Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-001502-18
    Sponsor's Protocol Code Number:I3Y-MC-JPBM
    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:2014-10-20
    Trial 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 number2014-001502-18
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
    Estudio de fase III aleatorizado, doble ciego, controlado
    con placebo, de Inhibidores de aromatasa no esteroideos
    (Anastrozol o Letrozol) en combinación con LY2835219 ?
    un inhibidor de CDK4/6 ?, o con placebo, en mujeres
    postmenopáusicas con cáncer de mama localmente
    recurrente o metastásico, con receptores hormonales
    positivos y HER2 negativo, no tratadas previamente con
    ninguna terapia sistémica para esta enfermedad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Nonsteroidal Aromatase Inhibitors Plus LY2835219 or Placebo in Postmenopausal Women With Breast Cancer
    Estudio de Inhibidores de aromatasa no esteroideos en combinación con LY2835219 ?un inhibidor de CDK4/6 ?, o con placebo, en mujeres postmenopáusicas con cáncer de mama
    A.3.2Name or abbreviated title of the trial where available
    Monarch 3
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBM
    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 organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number34916633473
    B.5.5Fax number34916633481
    B.5.6E-mailEU_Lilly_Clinical_Trials@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 nameLY2835219
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormone Receptor Positive, HER2 negative Locoregionally Recurrent or Metastatic Breast Cancer with No Prior Systemic Therapy in This Disease Setting
    Receptores hormonales positivos y HER2 negativo, en cáncer de mama localmente recurrente o metastásicono tratadas previamente con ninguna terapia sistémica para esta enfermedad
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer
    Cancer de mama metastasico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    The primary objective of Study I3Y-MC-JPBM is to compare treatment with LY2835219 plus NSAI therapy versus placebo plus NSAI therapy with respect to PFS in postmenopausal women with HR+, HER2- locoregionally recurrent or metastatic breast cancer who have not received prior systemic therapy in this disease setting.
    El objetivo principal del estudio I3Y-MC-JPBM es comparar el tratamiento con LY2835219 y un IANE con la administración de placebo y un IANE, en términos de SSP, en mujeres postmenopáusicas con cáncer de mama localmente recurrente o metastásico HR+, HER2-, que no hayan recibido ninguna terapia sistémica para
    esta enfermedad.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare the combination treatment of LY2835219 and NSAI therapy versus placebo plus NSAI therapy with respect to the following:
    ? OS
    ? OS rate at 1, 2, and 3 years;
    ? ORR (CR + PR);
    ? Duration of response (CR + PR);
    ? DCR (CR + PR + SD);
    ? CBR (CR + PR + SD ?6 months);
    ? Safety and tolerability;
    ? Change in symptom burden from baseline using the EORTC QLQ-C30, EORTC QLQ-BR23 (breast) questionnaire, and health status scores from the EQ-5D 5L;
    ? PK of LY2835219, its metabolites, and NSAI therapy
    Los objetivos secundarios del estudio son comparar el tratamiento politerápico con LY2835219 y un IANE con la
    administración de placebo y un IANE, en relación con los siguientes parámetros:
    ? Supervivencia global [SG];
    ? Tasa de SG al cabo de 1, 2 y 3 años;
    ? TRO (respuesta completa [RC] + RP);
    ? Duración de la respuesta [DdR] (RC + RP);
    ? TCE (RC + RP + EE);
    ? TBC (RC + RP + EE ? 6 meses);
    ? Seguridad y tolerabilidad.
    ? Variación en la carga sintomática, de acuerdo con el Cuestionario de Calidad de Vida Core 30 de la
    Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30) y el Cuestionario
    EORTC QLQ-BR23 (mama), así como con las puntuaciones del estado de salud del cuestionario EuroQol 5-
    Dimensiones 5 Niveles (EQ-5D 5L).
