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    Summary
    EudraCT Number:2016-002036-32
    Sponsor's Protocol Code Number:MDV3800-06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-17
    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 number2016-002036-32
    A.3Full title of the trial
    A Phase 2, Open-Label, 2-Arm, Response Rate Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)
    Estudio en fase II, abierto y con dos grupos de la tasa de respuesta de talazoparib en hombres con defectos de reparación del ADN y cáncer de próstata metastásico resistente a la castración que recibieron con anterioridad quimioterapia basada en taxanos y que progresó con al menos 1 fármaco hormonal nuevo (enzalutamida o acetato de abiraterona/prednisona)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study to evaluate the effectiveness of Talazoparib in men with a genomic defect and metastatic castration-resistant prostate cancer who received previous chemotherapy and progressed on hormonal treatment
    Estudio Internacional para evaluar la eficacia de Talazoparib en hombres con defecto genómico y cáncer de próstata metastásico resistente a la castración que recibieron previamente quimioterapia y progresaron en tratamiento hormonal
    A.4.1Sponsor's protocol code numberMDV3800-06
    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 SponsorMedivation, Inc.
    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 supportMedivation, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedivation, Inc.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address525 Market Street, 36th Floor
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post codeCA 94015
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34948255 400
    B.5.5Fax number14155433411
    B.5.6E-maildg-MDV3800-06@medivation.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 nameTalazoparib
    D.3.2Product code MDV3800 (BMN 673)
    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 INNTalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeMDV3800
    D.3.9.3Other descriptive nameBMN 673
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 nameTalazoparib
    D.3.2Product code MDV3800 (BMN 673)
    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 INNTalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeMDV3800
    D.3.9.3Other descriptive nameBMN 673
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)
    Hombres con defectos de reparación del ADN y cáncer de próstata metastásico resistente a la castración que recibieron con anterioridad quimioterapia basada en taxanos y que progresó con al menos 1 fármaco hormonal nuevo (enzalutamida o acetato de abiraterona/prednisona)
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cancer de Prostata
    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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy, as measured by best objective response rate (ORR)
    Evaluar la eficacia, determinada por la mejor tasa de respuesta objetiva (TRO)
    E.2.2Secondary objectives of the trial
    • Time to objective response
    • Duration of response
    • Proportion of patients with prostate-specific antigen (PSA) response ≥ 50%
    • Proportion of patients with conversion of circulating tumor cell (CTC) count
    • Time to PSA progression
    • Radiographic progression-free survival (PFS)
    • Overall survival
    • Pain as assessed by the Brief Pain Inventory Short Form (BPI-SF)
    • Patient-reported outcome as assessed by the European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L)
    • Safety
    • Pharmacokinetics (PK) of talazoparib
     Tiempo hasta la respuesta objetiva
     Duración de la respuesta
     Proporción de pacientes con respuesta al antígeno prostático específico (prostate-specific antigen, PSA) ≥50 %
     Proporción de pacientes con conversión del recuento de células tumorales circulantes (CTC)
     Tiempo hasta la progresión del PSA
     Supervivencia sin progresión (SSP) radiográfica
     Supervivencia general
     Dolor evaluado según la versión abreviada del cuestionario breve de evaluación del dolor (Brief Pain Inventory Short Form, BPI-SF)
     Resultados comunicados por el paciente según la escala del Cuestionario europeo sobre la calidad de vida de 5 dimensiones y 5 niveles (European Quality of Life 5-Domain 5-Level Scale, EQ-5D-5L)
     Seguridad
     Farmacocinética (FC) de talazoparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -At least 18 years of age and willing and able to provide informed consent.
    - Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features.
    - Consent to a fresh tumor biopsy before enrollment unless adequate archival tissue is available for molecular analyses. Consent to blood sample collection for germline DNA and biomarker analysis is required.
    •If the patient does not have a prior histologic diagnosis, a baseline fresh tumor biopsy may be used for both the purpose of confirming the histologic diagnosis and for biomarker analysis.
    • Sponsor preapproval is required when a biopsy procedure is needed for the sole purpose of determining study eligibility. Biopsies of the lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel may not be performed for the sole purpose of determining study eligibility.
    - A genomic defect in a DNA repair gene that is likely to or that may sensitize to PARP inhibition as assessed by a gene mutation biomarker panel.
    - Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
    - Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).
    - Progressive disease at study entry defined as 1 or more of the following 3 criteria:
    • A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.
