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    Summary
    EudraCT Number:2016-000288-18
    Sponsor's Protocol Code Number:I3Y-MC-JPCG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-24
    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 number2016-000288-18
    A.3Full title of the trial
    A Randomized, Open-Label, Phase 2 Study of Abemaciclib plus Tamoxifen or Abemaciclib Alone, in Women with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Estudio de fase 2, aleatorizado, abierto, en el que se evalúa Abemaciclib con Tamoxifeno o Abemaciclib en monoterapia, en mujeres con cáncer de mama metastásico con receptores hormonales positivos y HER2 negativo que hayan recibido tratamiento previo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
    Estudio de abemaciclib y tamoxifeno o de abemaciclib en monoterapia en mujeres con cáncer de mama
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCG
    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 pointMaria Pilar López
    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 number003491623 12 18
    B.5.5Fax number003491623 12 18
    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.3.4Pharmaceutical 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 INNabemaciclib
    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.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 nameAbemaciclib
    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 INNabemaciclib
    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 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.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
    Breast cancer
    Cáncer de mama
    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 19.0
    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
    To evaluate the efficacy, in terms of Progression Free Survival (PFS), in patients with metastatic breast cancer for:
    •Abemaciclib 150 mg Q12H plus tamoxifen
    •Abemaciclib 150 mg Q12H
    •Abemaciclib 200 mg Q12H plus primary prophylactic loperamide
    Evaluar la eficacia, desde el punto de vista de la supervivencia sin progresión (SSP), en pacientes con cáncer de mama metastásico, de:
    • 150 mg de abemaciclib C12H y tamoxifeno
    • 150 mg de abemaciclib C12H
    • 200 mg de abemaciclib C12H y profilaxis primaria con loperamida
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of abemaciclib monotherapy and in combination with tamoxifen, in terms of Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS)
    •To assess the safety profile of abemaciclib monotherapy and in combination with tamoxifen
    •To characterize the PK of abemaciclib and its metabolites; in addition to tamoxifen and its active metabolite endoxifen
    •To compare self-reported evaluate impact on pain, pain interference, , disease symptom burdens, health status and overall quality of life
    • Evaluar la eficacia de abemaciclib en monoterapia y en combinación con tamoxifeno, desde el punto de vista de la tasa de respuestas objetivas (TRO), la duración de la respuesta (DdR) y la supervivencia global (SG).
    • Evaluar el perfil de seguridad de abemaciclib en monoterapia y en combinación con tamoxifeno.
    • Caracterizar la FC de abemaciclib y sus metabolitos, además de la de tamoxifeno y su metabolito activo endoxifeno.
    • Comparar el dolor, la interferencia del dolor, las cargas sintomáticas de la enfermedad, el estado de salud y la calidad de vida global, de acuerdo con la percepción del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Have a diagnosis of HR+, HER2- breast cancer
    •Relapsed or progressed following endocrine therapy
    •Have received prior treatment with at least 2 chemotherapy regimens, of which 1 but more than 2 have been administered in the metastatic setting
    •Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
    •Have a performance status ≤1 on the ECOG scale
    •Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy
    •Have adequate organ function
    •Have negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment
    •Are able to swallow oral medication
    • Tener un diagnóstico de cáncer de mama HR+, HER2-.
    • Haber experimentado recidiva o progresión de la enfermedad tras la hormonoterapia.
    • Haber recibido tratamiento con al menos 2 tratamientos quimioterápicos y al menos 1 de estos (pero no más de 2) debe haberse administrado para el cáncer metastásico.
    • Presentar enfermedad mensurable, de acuerdo con los Criterios de evaluación de la respuesta en tumores sólidos (RECIST, 1.1).
    • Presentar una categoría funcional ≤ 1 en la escala ECOG.
    • Haber interrumpido todos los tratamientos antineoplásicos previos, entre los que se incluyen específicamente los inhibidores de la aromatasa, los antiestrógenos y los tratamientos quimioterápicos, radioterápicos e inmunoterápicos, al menos 21 días (en el caso de los fármacos mielodepresores) o 14 días (en el caso de los fármacos que sin efecto mielodepresor) antes del inicio del tratamiento con el fármaco del estudio, y haberse recuperado de los efectos agudos de dichos tratamientos (esto es, la toxicidad deberá haber retornado a los valores basales o al menos a un grado 1) –excepto en el caso de la alopecia residual y la neuropatía periférica–.
    • Presentar una función orgánica aceptable.
    • Presentar un resultado negativo en una prueba de embarazo en suero que se realizará en el transcurso de los 7 días anteriores a la aleatorización y aceptar utilizar medidas anticonceptivas autorizadas desde el punto de vista médico, durante el estudio y las 12 semanas posteriores a la última dosis del tratamiento del estudio.
    • Ser capaz de ingerir medicamentos por vía oral.
    E.4Principal exclusion criteria
    •Have clinical evidence or history of central nervous system metastasis
    •Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
    •Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
    •Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
    •Have active bacterial or fungal infection, or detectable viral infection
    •Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor
    •Have a preexisting chronic condition resulting in persistent diarrhea
    •Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years
    • Presentar signos clínicos o antecedentes de metástasis en el sistema nervioso central.
