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    Summary
    EudraCT Number:2014-000838-39
    Sponsor's Protocol Code Number:GEINO14-01
    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:2014-05-08
    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 number2014-000838-39
    A.3Full title of the trial
    Clinical Trial Phase IIB randomized, multicenter, of continuation or non-continuation with 6 cycles of temozolomide after the first 6 cycles of standard first-line treatment in patients with glioblastoma.
    Ensayo Clínico fase IIB, aleatorizado, multicéntrico, de continuación o no continuación con 6 ciclos de temozolomida tras los 6 primeros ciclos de tratamiento estándar en primera línea en pacientes con glioblastoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial in patients with glioblastoma
    Ensayo clínico en pacientes con glioblastoma
    A.4.1Sponsor's protocol code numberGEINO14-01
    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 SponsorGEINO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMarketing Farmacéutico Investigación Clínica
    B.5.2Functional name of contact pointMFAR S.L.
    B.5.3 Address:
    B.5.3.1Street AddressC/ Secretario Coloma 64
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934344412
    B.5.5Fax number0034932531168
    B.5.6E-mailsecretaria@geino.es
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Capsule, hard
    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 INNTEMOZOLOMIDA
    D.3.9.2Current sponsor codePR1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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
    Patients diagnosed of Glioblastoma
    Pacientes diagnosticados de Glioblastoma
    E.1.1.1Medical condition in easily understood language
    pacientes con tumor cerebral
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Detect differences in the probability of progression-free survival at 6 months between patients with methylated or unmethylated MGMT and residual disease or not, to receive an additional 6 cycles of temozolomide.
    Detectar diferencias en la probabilidad en supervivencia libre de progresión a los 6 meses entre los pacientes con MGMT metilados o no metilados y por enfermedad residual o no, a recibir 6 ciclos adicionales de temozolomida.
    E.2.2Secondary objectives of the trial
    Perfil de Seguridad/toxicidad
    Actividad Tumoral
    Supervivencia Global
    Cambios en el uso de corticoides
    Cambios en el estado neurológico
    Metilación de MGMT
    Safety Profile / toxicity
    Tumoral activity
    Global survival
    Changes in the use of corticosteroids
    Changes in neurological status
    MGMT methylation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Immunohistochemical study of different markers / enzymes temodal resistance
    Estudio inmunohistoquímico de diferentes marcadores/enzimas de resistencia a temodal
    E.3Principal inclusion criteria
    1. Ability to understand and sign the informed consent document .
    2 . Age greater than or equal 18.
    3 . Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease.
    4. Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made ​​in the center of origin the result of the center will be accepted ) .
    5 . Stable dose of dexamethasone in the inclusion never above corticides dose received in cycle 6 of the adjuvant .
    6. Index greater than or equal 60 % Karnofsky
    7. All patients must show no progression of disease in a brain MRI as defined in RANO established criteria before randomization .
    8. Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle. ( MRI performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed)
    9. Adequate bone marrow reserve : hematocrit ? 29% , WBC> 3,000 / mcL , RAN ? 1,500 cells / ul , platelets ? 100,000 cells / ul.
    10. Creatinine <1.5 times the upper limit of normal of the laboratory performing the analysis.
    11. Serum bilirubin <1.5 / ULN SGOT , SGPT < 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases .
    12. Effective contraceptive method in patients and their partners.
    1. Capacidad para entender y firmar el documento de consentimiento informado.
    2. Edad mayor o igual 18 años.
    3. Pacientes con glioblastoma según clasificación WHO (glioblastoma) que hayan recibido quimio-radioterapia y quimioterapia basada en temozolomida (esquema de Stupp) y hayan completado 6 ciclos de temozolomida adyuvante (con o sin bevacizumab) en el contexto del tratamiento estándar sin haber presentado progresión de enfermedad.
    4. Disponibilidad de tejido tumoral de la primera cirugía para realizar la revisión histológica centralizada, para la determinación del estudio de MGMT si no ha realizado en el centro de origen. (En caso de que se hubiera realizado en el centro de origen se aceptará el resultado del centro).
    5. Dosis estables de Dexametasona en la inclusión nunca superiores a la dosis de corticides recibidas en el ciclo 6 de la adyuvancia.
    6. Índice de karnofsky mayor o igual 60%
    7. Todos los pacientes deben mostrar ausencia de progresión de enfermedad en una resonancia magnética del cerebro según la definición establecida en los Criterios RANO antes de la aleatorización.
