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    Summary
    EudraCT Number:2008-004457-15
    Sponsor's Protocol Code Number:EMD121974-012
    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:2010-05-25
    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 number2008-004457-15
    A.3Full title of the trial
    Cilengitide in subjects with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter - a multicenter, open-label Phase II study, investigating two cilengitide regimens in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) - CORE.

    Cilengitida en sujetos con glioblastoma multiforme
    recién diagnosticado que no presentan metilación en
    el promotor del gen MGMT: estudio en fase II,
    abierto y multicéntrico para investigar dos pautas de
    administración de cilengitida en combinación con el
    tratamiento de referencia (temozolomida con
    radioterapia concomitante, seguida de tratamiento de mantenimiento con temozolomida.
    A.3.2Name or abbreviated title of the trial where available
    CORE
    A.4.1Sponsor's protocol code numberEMD121974-012
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 Yes
    D.2.5.1Orphan drug designation numberEU3/03/184
    D.3 Description of the IMP
    D.3.1Product nameCilengitide
    D.3.2Product code EMD 121974
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNCilengitide
    D.3.9.1CAS number 188968-51-6
    D.3.9.2Current sponsor codeEMD 121974
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) 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.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 Yes
    D.2.5.1Orphan drug designation numberEU3/03/184
    D.3 Description of the IMP
    D.3.1Product nameCilengitide
    D.3.2Product code EMD 121974
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNCilengitide
    D.3.9.1CAS number 188968-51-6
    D.3.9.2Current sponsor codeEMD 121974
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed glioblastoma multiforme with unmethylated MGMT gene promoter status.
    Glioblastoma multiforme recién diagnosticado que no presentan metilación en el promotor del gen MGMT
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival time
    Período de
    supervivencia global (SG)
    E.2.2Secondary objectives of the trial
    * Evaluar el tiempo de SSP.
    * Evaluar la seguridad y la tolerabilidad de la
    combinación de cilengitida con tratamiento de
    referencia de RTX y TMZ en la población global del
    estudio.
    * Evaluar el perfil FC de cilengitida cuando se
    administra a diario (5 de 7 días) a razón de 2000 mg
    en combinación con RTX y TMZ en los días de RTX
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obtención del consentimiento informado escrito
    antes de realizar ninguna actividad relacionada con el estudio.
    2. GBM supratentorial recién diagnosticado y
    comprobado histológicamente (grado IV de la
    Organización Mundial de la Salud [OMS], incluidos
    los subtipos de GBM, como el gliosarcoma). El
    diagnóstico histológico deberá obtenerse a partir de
    una resección neuroquirúrgica del tumor o mediante
    una biopsia abierta (no se permite la biopsia
    estereotáctica).
    3. Disponibilidad de muestras de tejido tumoral de la
    cirugía o la biopsia abierta del GBM (bloque fijado
    en formol e incluido en parafina [FFIP]) para el
    análisis del estado del promotor del gen de MGMT y
    revisión anatomopatológica central.
    4. Estado no metilado del promotor del gen de la
    MGMT probado (es decir, cociente límite <2)
    mediante la prueba aplicada para determinar el estado del promotor del gen de la MGMT).
    5. Hombres y mujeres de >o=18 años de edad.
    6. Intervalo >o=2 semanas pero <o=7 semanas tras la cirugía o la biopsia antes de la primera administración del tratamiento del estudio.
    7. Disponibilidad de una RM-Gd postoperatoria
    realizada en <48 horas tras la cirugía (en caso de que no sea posible obtener una RM-Gd en <48 horas tras la cirugía, tiene que practicarse una RM-Gd antes de la aleatorización).
    8. Dosis de esteroides estable o decreciente durante
    días antes de la aleatorización.
    9. EF ECOG de 0-1.
    10. Cumple 1 de las siguientes clasificaciones del APR:*Clase III (edad <50 años y EF ECOG 0).
    * Clase IV (cumple uno de los criterios siguientes:
    a) Edad <50 años y EF ECOG 1 ó b) Edad >o=50
    años, sometido a resección tumoral parcial o total
    previa, Mini-Examen Cognoscitivo[MMSE] >o=27).
    * Clase V (cumple uno de los criterios siguientes: a)
    Edad >o=50 años y sometido a resección tumoral
    parcial o total previa, MMSE <27 o b) Edad >o=50
    años y sometido únicamente a biopsia tumoral
    previa).