    • Haber recibido tratamiento, en los 14 o 21 días anteriores a la aleatorización al fármaco del estudio, con un fármaco sin actividad mielodepresora o con efecto mielodepresor, respectivamente, que no haya recibido aprobación por parte de las autoridades sanitarias para ninguna indicación.
    • Haberse sometido a una intervención de cirugía mayor en el transcurso de los 14 días anteriores a la aleatorización al fármaco del estudio (para permitir la curación de la herida y la zona quirúrgica).
    • Presentar antecedentes personales de cualquiera de las siguientes enfermedades: presíncope o síncope de etiología inexplicable o etiología cardiovascular, taquicardia ventricular, fibrilación ventricular o paro cardiaco súbito.
    • Tener infección bacteriana o micosis activa, o infección vírica detectable.
    • Haber recibido tratamiento con un inhibidor de las cinasas 4 y 6 dependientes de ciclinas (CDK4/6).
    •Tener una enfermedad crónica preexistente que provoque diarrea persistente.
    •Presentar antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ de cuello uterino), a menos que haya estado en remisión completa al menos durante 3 años, sin ningún tipo de tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival: baseline to measured progressive disease or death from any cause
    Supervivencia sin progresión: tiempo transcurrido entre el período basal y la determinación de la progresión de la enfermedad o la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 14 months
    Aproximadamente 14 meses.
    E.5.2Secondary end point(s)
    •Percentage of participants achieving complete response (CR) or partial response (PR), time frame from baseline to objective disease progression: Objective Response Rate
    •Duration of CR and PR: Duration of Response
    •Overall Survival
    •Pharmacokinetics: mean steady state exposure of abemaciclib and its metabolites
    •Pharmacokinetics: mean steady state exposure of tamoxifen and endoxifen
    •Change from baseline to end of study in pain and symptom burden assessment on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
    •Change from baseline to end of study in pain and symptom burden assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
    •Porcentaje de participantes que alcancen una respuesta completa (RC) o una respuesta parcial (RP); tiempo transcurrido entre el período basal y la determinación de la progresión objetiva de la enfermedad: tasa de respuestas objetivas.
    • Duración de la RC y la RP: duración de la respuesta.
    • Supervivencia global.
    • Farmacocinética: media de la exposición en el estado de equilibrio a abemaciclib y sus metabolitos.
    • Farmacocinética: media de la exposición en el estado de equilibrio a tamoxifeno y endoxifeno.
    • Variación entre el período basal y el final del estudio en la evaluación del dolor y de la carga sintomática, de acuerdo con el Cuestionario de calidad de vida – Core 30 de la European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
    • Variación entre el período basal y el final del estudio en la evaluación del dolor y de la carga sintomática, de acuerdo con el Cuestionario breve modificado para la evaluación del dolor (mBPI-sf).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Baseline to objective disease progression (approximately 14 months)
    •Duration of CR and PR (approximately 14 months)
    •Overall survival (approximately 36 months)
    •Pharmacokinetics of abemaciclib and its metabolites, postdose cycle 1, day 1 through postdose cycle 3, day 1
    •Pharmacokinetics of tamoxifen and endoxifen, postdose cycle 1, day 1 through postdose cycle 3, day 1:
    •Change from baseline in pain and symptom burden assessment on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (approximately 14 months)
    •Change from baseline in pain and symptom burden assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) (approximately 14 months)
    •Tiempo entre período basal y determinación de progresión objetiva de enfermedad (aprox 14 meses)
    • Duración de RC y RP (aprox 14 meses)
    • Supervivencia global (aprox 36 meses)
    • Farmacocinética de abemaciclib y sus metabolitos, con posterioridad a la dosis del día 1 ciclo 1 y hasta después de la dosis del día 1 ciclo 3
    • Farmacocinética de tamoxifeno y endoxifeno, con posterioridad a la dosis del día 1 del ciclo 1 y hasta después de la dosis del día 1 del ciclo 3
    • Variación desde período basal en la evaluación del dolor y carga sintomática, de acuerdo con Cuestionario de calidad de vida – EORTC QLQ-C30 (aprox 14 meses)
    • Variación desde período basal en la evaluación del dolor y carga sintomática, de acuerdo con Cuestionario para evaluación del dolor (mBPI-sf) (aprox 14 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 Yes
    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 Yes
    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) Yes
    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 concerned7
    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
    Argentina
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Italy
    Mexico
    Russian Federation
    Spain
    Taiwan
    Turkey
    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
    Última visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days13
    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: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 225
    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 (±7) after last dose of study drug.

    Long term follow up begins after the day short term post discontinuation follow up visits are completed and continues until the patient’s death, patient is lost to follow-up, or overall study completion.
    Período seguimiento tras interrupción del tratamiento: comienza después de administración de última dosis del fármaco y finaliza cuando se completen evaluaciones de seguridad, 30(±7) días después de administración de última dosis del fármaco. Período seguimiento a largo plazo: comienza el día después de que se completen visitas de seguimiento a corto plazo tras interrupción del tratamiento y continúa hasta fallecimiento, hasta pérdida de seguimiento o hasta 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 Decision2016-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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