    • Soft tissue disease progression as defined by RECIST 1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
    - Metastatic disease with measurable soft tissue disease by CT or MRI per RECIST 1.1. Patients with disease spread limited to regional pelvic lymph nodes (below the aortic bifurcation) are not eligible. Patients may also have metastatic disease documented by bone lesions on whole body radionuclide bone scan.
    - Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
    - A history of disease progression during previous treatment for metastatic CRPC with at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) in the opinion of the investigator.
    -Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
    - ECOG performance status of 0 to 2.
    -Estimated life expectancy of ≥ 6 months.
    -Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
    -Must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
    -Must agree not to donate sperm from the first dose of study drug to 105 days after the last dose of study drug.
    1. Tener al menos 18 años de edad y estar dispuesto y capacitado para otorgar su consentimiento informado.
    2. Adenocarcinoma de la próstata histológica o citológicamente confirmado sin características de diferenciación neuroendocrina, de células en anillo de sello o microcíticas.
    3. Dar el consentimiento para una biopsia de tumor nueva previa a la inscripción a menos que haya tejido de archivo disponible adecuado para los análisis moleculares. Se requiere dar el consentimiento para la extracción de una muestra de sangre para el análisis del ADN de la estirpe germinal y de biomarcadores.
     Si el paciente no cuenta con un diagnóstico histológico previo, se puede emplear una biopsia inicial nueva del tumor para confirmar el diagnóstico histológico y para el análisis de biomarcadores.
     Se requiere la aprobación previa del promotor cuando se precise de un procedimiento de biopsia con el único fin de determinar la aptitud para el estudio. No se pueden realizar biopsias del pulmón/mediastino, páncreas ni procedimientos endoscópicos que se extiendan más allá del esófago, estómago o intestino con el único objetivo de determinar la aptitud para el estudio.
    4. Un defecto genómico en un gen de reparación del ADN que es probable o que puede que sensibilice la inhibición de la PARP según la evaluación de un conjunto de biomarcadores de mutación génica (Anexo 2).
    5. Testosterona en suero ≤1,73 nmol/l (50 ng/dl) durante la selección.
    6. Orquiectomía bilateral o tratamiento continuo de privación de andrógenos con una hormona de liberación de gonadotropina (GnRH) que sea agonista/antagonista (castración médica o quirúrgica).
    7. Progresión de la enfermedad en el momento de incorporación al estudio definida por 1 o más de los siguientes 3 criterios:
     Un mínimo de 3 valores en aumento del PSA con un intervalo de, al menos, 1 semana entre las determinaciones. El valor del PSA del laboratorio central en la selección debe ser ≥2 μg/l (2 ng/ml) si se tiene únicamente en cuenta la progresión del PSA.
     Progresión de la enfermedad de partes blandas según lo definido por los criterios RECIST 1.1.
     Progresión de la enfermedad metastásica ósea según lo definido por el PCWG3 con 2 o más lesiones metastásicas nuevas en la gammagrafía ósea.
    8. Cáncer metastásico con cáncer de partes blandas medible mediante TAC o RM según RECIST 1.1. Los pacientes con diseminación del cáncer limitada a ganglios linfáticos pélvicos locales (por debajo de la bifurcación aórtica) no son aptos para el estudio. Los pacientes también pueden documentar el cáncer metastásico por lesiones óseas en una gammagrafía ósea del cuerpo completo.
    Spanish translation of MDV3800-06_Protocol Synopsis Version 1.0 dated on 1Jun2016
    9. Tratamiento previo con 1 o 2 pautas de quimioterapia entre las que se incluya, al menos, 1 pauta basada en taxanos para el cáncer de próstata metastásico. Los pacientes pueden haber recibido un tratamiento de radio-223 y/o cabazitaxel, o bien pudieron considerarse no aptos, rechazados o no tuvieron acceso a tales tratamientos.
    10. Antecedentes de la progresión de la enfermedad durante el tratamiento previo para el CPRC metastásico con, al menos, 1 tratamiento hormonal nuevo (enzalutamida o acetato de abiraterona/prednisona) según considere el investigador.
    11. Las dosis de bifosfonatos o denosumab deben mantenerse estables durante, al menos, 4 semanas antes del día 1 de la administración de dichos tratamientos para los pacientes.
    12. Estado general de 0 a 2 según el ECOG.
    13. Esperanza de vida estimada ≥6 meses.
    14. Capacidad de tragar el fármaco del estudio, sin intolerancia conocida a los fármacos o excipientes del estudio y cumplimiento con los requisitos para el mismo.