    11. Valores de laboratorio (en las 2 semanas previas a la
    aleatorización):
    * Recuento absoluto de neutrófilos >o=1500/mm3.
    * Recuento de plaquetas >o=100,000/mm3.
    * Creatinina <o=1,5 x límite superior normal (LSN) o
    velocidad de aclaramiento de creatinina
    >o=60 ml/min.
    * Tiempo de protrombina (TP), cociente
    internacional normalizado (CIN) dentro de los
    límites normales y tiempo de tromboplastina
    parcial (TTP) por debajo del límite superior de
    normalidad.
    * Hemoglobina >o=10 g/dl.
    * Bilirrubina total <o=1,5 x LSN.
    * Aspartato aminotransferasa (AST) y alanina
    aminotransferasa (ALT) <o=2,5 x LSN (excepto
    cuando sea atribuible a antiepilépticos o elevación
    transitoria en el postoperatorio atribuible a
    narcóticos).
    * Fosfatasa alcalina <o=2,5 x LSN.
    E.4Principal exclusion criteria
    1. Quimioterapia en los 5 años previos.
    2. RTX previa en la cabeza (salvo la radioterapia en
    dosis bajas para tratar la tiña del cuero cabelludo).
    3. El paciente recibe fármacos en investigación
    concomitantes o ha recibido un fármaco en
    investigación en los 30 días previos a la primera
    dosis de cilengitida.
    4. Tratamiento antiangiogénico sistémico previo.
    5. Colocación de una oblea de Gliadel® en una
    intervención quirúrgica.
    6. Cirugía mayor prevista para otros procesos.
    7. Antecedentes de enfermedad ulcerosa péptica
    reciente (úlcera gástrica, duodenal o esofágica
    demostrada por endoscopia) en los 6 meses previos al
    reclutamiento.
    8. Antecedentes de un proceso maligno. Los sujetos con
    carcinoma cervical in situ o carcinoma basocelular de
    la piel tratados con intención curativa o los que no
    hayan tenido otros procesos malignos durante >o=5
    años son elegibles para este estudio.
    9. Antecedentes de trastornos de la coagulación
    asociados con episodios hemorrágicos o trombóticos
    recurrentes.
    10. Insuficiencia miocárdica clínicamente manifiesta
    (clase III o IV de la New York Heart Association
    [NYHA]) o antecedentes de infarto de miocardio
    durante los 6 meses previos; o hipertensión arterial
    incontrolada.
    11. Incapacidad para someterse a RM-Gd.
    12. Enfermedad concurrente, incluida infección aguda
    (p.ej., VIH), que pueda poner en peligro la capacidad
    del sujeto para someterse a los procedimientos
    detallados en este protocolo con una seguridad
    razonable.
    13. El sujeto es una mujer embarazada (prueba de
    gonadotropina coriónica humana beta [?-HCG] en
    suero positiva en la selección) o actualmente lactante,
    o puede quedarse embarazada y tiene intención de
    quedarse embarazada o dejar embarazada a su pareja
    durante el estudio o en los 6 meses siguientes a la
    participación en el estudio o no está de acuerdo en
    seguir métodos aceptables de control de la natalidad
    como anticonceptivos hormonales, dispositivo
    intrauterino, preservativos o la esterilización para
    evitar la concepción durante el estudio y durante al
    menos 6 meses después de recibir la última dosis del
    tratamiento del estudio.
    14. Alcoholismo o drogadicción actual.
    15. Hipersensibilidad conocida al tratamiento del
    estudio.16. Incapacidad legal o capacidad legal limitada.
    17. Presencia de cualquier circunstancia psicológica,
    familiar, sociológica o geográfica que pueda
    obstaculizar el cumplimiento del protocolo del
    estudio y del esquema de seguimiento.
    18. Signos y síntomas indicativos de una encefalopatía
    espongiforme transmisible o de que la sufran o hayan
    sufrido familiares.
    E.5 End points
    E.5.1Primary end point(s)
    Investigar el tiempo de supervivencia global en pacientes que reciben 2 regímenes diferentes de Cilengitida 200 mg en combinación con terapia estandar de RTX y TMZ .
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    * El último sujeto ha recibido la última dosis de medicación del estudio (incluido un
    seguimiento de 28 días).
    * Puede responderse a los objetivos del estudio, es decir, se ha realizado el análisis
    final de la supervivencia.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 260
    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 Decision2010-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
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