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    Summary
    EudraCT Number:2018-001853-28
    Sponsor's Protocol Code Number:I3Y-MC-JPCP
    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:2018-08-07
    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 number2018-001853-28
    A.3Full title of the trial
    An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability when Receiving Abemaciclib for Patients with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Estudio de fase 2 abierto y aleatorizado, en el que se evalúa cómo influyen los alimentos en la tolerabilidad de abemaciclib en pacientes con cáncer de mama metastásico con receptores hormonales positivos y HER2 negativos para el que hayan recibido tratamiento previo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Investigating the Impact of Food on Tolerability of Abemaciclib for Patients with Metastatic Breast Cancer
    Estudio en el que se evalúa cómo influyen los alimentos en la tolerabilidad de abemaciclib en pacientes con cáncer de mama metastásico
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCP
    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 States
    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 pointAna Arias
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number(+) 0034 91 6231251
    B.5.5Fax number(+) 0034 91 6633481
    B.5.6E-mailensayosclinicos@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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNabemaciclib
    D.3.9.1CAS number 1231929-97-7
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    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
    Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Cáncer de mama metastásico con receptores hormonales positivos y HER2 negativos para el que hayan recibido tratamiento previo
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cáncer 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast 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 and summarize incidence of severe diarrhea (≥Grade 3) or prolonged Grade 2 diarrhea (defined as >7 days duration), including the incidence of dose reductions, dose interruptions, and/or treatment discontinuations due to severe diarrhea or prolonged Grade 2 diarrhea over the first 3 cycles when abemaciclib is administered:
    • with a meal
    • without a meal, taken in the modified fasted condition
    • without regard to food
    Evaluar y resumir la incidencia de diarrea intensa (≥grado 3) o diarrea prolongada de grado 2 (>7 días de duración), es decir, la incidencia de las reducciones de dosis, las interrupciones de dosis o la interrupción del tratamiento por la presencia de diarrea intensa o diarrea prolongada de grado 2 durante los tres primeros ciclos, cuando abemaciclib se administra:
    • con una comida
    • sin una comida, en un estado de ayunas modificado
    • independientemente de las comidas
    E.2.2Secondary objectives of the trial
    To assess safety and toxicity profile of abemaciclib
    To evaluate the PK parameters of abemaciclib and its metabolites
    Evaluar la seguridad y el perfil de toxicidad de abemaciclib
    Evaluar los parámetros FC de abemaciclib y sus metabolites
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have a diagnosis of HR+, HER2− mBC
    Have all of the following:
    • Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
    • Prior treatment with chemotherapy for locally advanced or metastatic disease.
    • No prior treatment with CDK4 and CDK6 inhibitor.

    Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982)

    Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures, including keeping records in the electronic patient diary (e-diary) as required by study protocol.

    Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. All patients who experienced diarrhea as a side effect of previous therapy must have recovered to ≤Grade 1 prior to enrollment.
    Diagnóstico de CMm HR+, HER2-
    Satisfacer todos los criterios siguientes:
    • Presentar cáncer de mama recurrente, localmente avanzado, irresecable o metastásico, y haber mostrado progresión de la enfermedad con posterioridad al tratamiento con antiestrógenos.
    • Haber recibido tratamiento previo con quimioterapia para tratar el cáncer avanzado o metastásico.
    • No haber recibido tratamiento previo con inhibidores de la CDK4 y la CDK6.

    Presentar una categoría funcional (CF) ≤1 en la escala del Eastern Cooperative Oncology Group (ECOG) (Oken et al. 1982)

    Que pueda confiarse en el paciente y que esté dispuesto a estar disponible durante todo el estudio y a seguir los procedimientos de este, incluido el registro de información en el diario electrónico del paciente (diario-e), de conformidad con el protocolo del estudio.

