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    Summary
    EudraCT Number:2014-004010-28
    Sponsor's Protocol Code Number:I3Y-MC-JPBO(a)
    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:2015-10-26
    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 number2014-004010-28
    A.3Full title of the trial
    A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma
    Estudio de fase 2 de Abemaciclib en pacientes con metástasis cerebrales secundarias a cáncer de mama con receptores hormonales positivos, cáncer de pulmón no microcítico o melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-Small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
    Estudio de Abemaciclib (LY2835219) en pacientes con cancer de mama, cancer de pulmón no microcítico, o melanoma que se ha extendido al cerebro
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBO(a)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02308020
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointMaria Pilar Lopez
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916231218
    B.5.5Fax number003491663 34 81
    B.5.6E-maillopez_maria_pilar@lilly.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 nameAbemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1231929-97-7
    D.3.9.3Other descriptive nameLY2835219
    D.3.9.4EV Substance CodeSUB88440
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Brain tumors, Breast Cancer
    Tumor cerebral, Cancer de mama
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cancer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 this study is to evaluate abemaciclib with respect to OIRR (complete response [CR] + partial response [PR]) based on tumor assessments and Response Assessment in Neuro-Oncology brain metastases response assessment criteria (RANO-BM):
    ? in patients with brain metastases secondary to HR+, HER2+ breast cancer.
    ? in patients with brain metastases secondary to HR+, HER2- breast cancer.
    ? in patients with brain metastases secondary to NSCLC.
    ? in patients with brain metastases secondary to melanoma.
    El objetivo principal de este estudio es evaluar abemaciclib en relación con la TRIO (respuestas completas [RC] + respuestas parciales [RP]), basándose en las evaluaciones tumorales realizadas y en los Criterios de evaluación de la respuesta de metástasis cerebrales en neurooncología (RANO-BM):
    -En pacientes con metástasis cerebrales secundarias a cáncer de mama HR+ y HER2+.
    -En pacientes con metástasis cerebrales secundarias a cáncer de mama HR+ y HER2-.
    -En pacientes con metástasis cerebrales secundarias a CPNM.
    -En pacientes con metástasis cerebrales secundarias a melanoma
    E.2.2Secondary objectives of the trial
    Evaluate abemaciclib with respect to:
    - Intracranial disease per RANO-BM
    - Best overall intracranial response (BOIR)
    - Duration of intracranial response (DOIR) (CR + PR)
    - Intracranial disease control rate (IDCR) (CR + PR + stable disease [SD])
    - Intracranial clinical benefit rate (ICBR) (CR + PR + SD ?6 months)
    Overall
    - Overall survival (OS)
    - Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and RANO-BM
    - Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1 and RANO-BM
    - Progression free survival (PFS) per RECIST v1.1 and RANO-BM
    - Change in symptoms as assessed by MD Anderson Symptom Inventory ? Brain Tumor (MDASI-BT)
    - Safety and tolerability
    - PK of abemaciclib and its metabolites
    Los objetivos secundarios del estudio son evaluar abemaciclib en relación con los siguientes parámetros: Enfermedad intracraneal, de acuerdo con los criterios RANO-BM.Mejor respuesta intracraneal global (MRIG)-Duración de la respuesta intracraneal (DDRI) (RC + RP)-Tasa de control de la enfermedad intracraneal (TCEI) (RC + RP + enfermedad estable [EE])-Tasa de beneficio clínico intracraneal (TBCI) (RC + RP + EE ? 6 meses)?Global -Supervivencia global (SG)-Tasa de respuestas objetivas (TRO) de acuerdo con los Criterios para la evaluación (RECIST) v1.1 y los criterios RANO-BM.-Tasa de control de la enfermedad (TCE) (RC + RP + EE), de acuerdo con los criterios RECIST v1.1 y los criterios RANO-BM -Supervivencia sin progresión (SSP), de acuerdo con los criterios RECIST v1.1 y los criterios RANO-BM ?Cambios en los síntomas, de acuerdo con el Inventario de síntomas del M.D. Anderson ? Tumor cerebral (MDASI-BT) ?Seguridad y tolerabilidad ?FC de abemaciclib y sus metabolitos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] have brain metastases secondary to histologically or cytologically confirmed HR+ breast cancer, NSCLC, or melanoma.
    For Parts A and B: have confirmed HR+ breast cancer. To fulfill the requirement for HR+ disease, a breast cancer must express, at least 1 of the hormone receptors (ER or progesterone receptor [PgR]). For ER and PgR assays to be considered positive, ?1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC) (Hammond et al. 2010).
    For Part A: have HR+ breast cancer with confirmed HER2 overexpression (HER2+) status. To fulfill the requirement for HER2+ disease, tumor tissue must demonstrate 3+ by IHC or gene amplification by in-situ hybridization (ISH) (Wolff et al. 2013).
    For Part B: have HR+ breast cancer which does not demonstrate HER2 overexpression (HER2-) by either IHC or ISH.
    For Part C: have HR+ breast cancer, NSCLC, or melanoma with brain lesions for which surgical resection is clinically indicated and agree to provide posttreatment (5 to 14 days after initiating abemaciclib) brain tumor tissue.
    For Part D: have NSCLC of any subtype. Patients must have known KRAS mutation status by local test. If unknown or not done, whole block, partial block, or unstained slides must be available for submission.
    For Part E: have melanoma of any subtype
    For Part F: have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases by documented positive CSF cytology or by clinical signs and symptoms associated with abnormal magnetic resonance imaging (MRI) features. Concomitant parenchymal brain metastases are allowed (not required), but must be stable for at least 4 weeks following whole brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS).
    [2] Deleted criterion.
    [3] For Parts A,B, D and E: have ?1 new or not previously irradiated measurable metastatic brain lesion ?10 mm in the longest diameter (LD) or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd MRI).
    For Part C (surgical): have metastatic brain lesion(s) for which surgical resection is clinically indicated.
    [4] have completed local therapy (surgical resection, WBRT, or SRS) ?14 days prior to initiating abemaciclib and recovered from all acute effects. Patients are not required to have received prior local therapy for study participation.
    [5] if receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
    [6] have a Karnofsky performance status of ?70 (see Attachment 4).
    [7] have a life expectancy ?12 weeks.
    [8] for HR+ breast cancer patients in Parts A, B, C, and F: if currently receiving endocrine therapy, a patient may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and CNS disease progression has occurred while on this endocrine therapy. If these conditions are not met, patients must discontinue endocrine therapy prior to initiation of abemaciclib.
    For HER2+ breast cancer patients in Parts A, C, and F: patients may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with intravenous (IV) trastuzumab. Concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.
    For NSCLC patients in Parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a patient may continue to receive 1 of these 2 therapies as a single agent provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy. Combination therapies (aside from gemcitabine or pemetrexed) must be discontinued for at least 14 days prior to initiation of abemaciclib.
    [9] have discontinued all previous therapies for cancer (including cytotoxic chemotherapy, targeted therapy [including, but not limited to, everolimus], radiotherapy, immunotherapy, and investigational therapy) for at least 14 days prior to receiving abemaciclib and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia or peripheral neuropathy.
    [10] for HER2+ breast cancer patients in Parts A, C, and F: patients receiving concurrent IV trastuzumab, must have left ventricular ejection fraction within investigative site?s normal range.
    Los pacientes se considerarán idóneos para participar en el estudio únicamente si cumplen todos los criterios que se detallan a continuación: [1]Presentar metástasis cerebrales secundarias a cáncer de mama HR+, CPNM o melanoma, confirmadas histológica o citológicamente. En relación con las partes A y B: presentar cáncer de mama HR+ confirmado. Para cumplir el requisito de presentar enfermedad en la que se expresen receptores hormonales (HR+), en el cáncer de mama debe expresarse al menos 1 de los receptores hormonales (receptor estrogénico [ER] o receptor de la progesterona [PgR]). Para que los resultados de los ensayos del ER y del PgR se consideren positivos, ? 1% de los núcleos de las células tumorales deben ser inmunorreactivos según los resultados de las pruebas de inmunohistoquímica (IHQ) (Hammond et al., 2010). En relación con la parte A: presentar cáncer de mama HR+ con sobreexpresión confirmada del HER2 (HER2+). Para cumplir el requisito de presentar enfermedad con sobreexpresión del HER2, el tejido tumoral debe mostrar un resultado ?3+? en las pruebas de IHQ o en la amplificación génica realizada mediante hibridización in situ (ISH) (Wolff et al., 2013). En relación con la parte B: tener cáncer de mama HR+ sin sobreexpresión del HER2 (HER2-), de acuerdo con pruebas de IHQ o ISH. En relación con la parte C: tener cáncer de mama HR+, CPNM o melanoma con lesiones cerebrales para las que esté clínicamente indicado realizar una resección quirúrgica y estar de acuerdo en proporcionar tejido del tumor cerebral después del tratamiento (entre 5 y 14 días después del inicio de la administración de abemaciclib).En relación con la parte D: tener CPNM de cualquier subtipo. Los pacientes deben presentar mutaciones en el gen KRAS según las pruebas realizadas localmente. En caso de que se desconozca si el paciente presenta mutaciones o si esta prueba no se ha realizado, debe disponerse de bloques completos o parciales o secciones sin teñir.