    8. RMN basal del estudio realizada un máximo de 6 semanas previas a la inclusión, en la que no se observe progresión y haya permitido administrar el 6º ciclo asistencial. (La RMN realizada tras el 6 ciclo de la adyuvancia,también es aceptable siempre y cuando no se observe progresión)
    9. Adecuada reserva medular: hematocrito ? 29%, leucocitos > 3000 / mcl, RAN ? 1.500 células / ul, plaquetas ? 100.000 células / ul.
    10. Creatinina < 1,5 veces el límite superior de normalidad del laboratorio que realice el análisis.
    11. Bilirrubina sérica < 1,5/ULN SGOT, SGPT < 2,5 veces el límite superior de normalidad del laboratorio que realice el análisis. Fosfatasas alcalinas séricas < 3/ULN.
    12. Método anticonceptivo eficaz en los pacientes y sus parejas.
    E.4Principal exclusion criteria
    1. Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
    2. Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
    3. Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth.
    4. Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
    5. Concurrent disease that prevents the continuation of treatment temozolomia .
    6. Any treatment or surgery after initial diagnosis irradiation since starting treatment with radiotherapy and adjuvant temozolomide and ..
    7. Intratumoral BCNU therapy in surgery for tumor recurrence ( second surgery ) . NOTE : Patients treated with intratumoral BCNU (or what is the same carmustine intratumoral or Gliadel ® ) in the first intervention can participate in the study.
    8. Presence of leptomeningeal dissemination.
    9. Pregnant or breastfeeding.
    10. Positive patients receiving combination antiretroviral therapy in HIV
    1. Menos de 5 años de cualquier neoplasia infiltrante previa. Se aceptan carcinoma in situ de cervix o carcinoma basocelular cutáneo.
    2. Tratamiento concomitante con otros agentes de investigación (excepto bevacizumab concomitante).
    3. Presencia de cualquier anomalía gastrointestinal clínicamente significativa, que pueda afectar la toma, el tránsito o la absorción del fármaco en estudio, tales como la incapacidad de tomar medicación en comprimidos por vía oral.
    4. Presencia de cualquier trastorno psiquiátrico o cognitivo que limite la comprensión o la firma del consentimiento informado y/o poner en peligro el cumplimiento de los requisitos de este protocolo.
    5. Enfermedad concurrente que impida la prosecución del tratamiento con temozolomia.
    6. Cualquier tratamiento con cirugía o irradiación posterior al del diagnóstico inicial desde que inició el tratamiento con radioterapia y temozolomida y adyuvancia..
    7. Tratamiento con BCNU intratumoral en la cirugía de la recidiva tumoral (segunda cirugía). NOTA: Los pacientes tratados con BCNU intratumoral (o lo que es lo mismo carmustina intratumoral o Gliadel®), en la primera intervención pueden participar en el estudio.
    8. Presencia de diseminación leptomeníngea.
    9. Mujeres embarazadas o en período de lactancia.
    10. Pacientes HIV positivo en tratamiento antirretroviral combinado.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is progression-free survival at 6 months or overall progression-free survival, according to the methylation status of the MGMT gene or the presence of residual disease at baseline MRI in patients with glioblastoma who have already received 6 cycles of adjuvant without progress and are randomized to continue with 6 cycles of TMZ or stop treatment.
    La variable primaria de eficacia es la supervivencia libre de progresión a los 6 meses o la supervivencia libre de progresión total, según el estado de metilación del gen MGMT o la presencia de enfermedad residual en la RMN basal, en pacientes con glioblastoma que han recibido ya 6 ciclos de adyuvancia sin progresar y que se aleatorizan a continuar con 6 ciclos de TMZ o detener el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression-free survival at 6 months after end of treatment
    Supervivencia libre de progresión a los 6 meses tras finalizar el tratamiento
    E.5.2Secondary end point(s)
    Safety Profile / toxicity
    Tumoral activity
    Global survival
    Changes in the use of corticosteroids
    Changes in neurological status
    MGMT methylation
    Perfil de Seguridad/toxicidad
    Actividad Tumora.
    Supervivencia Global
    Cambios en el uso de corticoides
    Cambios en el estado neurológico
    Metilación de MGMT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient exitus
    Hasta exitus del paciente
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 trial1
    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 concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    El ensayo se considerará cerrado desde el punto de vista normativo después de que los datos sobre las variables primarias y secundarias estén lo suficientemente preparadas como para su publicación.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    El seguimiento de los pacientes incluidos en el ensayo se realizará siguiendo la práctica clínica habitual
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-14
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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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