    Haber dejado de recibir definitivamente todos los tratamientos antineoplásicos anteriores, y haberse recuperado de los efectos inmediatos del tratamiento. Todos los pacientes que hubieran presentado diarrea como un efecto secundario de un tratamiento anterior deben haberse recuperado hasta un grado ≤1 antes del reclutamiento.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    are currently receiving treatment in a clinical study involving an investigational product or are enrolled into any other type of medical research judged not to be scientifically or medically compatible with this study.
    have a serious concomitant systemic disorder (for example, active infection or a GI disorder causing clinically significant symptoms such as nausea, vomiting or diarrhea [such as Crohn’s disease, ulcerative colitis], or profound immune suppression) or a serious preexisting medical condition (for example, history of major surgical resection involving the stomach or small bowel) that, in the opinion of the investigator, would compromise/preclude the patient’s ability to adhere to the protocol.
    Se excluirá del estudio a los pacientes en los que se constate alguno de los siguientes criterios:
    •Estar participando en la actualidad en cualquier otro ensayo clínico en el que se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica que se considere incompatible con el estudio desde un punto de vista científico o médico.
    •Presentar un trastorno sistémico concomitante (por ejemplo, infección activa o un trastorno gastrointestinal que provoque síntomas clínicamente importantes como náuseas, vómitos o diarrea [como la enfermedad de Crohn, colitis ulcerosa] o inmunodepresión grave) o una enfermedad preexistente grave (por ejemplo, antecedentes de resección quirúrgica mayor con afectación del estómago o del intestino delgado) que, en opinión del investigador, ponga en riesgo o impida que el paciente cumpla el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of severe diarrhea (≥Grade 3)
    • Incidence of prolonged Grade 2 diarrhea (defined as >7 days duration)
    • Dose reductions due to diarrhea
    • Dose interruptions due to diarrhea
    • Treatment discontinuations due to diarrhea
    • Utilization of antidiarrheals (dose and duration)
    • Incidencia de diarrea intensa (≥grado 3)
    • Incidencia de diarrea prolongada de grado 2 (>7 días de duración)
    • Reducciones de la dosis por la presencia de diarrea
    • Interrupciones de la dosis por la presencia de diarrea
    • Interrupciones del tratamiento por la presencia de diarrea
    • Utilización de antidiarreicos (dosis y duración)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will record daily information on the number of stools, diarrhea, use of loperamide and the timing of the abemaciclib intake relative to their meals in cycle 1-3.
    Dose reductions and medications will be evalutaed throughout the study by the investigators.
    Los pacientes recogerán todos los días información sobre el número de deposiciones, la presencia de diarrea, el uso de loperamida y la hora en la que tomaron abemaciclib respecto a las comidas en los ciclos 1-3.
    Los investigadores evaluarán las reducciones de dosis y los medicamentos a lo largo del estudio.
    E.5.2Secondary end point(s)
    The safety endpoints evaluated will include, but are not limited to, the following:
    • Overall safety
    • incidence and severity of TEAEs, SAEs, deaths, and clinical laboratory abnormalities
    Steady state concentrations of abemaciclib and its metabolites LSN2839567 and LSN3106726
    Entre los criterios de valoración de la seguridad que se evaluarán se incluyen:
    • La seguridad global
    • La incidencia (y la intensidad) de los AAST y los AAG, de las muertes y los valores analíticos anómalos.
    • Las concentraciones en el estado de equilibrio de abemaciclib y sus metabolitos LSN2839567 y LSN3106726.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AE collection throughout study

    PK in cycles 1-3
    Recogida de la información relativa a los AA a lo largo de los análisis FC del estudio en los ciclos 1-3.
    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 No
    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 Yes
    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 trial3
    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 EEA5
    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
    Russian Federation
    Spain
    Turkey
    Ukraine
    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 the study is the date of the last visit or last scheduled procedure for the last patient.
    El «final del estudio» es la fecha de la última visita o del último procedimiento programado, para el último paciente.
    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 months4
    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 months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who are still on abemaciclib at the time of study completion may continue to receive abemaciclib in the continued-access period if they are experiencing clinical benefit and no undue risks.
    Los pacientes que aún estén recibiendo abemaciclib en el momento en el que finalice el estudio podrán continuar recibiéndolo durante el período de acceso continuado si están obteniendo beneficio clínico y no se identifica ningún riesgo excesivo.
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
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