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    Summary
    EudraCT Number:2010-020395-28
    Sponsor's Protocol Code Number:ARD11588(MM-121-02-02-03)
    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:2011-02-18
    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 number2010-020395-28
    A.3Full title of the trial
    Estudio de fase II, aleatorizado, doble ciego de exemestano +/- MM-121 en mujeres posmenopáusicas con cáncer de mama Her2 negativo localmente avanzado o metastásico, con receptores de estrógeno positivo (ER+) y/o receptores de progesterona positivos (RP+)_______A Randomized, Double-Blind Phase 2 trial of Exemestane +/- MM-121 in Postmenopausal Women with Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+), Her2 negative Breast Cancer
    A.4.1Sponsor's protocol code numberARD11588(MM-121-02-02-03)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERRIMACK PHARMACEUTICALS
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code MM-121 (SAR256212)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMM-121 (SAR256212)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cáncer de mama_____Breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si la combinación de MM-121 + exemestano es más eficaz que la monoterapia con exemestano basándose en la supervivencia sin progresión (SSP)
    E.2.2Secondary objectives of the trial
    Comparar la eficacia de la combinación de MM-121 + exemestano con exemestano en monoterapia utilizando
    - Supervivencia total
    - Tasa de respuesta objetiva y duración de la respuesta
    - Tasa de beneficio clínico
    Determinar el perfil de seguridad de la combinación de MM-121 + exemestano
    Determinar los parámetros de inmunogenia de la combinación de MM-121 + exemestano
    Determinar los parámetros farmacocinéticos de la combinación de MM-121 + exemestano en un subconjunto de pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para su inclusión, las pacientes deben ser/tener/estar:

    1. Progresión de la enfermedad localmente avanzada o metastásica después del tratamiento antiestrogénico previo, o progresión durante el tratamiento adyuvante (o en los 6 meses siguientes a la finalización del mismo) con un IA no esteroideo y/o tamoxifeno.
    2. Cáncer de mama RE+ y/o RP+ y Her2 negativo, confirmado histológica o citológicamente
    3. Enfermedad localmente avanzada o metastásica documentada con al menos una lesión medible radiológicamente, definida según los criterios RECIST v1.1. Excepción: las pacientes que tienen únicamente enfermedad ósea son idóneas si tienen al menos 2 lesiones en una gammagrafía ósea o en otra modalidad radiológica (p. ej., radiografía, TAC, PET-TAC o RM) y tienen progresión documentada de la enfermedad con tratamiento previo determinada por la aparición de nuevas lesiones.
    4. Capaz de comprender y firmar un consentimiento informado (o tener un representante legal que puede hacerlo)
    5. Mujeres posmenopáusicas, definidas por lo siguiente:
    - más de 5 años desde el inicio de la menopausia
    - Concentraciones de hormona luteinizante/hormona folículo estimulante en el intervalo posmenopáusico en las mujeres cuya menopausia se produjo menos de 5 años antes de la inclusión
    6. Tejido tumoral sin teñir disponible para su análisis
    7. Escala funcional (EF) ECOG inf ó igual a 2
    8. Reservas adecuadas de la médula ósea, que se manifiestan por:
    - RAN sup a 1500/µl sin uso de factores de crecimiento hematopoyéticos, y
    - Recuento plaquetario sup a 100.000/µl, y
    - Hemoglobina sup a 9 g/dl
    9. Función hepática adecuada, que se manifiesta por:
    - Bilirrubina sérica total inf ó igual 1,5 x LSN
    - Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina inf o igual a 2,5 x LSN (inf o igual a 5 x LSN es aceptable si hay metástasis hepáticas y inf o igual a 5 x LSN de fosfatasa alcalina es aceptable si hay metástasis óseas)
    10. Función renal adecuada, que se manifiesta por una creatinina sérica inf ó igual 1,5 x LSN
    11. Recuperada de los efectos clínicamente significativos de cualquier intervención quirúrgica, radioterapia o tratamiento antineoplásico previo. Las pacientes con neuropatía periférica conocida deben tener afectación de grado 1 o menor, según los criterios terminológicos comunes del National Cancer Institute [NCI CTCAE], versión 4.0, para poder ser incluidas.
    12. Sup ó igual a 18 años de edad
    E.4Principal exclusion criteria
    1. Haber recibido tratamiento previo con exemestano
    2. Haber recibido más de un régimen quimioterápico previo por enfermedad metastásica
    3. Enfermedad visceral extensa (metástasis rápidamente progresivas y potencialmente mortales, incluidas las metástasis linfangíticas sintomáticas)
    4. Enfermedad sintomática del SNC
    5. Antecedente de otra neoplasia maligna en los últimos 5 años. Serán elegibles las pacientes con antecedentes de cáncer in situ o cáncer cutáneo de células basales o escamosas. Las pacientes con otras neoplasias malignas serán elegibles si fueron curadas sólo con intervención quirúrgica y han estado libres de enfermedad de forma continua durante al menos 5 años.
    6. Infección activa, o fiebre superior a 38,5 °C inexplicable durante las visitas de selección o en la primera visita programada de administración del fármaco, que en opinión del investigador podría poner en peligro la participación de la paciente en el estudio o afectar al resultado del estudio. Queda a discreción del investigador incluir a las pacientes con fiebre tumoral.
    7. Hipersensibilidad conocida a cualquiera de los componentes de MM-121 o haber presentado reacciones de hipersensibilidad a anticuerpos monoclonales totalmente humanos
    8. Haber recibido otro tratamiento antitumoral reciente, como:
    a. Tratamiento en investigación administrado en los 30 días previos a la primera visita programada de administración del fármaco en este estudio
    b. Radioterapia u otro tratamiento hormonal estándar en los 14 días previos a la primera visita programada de administración del fármaco en este estudio, que incluye además, si es necesario, el marco temporal para cualquier efecto tóxico real o previsto por dicha radioterapia o tratamiento
    9. Insuficiencia cardíaca congestiva de clase III o IV de la NYHA o FEVI inferior a 55%. También se excluyen las pacientes con un antecedente significativo de cardiopatía (es decir, tensión arterial incontrolada, angina inestable, infarto de miocardio en el año anterior, o arritmias ventriculares que precisan medicación)
    10. Accidente cerebrovascular (ACV) reciente (en el año anterior)
    11. Antecedentes de reacciones alérgicas atribuidas a compuestos con composición química o biológica similar al exemestano
    12. Tratamiento previsto con bisfosfonatos que no se ha iniciado antes de la aleatorización. Se permite el tratamiento de las metástasis óseas con bisfosfonatos, aunque se debe haber iniciado antes de la primera dosis del tratamiento asignado aleatoriamente.
    13. Cualquier otra afección médica que el investigador considere que pueda interferir con la capacidad de la paciente para firmar el consentimiento informado y para colaborar y participar en el estudio, o que pueda interferir con la interpretación de los resultado
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia sin progresión (SSP)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity parameters of the MM-121 + exemestane combination
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 130
    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 Decision2011-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    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
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