    15. Se debe utilizar el preservativo a la hora de tener relaciones sexuales con una mujer embarazada o con una mujer en edad fértil desde el momento de la toma de la primera dosis del fármaco del estudio hasta los 105 días posteriores a la última dosis. Se debe considerar el uso de un método anticonceptivo para una pareja femenina en edad fértil que no esté embarazada.
    16. Los pacientes no deben donar esperma a partir de la primera dosis del fármaco del estudio y hasta 105 días después de la última dosis.
    E.4Principal exclusion criteria
    - Use of systemic hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
    - Prior treatment with a PARP inhibitor, platinum, cyclophosphamide, or mitoxantrone chemotherapy.
    - Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
    - Major surgery within 2 weeks before day 1.
    - Clinically significant cardiovascular disease, including any of the following:
    • Myocardial infarction or symptomatic cardiac ischemia within 6 months before screening.
    • Congestive heart failure New York Heart Association class III or IV.
    History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes).
    • History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place.
    • Hypotension as indicated by systolic blood pressure < 86 mm Hg at screening.
    • Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram.
    • Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening.
    - Significant organ dysfunction as defined by the following laboratory abnormality:
    • Renal: eGFR < 30 mL/min /1.73 m2 by the MDRD equation (Modification of Diet in Renal Disease [available via www.mdrd.com]).
    • Hepatic:
    – Total serum bilirubin > 1.5 times the upper limit of normal (ULN) (> 3 times ULN for patients with Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation)
    – Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times ULN (if liver test abnormalities are due to hepatic metastasis, then AST or ALT ≥ 5 × ULN)
    – Albumin < 3.0 g/dL
    • Bone marrow reserve: absolute neutrophil count < 1500/μL, platelets < 100,000/μL, or hemoglobin < 9 g/dL (NOTE: may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).
    - Known or suspected brain metastasis or active leptomeningeal disease.
    - Symptomatic or impending spinal cord compression or cauda equina syndrome.
    - Diagnosis of MDS.
    - History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
    - Gastrointestinal disorder affecting absorption.
    - Current or anticipated use of a strong P-gp inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P-gp inducer (eg, rifampin, tipranavir, ritonavir), or strong inhibitor of BCRP (eg, elacridar [GF120918]).
    - Any other condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
    1. Utilización de un tratamiento hormonal, biológico o de radioisótopos para tratar el cáncer de próstata metastásico (que no se trate de fármacos dirigidos a los huesos ni agonista/antagonista de la GnRH) o cualquier otro fármaco en investigación durante las 4 semanas previas al día 1 del estudio.
    2. Tratamiento previo con un inhibidor de la PARP, un derivado del platino, ciclofosfamida o quimioterapia de mitoxantrona.
    3. Radioterapia durante las 3 semanas previas (2 semanas si se trató de una única fracción de radioterapia) antes del día 1 del estudio.
    4. Cirugía mayor durante las 2 semanas previas al día 1 del estudio.
    5. Enfermedad cardiovascular clínicamente significativa, incluidos los siguientes casos:
     Infarto de miocardio o isquemia cardiaca sintomática durante los 6 meses previos a la selección.
     Insuficiencia cardiaca congestiva de clase III o IV según la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA).
    Antecedentes de arritmias ventriculares clínicamente significativas (p. ej., taquicardia ventricular sostenida, fibrilación ventricular, torsade de pointes [taquicardia ventricular en entorchado]).
     Antecedentes de bloqueo auriculoventricular de tercer o segundo grado Mobitz II a menos que tenga un marcapasos permanente colocado.
     Hipotensión, según indica la tensión arterial sistólica <86 mm Hg en la selección.
     Bradicardia según indica una frecuencia cardiaca de <45 latidos por minuto en el electrocardiograma de la selección.
     Hipertensión no controlada según indica una tensión arterial sistólica >170 mm Hg o una tensión arterial diastólica >105 mm Hg en la selección.
    6. Una disfunción orgánica significativa que venga definida por alguna de las siguientes anomalías analíticas:
     Renal: TFGe < 30 ml/min /1,73 m2 según la ecuación de MDER (modificación de la dieta en la enfermedad renal disponible en www.mdrd.com).
     Hepática:
    - Bilirrubina sérica total > 1,5 veces el límite superior de la normalidad (LSN) (>3 veces el LSN para pacientes con síndrome de Gilbert o para aquellos con concentraciones de bilirrubina indirecta que sugieran que existe una fuente extrahepática de elevación).
    - Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ≥ 2,5 veces el LSN (si las anomalías analíticas hepáticas se deben a metástasis hepáticas, entonces AST o ALT ≥ 5 × LSN).
    – Albúmina < 3,0 g/dl.
     Reserva de la médula ósea: recuento absoluto de neutrófilos < 1500/μl, plaquetas < 100 000/μl o hemoglobina < 9 g/dl (NOTA: el paciente no debe haber recibido factores de crecimiento ni transfusiones de sangre en los 14 días previos a la obtención de los valores hematológicos en la selección).
    7. Metástasis cerebral conocida o sospecha de la misma, o enfermedad leptomeníngea activa.
    8. Compresión sintomática o inminente de la médula espinal, o síndrome de la cola de caballo.
    9. Diagnóstico de SMD.
    10. Antecedentes de otros cánceres en los 3 años previos a la inscripción, con la excepción de carcinomas cutáneos de tipo no melanoma o tumores en la fase 0 o fase 1 según la Comisión Conjunta Estadounidense sobre el Cáncer (American Joint Committee on Cancer), que tienen posibilidades remotas de recurrencia desde el punto de vista del investigador o el promotor.
    11. Trastorno gastrointestinal que afecte a la absorción.
    12. Utilización actual o esperada de un inhibidor potente de la gp-P (por ejemplo, dronedarona, quinidina, ranolazina, itraconazol, ketoconazol), un inductor potente de la gp-P (por ejemplo, rifampina, tipranavir, ritonavir) o un inhibidor potente de BCRP (por ejemplo, elacridar [GF120918]).
    13. Cualquier otra afección (enfermedad concurrenteconcurrente, infección o comorbilidad) que interfiera en la capacidad del paciente para participar en el estudio, cause un riesgo indebido o complique la interpretación de los datos, desde el punto de vista del investigador o el supervisor médico.
    E.5 End points
    E.5.1Primary end point(s)
    Best objective response rate (ORR)
    Mejor tasa de respuesta objetiva (TRO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint analysis will be performed when the last enrolled patient completes at least 6 months of study drug treatment, withdraws consent, discontinues from the study, or dies, whichever occurs first.
    El análisis primario se llevará a cabo cuando el último pacietne reclutado complete al menos 6 meses de tratamiento de medicamente del ensayo, retire su consentimiento, se descontinúe del ensayo o muera, lo que primero ocurra.
    E.5.2Secondary end point(s)
    • Time to objective response
    • Duration of response
    Tiempo de respuesta objetiva
    Duración de respuesta
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Time to objective response: time from enrollment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3.
    • Duration of response: time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST 1.1 by independent central review and no evidence of confirmed bone disease progression per PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurs first.
    Tiempo hasta la respuesta objetiva: el tiempo desde la inscripción hasta la primera prueba objetiva de respuesta en las partes blandas sin que haya signos de confirmación de la progresión de la enfermedad metastásica ósea en la gammagrafía ósea según el PCWG3.
    Duración de la respuesta: el tiempo desde la primera prueba objetiva de respuesta de las partes blandas (confirmada posteriormente) según RECIST 1.1 mediante una revisión central independiente y sin que haya signos de confirmación de la progresión de la enfermedad metastásica ósea según el PCWG3 hasta la siguiente prueba objetiva de progresión radiográfica o la muerte por cualquier causa, lo que ocurra primero.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory biomarker assessments: Sufficient fresh or archival tumor tissue must be submitted at prescreening (optional) or screening for whole exome sequencing, homologous recombination deficiency (HRD) analysis, and transcriptome studies. Blood samples for germline DNA sequencing will be collected at prescreening (optional) or screening. Blood samples for circulating tumor cells (CTC), circulating tumor DNA (ctDNA), and protein biomarker analyses will be collected throughout the study.
    Eval. de biomarcadores:cantidad suf. de tejido tumoral nuevo o archivo en la preselección (opcional) o en selección para secuenciac. del exoma completo, análisis de deficiencia de recombinación homóloga (DRH) y estudios del transcriptoma.Obtención muestras de sangre para secuenciac. de ADN de la estirpe germinal en la preselección (opcional) o en selección; Muestras para análisis de CTC, ADN tumoral circulante (ADNtc) y biomarca. proteicos durante el estudio.Habrá evaluaciones generales y analít
    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 Yes
    E.8.1.7.1Other trial design description
    Cohortes que se cruzan
    Overlapping cohorts
    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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    New Zealand
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP
    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 months7
    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 months7
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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)
    None
    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 Decision2016-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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