    ? Farmacocinética (FC) de LY2835219, sus metabolitos y del tratamiento con el IANE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? have a diagnosis of HR+, HER2- breast cancer;
    ? have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease;
    ? have postmenopausal status due to either surgical/natural menopause or amenorrheic (non-treatment-induced) for at least 12 months;
    ? have either measurable disease or nonmeasurable bone-only disease;
    ? have a performance status ?1 on the Eastern Cooperative Oncology Group (ECOG) scale;
    ? have adequate organ function;
    ? have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy;
    ? are female and ?18 years of age;
    ? are able to swallow capsules;
    1) presentar diagnóstico de cáncer de mama HR+, HER2-; 2) presentar enfermedad localmente recurrente que no sea resecable o no pueda tratarse con radioterapia (con fines curativos), o enfermedad metastásica;
    3) haber entrado en la menopausia (menopausia quirúrgica o natural) o no presentar menstruaciones (y que ello no haya sido inducido por el tratamiento) desde hace al menos 12 meses;
    4) presentar bien enfermedad mensurable o únicamente enfermedad ósea no mensurable;
    5) presentar una categoría funcional ? 1 en la escala del Eastern Cooperative Oncology Group
    (ECOG);
    6) presentar una función orgánica adecuada;
    7) haber interrumpido antes de la aleatorización cualquier
    radioterapia localizada previa administrada con fines paliativos o para tratar lesiones líticas con riesgo de fractura, y haberse recuperado de los efectos agudos del tratamiento;
    8) ser mujer y tener ? 18 años de edad;
    9) ser capaz de ingerir cápsulas;
    10) haber proporcionado el consentimiento informado antes de realizar cualquiera de los estudios específicos del estudio;
    11) ser responsable y estar disponible durante el estudio, y estar dispuesto a realizar los procedimientos del estudio.
    E.4Principal exclusion criteria
    ? have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. 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.
    ? have inflammatory breast cancer.
    ? have clinical evidence or a history of CNS metastasis. Screening is not required for enrollment.
    ? are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer. [Note: A patient may be enrolled if she received prior (neo)adjuvant endocrine therapy (including , but not limited to anti-estrogens or aromatase inhibitors) for localized disease. In addition, a patient may be enrolled if she has received ?2 weeks of NSAI in this disease setting immediately preceding screening and agrees to discontinue NSAI until study treatment initiation.]
    ? have received prior (neo)adjuvant endocrine therapy (e.g., anti-estrogens or aromatase inhibitors) with a disease-free interval ?12 months from completion of treatment.
    ? are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. [Note: Patients may be enrolled if they received prior (neo)adjuvant chemotherapy for localized disease.]
    ? have received prior treatment with everolimus
    ? have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
    ? have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to randomization
    ? are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Lilly clinical research physician (CRP) is required to establish eligibility.
    ? have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively.
    ? have had major surgery within 14 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).
    ? have received recent (within 28 days prior to randomization) yellow fever vaccination.
    ? 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, or preexisting Crohn?s disease or ulcerative colitis).
    ? have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
    12) presentar crisis visceral, diseminación linfangítica o carcinomatosis meníngea;
    13) presentar cáncer de mama inflamatorio;
    14) presentar indicios clínicos o antecedentes de metástasis en el sistema nervioso central (SNC);
    15) estar recibiendo en la actualidad o haber recibido anteriormente terapia endocrina para tratar el cáncer de mama localmente recurrente o metastásico;
    16) haber recibido terapia endocrina (neo)adyuvante y que el período sin enfermedad desde la finalización del tratamiento sea ? 12 meses;
    17) estar recibiendo en la actualidad o haber recibido previamente tratamiento quimioterápico para el cáncer de mama localmente recurrente o metastásico;
    18) haber recibido tratamiento previo con everolimus;
    19) haber recibido tratamiento previo con cualquier inhibidor de las CDK4/6 (o haber participado en cualquier ensayo clínico en el que se evalúe un inhibidor de las CDK4/6 y cuyo tratamiento aún esté enmascarado); 20) haber comenzado a recibir bifosfonatos o un fármaco aprobado dirigido al ligando RANK (RANK-L) < 7 días antes de la aleatorización; 21) estar recibiendo en la actualidad un fármaco en fase de investigación en un ensayo clínico, o estar participando 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;