    En relación con la parte E: tener melanoma de cualquier subtipo.
    En relación con la parte F: tener cáncer de mama HR+, CPNM o melanoma con metástasis leptomeníngeas, de acuerdo con los resultados positivos y documentados de una citología del LCR o los signos y síntomas clínicos asociados con imágenes anómalas en la resonancia magnética nuclear (RMN). Si bien se permite la presencia concomitante de metástasis cerebrales parenquimatosas (aunque no es un requisito), estas deben haber permanecido estables al menos durante las 4 semanas posteriores a la radioterapia total del cerebro (RDTC) o a la radiocirugía estereotáctica (RCE).[2]Criterio eliminado.
    [3]En relación con las partes A y B: presentar ? 1 lesión cerebral metastásica mensurable (bien nueva o a la que no se haya administrado radioterapia) cuyo diámetro mayor (DM) mida ? 10 mm o una lesión cerebral metastásica que haya sido irradiada y presente progresión, de acuerdo con los resultados radiológicos de una resonancia magnética nuclear con gadolinio (RMN-Gd).
    En relación con la parte C (quirúrgica): presentar una o varias lesiones cerebrales metastásicas para las que esté clínicamente indicado realizar una resección quirúrgica.
    [4]Haber completado un tratamiento local (resección quirúrgica, radioterapia total del cerebro [RTC] o radiocirugía estereotáctica [RCE]) ? 14 días antes del inicio del tratamiento con abemaciclib y haberse recuperado de todos los efectos inmediatos. No se requiere que los pacientes hayan recibido anteriormente tratamiento local para participar en el estudio.
    [5]En caso de estar recibiendo corticosteroides, debe estar administrándose una dosis estable o decreciente al menos durante los 7 días previos a la RMN-Gd que se realizará durante el período basal.
    [6]Presentar una categoría funcional de Karnofsky ? 70 (véase el anexo 4).
    [7]Tener una esperanza de vida ? 12 semanas
    [8]En relación con los pacientes con cáncer de mama HR+ que participen en las partes A, B, C y F: si el paciente está recibiendo en la actualidad hormonoterapia, podrá continuar con la misma hormonoterapia, siempre que la enfermedad extracraneal haya permanecido estable al menos durante 3 meses y la progresión de la enfermedad en el SNC se haya producido mientras recibía la hormonoterapia. Si no se cumplen estos requisitos, los pacientes deben interrumpir definitivamente la hormonoterapia antes de iniciar la administración de abemaciclib.
    En relación con los pacientes con cáncer de mama HER2+ que participen en las partes A, C y F: los pacientes pueden recibir tratamiento concurrente (en curso o que se haya iniciado simultáneamente a la administración de abemaciclib) con trastuzumab por vía intravenosa (i.v.). No se permite la administración concurrente de tratamiento con trastuzumab emtansina (T-DM1).

    (Por favor, por cuestiones de espacio no se ha podido incluir todo, diriganse a la sección del protocolo de criterios de inclusion)
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [16] require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
    [17] require concurrent anticancer treatment at any time during the study treatment period.
    [18] are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
    [19] have evidence of significant (ie, symptomatic) intracranial hemorrhage.
    [20] for Parts A, B, C, D, and E: have evidence of leptomeningeal metastases by clinical signs and symptoms associated with abnormal MRI features or by documented CSF cytology.
    [21] have experienced >2 seizures within 4 weeks prior to study entry.
    [22] have visceral crisis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
    [23] for Parts A, B, D, E, and F: have previously received treatment with any CDK4 and CDK6 inhibitor. Part C patients may have received prior palbociclib or ribociclib, but not abemaciclib, treatment.
    [24] have known contraindication to Gd-MRI.
    [25] deleted criterion.
    [26] are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [27] have received treatment with a drug that has not received regulatory approval for any indication within 14 days of the initial dose of abemaciclib.
    [28] have a personal history within the last 12 months of any ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest.
    [29] have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel).
    [30] have a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea.
    [31] have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
    [32] are lactating.
    [33] have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrollment.
    [34] have an acute bacterial infection requiring IV antibiotics.
    [35] have received recent (within 28 days of initial dose of abemaciclib) or concurrent yellow fever vaccination.
    Se excluirá del estudio a los pacientes en los que se constate alguno de los criterios siguientes:
    [[16]Requerir la administración inmediata de tratamiento local, entre otros, radioterapia total del cerebro (RTC), radiocirugía estereotáctica (RCE) o resección quirúrgica para el tratamiento de las metástasis cerebrales
    [17]Requerir la administración concurrente de tratamiento antineoplásico en cualquier momento del período de tratamiento del estudio.

    [18]Estar recibiendo tratamiento concurrente con fármacos antiepilépticos que provocan inducción enzimática (FAEIE).
    [19] Presentar signos de hemorragia intracraneal significativa (esto es, sintomática).
    [20]En relación con las partes A, B, C, D y E: presentar signos de metástasis leptomeníngeas (de acuerdo con los signos y síntomas clínicos asociados con imágenes anómalas en la RMN o con una citología documentada del LCR).

    [21]Haber experimentado > 2 convulsiones en el transcurso de las 4 semanas anteriores a la inclusión en el estudio.
    [22]Tener crisis visceral. Por ?crisis visceral? no se entiende simplemente la mera presencia de metástasis viscerales, sino que implica una disfunción orgánica significativa, de acuerdo con los síntomas y signos, las pruebas analíticas y la rápida progresión de la enfermedad.
    [23]En relación con las partes A, B, D, E y F: haber recibido anteriormente tratamiento con cualquier inhibidor de la CDK4 o la CDK6. Los pacientes que participen en la parte C pueden haber recibido tratamiento con palbociclib o ribociclib, no así con abemaciclib.
    [24]Presentar una contraindicación a la RMN-Gd.
    [25]Criterio eliminado.
    [26]Estar participando en la actualidad en un ensayo clínico en el que se administre un producto en fase de investigación o se haga un uso no recogido en la ficha técnica de un fármaco o producto sanitario (salvo el fármaco en estudio durante este ensayo), o estar participando en la actualidad en cualquier otro tipo de investigación médica que se considere que no es compatible con el estudio, desde un punto de vista científico o médico.
    [27]Haber recibido tratamiento con un fármaco que no haya recibido la autorización de las autoridades sanitarias para ninguna indicación en el transcurso de los 14 días previos a la dosis inicial de abemaciclib.
    [28]Tener antecedentes personales de cualquier arritmia ventricular (entre otras, taquicardia ventricular y fibrilación ventricular) o paro cardiaco súbito, en el transcurso de los últimos 12 meses.
    [29]Presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir la participación en este estudio (por ejemplo, antecedentes de resección quirúrgica mayor del estómago o el intestino delgado).
    [30]Tener una enfermedad crónica preexistente que provoque que el paciente presente durante el período basal diarrea de grado ? 2.
    [31]Presentar antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ del cuello uterino), a menos que haya estado en remisión completa al menos durante 3 años, sin ningún tipo de tratamiento.
    [32]Estar en período de lactancia.
    [33]Tener micosis sistémica activa o infección vírica (por ejemplo, anticuerpos frente al virus de la inmunodeficiencia humana [VIH], el antígeno de superficie del virus de la hepatitis B o anticuerpos frente al virus de la hepatitis C). No es necesario realizar pruebas de detección para el reclutamiento del paciente.
    [34]Tener una infección bacteriana aguda que requiera la administración de antibióticos por vía i.v.
    [35]Haber recibido recientemente (en el transcurso de los 28 días previos a la dosis inicial de abemaciclib) o de forma concomitante una vacuna contra la fiebre amarilla
    E.5 End points
    E.5.1Primary end point(s)
    Objective Intracranial Response Rate (OIRR) assessed using RANO-BM
    El criterio principal de valoración de este estudio es la Tasa de Respuestas Intracraneales Objetivas (TRIO), de acuerdo con los criterios RANO-BM
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Objective Disease Progression (Approximately 6 Months)
    Periodo basal haya progresión objetiva de la enfermedad (Aproximadamente 6 meses)
    E.5.2Secondary end point(s)
    Best Overall Intracranial Response (BOIR)
    Duration of intracranial response (DOIR) (CR + PR)
    Intracranial disease control rate (IDCR)
    Intracranial Clinical Benefit Rate (ICBR)
    Overall Survival (OS)
    Objective Response Rate (ORR)
    Disease Control Rate (DCR)
    Progression Free Survival (PFS)
    Change from Baseline to End of Study in Neurologic Symptoms on the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Scale
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Abemaciclib and its Metabolites
    Mejor respuesta intracraneal global (MRIG)
    Duración de la respuesta intracraneal (DDRI) (RC + RP)
    Tasa de control de la enfermedad intracraneal (TCEI)
    Tasa de beneficio clínico intracraneal (TBCI)
    Supervivencia global (SG)
    Tasa de respuestas objetivas (TRO), de acuerdo con los criterios RECIST v1.1 y los criterios de respuesta de las metástasis cerebrales
    Tasa de control de la enfermedad (TCE)
    Supervivencia sin progresión (SSP)
    Cambio desde la visita basal hasta el final del estudio de los síntomas neurológicos del inventario de síntomas del M.D. Anderson ? Escala de Tumor Cerebral (MDASI-BT)
    Farmacocinética (FC): Concentración Mínima (Cmin) de Abemaciclib y sus metabolites
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Approximately 6 Months)- Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death from Any Cause (Approximately 6 Months) -Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months) -Baseline to Death from Any Cause (Approximately 18 Months)- Baseline to Disease Progression (Approximately 6 Months) Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months) Baseline to Objective Disease Progression or Death from Any Cause (Approximately 6 Months) Baseline, End of Study (Approximately 6 Months)
    Cycle 1 through Cycle 4 (Approximately 3 Months)
    Desde Periodo basal hasta progresión objetiva de la enfermedad o comienzo de un nuevo tratamiento antineoplásico (Aprox. 6 meses). Desde la Fecha de Respuesta Completa o Respuesta Parcial hasta fecha de progresión objetiva de la enfermedad o muerte por cualquier causa (aprox. 6 meses).Desde Periodo Basal hasta progresión de la enfermedad o el comienzo de nuevo tratamiento antineoplásico (aprox. 6 meses).Desde periodo basal hasta muerte por cualquier causa (aprox. 18 meses).Desde Periodo basal hasta progresión de la enfermedad (aproximadamente 6 meses).Desde el periodo basal hasta la progresión objetiva de la enfermedad o muerte por cualquier causa (aproximadamente 6 meses) Periodo basal, finalización del estudio (aproximadamente 6 meses).Ciclo 1 a ciclo 4 (aproximadamente 3 meses)
    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 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.8.2.4Number of treatment arms in the trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Austria
    Belgium
    Canada
    France
    Israel
    Italy
    New Zealand
    Spain
    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
    End of trial refers to the date of the last visit or last scheduled procedure for the last patient. The end of trial occurs after study completion and after the last patient has discontinued study treatment and completed any applicable continued access follow-up
    El final del ensayo es la fecha de la última visita o del último procedimiento programado, para el último paciente. El final del ensayo se producirá con posterioridad a la finalización del estudio y después de que el último paciente haya interrumpido el tratamiento del estudio y haya completado cualquier período de seguimiento correspondiente al período de acceso continuado
    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 months3
    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 months3
    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: 149
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 247
    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)
    Post-treatment discontinuation follow up starts just after the last dose of study drug and ends when final safety assessments are completed 30 days (±5) after last dose of study drug. Long term follow up begins after the day short term post discontinuation follow up visits is completed and continues until the patient?s death, lost to follow-up, or overall study completion.
    La discontinuación tras el tto. del estudio comienza justo después de la última dosis de la medicación del estudio y finaliza cuando la evaluación final de seguridad se haya completado 30 días (±5) después de la última dosis de la medicación del estudio.El período de seguimiento a largo plazo comienza el día después de que finalice el período de seguimiento a corto plazo y continúa hasta el fallecimiento del paciente, pérdida de seguimiento del paciente o hasta la finalización global del estudio
    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 Decision2015-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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