus de hepatitis C (VHC) o de hepatitis B (VHB) activos. Los sujetos que den positivo para anticuerpos contra el antígeno nuclear de la hepatitis B, antígeno de superficie de hepatitis B o anticuerpos de la hepatitis C deben tener un resultado negativo en la reacción en cadena de polimerasa (PCR) antes de la inscripción. Los que den positivo en la PCR serán excluidos.
    11. Cualquier infección sistémica activa no controlada, incluidas infecciones que requieran tratamiento sistémico IV que haya terminado 7 días antes de la aleatorización.
    12. Cirugía mayor en las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    13. Cualquier enfermedad, estado de salud o disfunción del sistema de órganos potencialmente mortales que, en opinión del investigador, podría poner en peligro la seguridad del sujeto o poner en riesgo indebido los resultados del estudio.
    14. Antecedentes de ictus o hemorragia intracraneal dentro de los 6 meses anteriores a la inscripción.
    15. Enfermedad cardiovascular clínicamente significativa y actualmente activa, como arritmia no controlada o Clase 3 o 4 de insuficiencia cardíaca congestiva según la definición de la Clasificación funcional de la New York Heart Association; o antecedentes de infarto de miocardio, angina inestable o síndrome coronario agudo en los 6 meses previos a la aleatorización.
    16. Antecedentes de enfermedad pulmonar intersticial, fibrosis pulmonar idiopática o neumonitis por hipersensibilidad.
    17. No poder ingerir cápsulas o síndrome de mala absorción, enfermedad que afecta significativamente a la función gastrointestinal o resección del estómago o del intestino delgado, enfermedad intestinal inflamatoria sintomática o colitis ulcerosa, u obstrucción intestinal parcial o completa.
    18. Uso concomitante de warfarina u otros antagonistas de la vitamina K.
    19. Hipersensibilidad conocida a cualquiera de los fármacos del estudio (nab-paclitaxel, gemcitabina o ibrutinib).
    20. Requiere un tratamiento con un inhibidor 3A del citocromo P450 (CYP) potente.
    21. En período de lactancia o embarazadas.
    22. No tener disposición para participar o no poder participar en todas las evaluaciones y los procedimientos del estudio requeridos.
    23. No poder entender el propósito y los riesgos del estudio y proporcionar un formulario de consentimiento informado (FCI) firmado y fechado y la autorización de uso de la información de salud protegida (de conformidad con las regulaciones de privacidad del sujeto nacionales y locales).
    24. Descenso de la albúmina sérica 20 % desde la Selección hasta la aleatorización para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is progression free survival, as determined by investigator assessment, according to RECIST 1.1 criteria.
    El objetivo primario es la supervivencia sin progresión (SSP), según la evaluación realizada por el investigador, según los cirterios RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout all the study
    A lo largo de todo el estudio
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Clinical benefit response (CBR) rate
    - Overall response rate (ORR): CR + PR, per investigator assessment
    - Carbohydrate antigen 19-9 (CA19-9) response
    - Patient-reported outcomes (PRO): global health status based on QLQ-C30

    Other Secondary Endpoints: the safety and tolerability of ibrutinib/placebo in combination with nab-paclitaxel and gemcitabine versus the combination of placebo with nab-paclitaxel and gemcitabine
    - Supervivencia general (SG)
    - Tasa de respuesta de beneficio clínico (RBC)
    - Tasa de respuesta global (TRG): respuesta completa (RC) + respuesta parcial (RP), según la evaluación del investigador
    - Respuesta del antígeno glucídico 19-9 (CA19-9)
    - Resultados comunicados por los pacientes (RCP) mediante el QLQ-C30 de la EORTC
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout all the study
    A lo largo de todo el 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 No
    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 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) Yes
    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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Belgium
    France
    Germany
    Italy
    Korea, Republic of
    Spain
    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
    LVLS
    LVLS
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 196
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 326
    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)
    All subjects will undergo an End-of-Treatment (EOT) Visit within 30 days from either 1) the last dose of ibrutinib/placebo, or 2) the last administration of nab-paclitaxel and/or gemcitabine, whichever occurs last. All subjects then will be followed for disease progression, survival and subsequent anti-cancer therapies. Follow-up phase will continue until death, lost to follow-up, consent withdrawal, or study closure, whichever occurs first.
    Todos los sujetos acudirán a una visita de final de tratamiento (FdT) dentro de los 30 días siguientes a 1)la última dosis de ibrutinib/placebo,o 2)la última administración de nab-paclitaxel y/o gemcitabina,lo que ocurre después.Se hará un seguimiento a todos los pacientes de progresión de la enfermedad,supervivencia,y tratamientos oncológicos posteriores.La fase de seguimiento continuará hasta la muerte,pérdida de seguimiento,retirada de consentimiento, cierre del estudio,lo que ocurra primero.
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-25
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