    22) haber recibido tratamiento, en los 14 o 21 días previos a la aleatorización, con un fármaco sin actividad
    mielodepresora o con efecto mielodepresor, espectivamente, que no haya recibido aprobación por parte de las autoridades reguladoras para ninguna indicación; 23) haberse sometido a una intervención de cirugía mayor en el transcurso de los 14 días previos a la aleatorización; 24) haber recibido recientemente (en el transcurso de los 28 días previos a la aleatorización) vacunación contra la fiebre amarilla;
    25) presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir su participación en este estudio;
    26) presentar antecedentes personales de cualquiera de las siguientes enfermedades: síncope de etiología cardiovascular, taquicardia ventricular, fibrilación ventricular o paro cardiaco súbito;
    27) presentar antecedentes de cualquier otro
    cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ de cuello uterino), a menos que haya
    permanecido en remisión completa al menos durante 3 años, sin ningún tipo de tratamiento;
    28) haber recibido un alotrasplante o autotrasplante de hemocitoblastos; 29) presentar infecciones bacterianas o fúngicas activas o infecciones víricas detectables.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Supervivencia lire de progresion
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to Measured Progressive Disease or Death from Any Cause (Approximately 34 Months)
    Desde el inicio hasta progresion de la enfermedad o muerte por cualquier causa (Aproximadamente 34 meses)
    E.5.2Secondary end point(s)
    ? Overall Survival (OS)
    ? Objective Response Rate (ORR)
    ? Duration of Response (DoR)
    ? Disease Control Rate (DCR):
    ? Clinical Benefit Rate (CBR)
    ? Safety and tolerability endpoints (e.g. physical examination, adverse event collection, lab tests, dosing information)
    ? Change in symptom burden using EORTC QLQ-C30, EORTC QLQ-BR23 questionnaire
    ? Change in health status using the EQ-5D 5L
    ? Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2835219, its Metabolites, and NSAI Therapy:
    - Supervivencia global (SG)
    - Tasa de respuestas objetivas (TRO)
    - Duración de la respuesta (DdR)
    - Tasa de control de la enfermedad (TCE)
    - Tasa de beneficio clínico (TBC)
    - Variación en la carga sintomática, de acuerdo con el Cuestionario de Calidad de Vida Core 30 de la
    Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30) y el Cuestionario
    EORTC QLQ-BR23 (mama),
    - Variacion en las puntuaciones del estado de salud del cuestionario EuroQol 5- Dimensiones 5 Niveles (EQ-5D 5L).
    - Farmacocinética (FC) de LY2835219, sus metabolitos y del tratamiento con el IANE
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: Baseline to approximately 82 Months

    ORR, DoR, CBR, safety and tolerability endpoints (e.g. physical examination, adverse event collection, lab tests, dosing information change in symptom burden using the EORTC QLQ-C30, EORTC QLQ-BR23, change in health status using the EQ-5D 5L: Baseline to approximately 34 mont

    PK: Baseline up to approximately 4 months
    SP: DEsde El inicio hasta aproximadamente 82 meses
    Tasa de respuestas objetivas (TRO)
    - Duración de la respuesta (DdR)
    - Tasa de control de la enfermedad (TCE)
    - Tasa de beneficio clínico (TBC)
    - Variación en la carga sintomática, de acuerdo con el Cuestionario de Calidad de Vida Core 30 de la
    Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30) y el Cuestionario
    EORTC QLQ-BR23 (mama),
    - Variacion en las puntuaciones del estado de salud del cuestionario EuroQol 5- Dimensiones 5 Niveles (EQ-5D 5L).
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    All patients will receive NSAI (anastrozole or letrozole)
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Russian Federation
    Slovakia
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    ultimo paciente ultima visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 143
    F.4.2.2In the whole clinical trial 450
    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 ending study treatment in trial will enter long term follow up until death or study ends. For those patients on treatment at time of study completion, may continue to receive treatment in another period of the study until discontinuation criteria has been met. Placebo will no longer be given. The patient will continue to be under the care of her physician for continued medical treatment and support after participation in the trial
    Las pacientes terminen el tratamiento del estudio y continúen experimentando beneficio clínico podrán continuar recibiendo el tratamiento del estudio en el período de acceso continuado, hasta que se constate uno de los criterios de interrupción. Durante el período de acceso continuado no se continuará administrando placebo . Lilly informará a los investigadores del inicio del período de acceso continuado.
    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 Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 00:03:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA