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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2010-019051-21
    Sponsor's Protocol Code Number:ML25152
    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:2010-03-23
    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 number2010-019051-21
    A.3Full title of the trial
    Estudio de un único brazo, fase II de bevacizumab en combinación con temozolomida en pacientes con glioblastoma multiforme recurrente
    A.4.1Sponsor's protocol code numberML25152
    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 SponsorRoche Farma, 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 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 Yes
    D.2.1.1.1Trade name AVASTIN 25 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 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.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.2Current sponsor codeRo4876646
    D.3.9.3Other descriptive nameBEVACIZUMAB
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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 Yes
    D.2.1.1.1Trade name AVASTIN 25 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 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.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.2Current sponsor codeRo4876646
    D.3.9.3Other descriptive nameBEVACIZUMAB
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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
    Pacientes con glioblastoma multiforme recurrente.
    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
    Supervivencia libre de progresión a los 6 meses (24 semanas) en este grupo de pacientes, según los criterios MacDonald adaptados.
    E.2.2Secondary objectives of the trial
    Valoración de la tasa de respuesta.
    Evaluación de la supervivencia global y la mediana de la supervivencia libre de progresión
    Valoración de la seguridad y tolerabilidad de bevacizumab en combinación con temozolomida como tratamiento en pacientes con gliblastoma multiforme recurrente.
    Relación entre la tasa de respuestas objetivas y el estado de metilación del promotor de MGMT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Firma del consentimiento informado
    2. Edad >=18 años
    3. Diagnostico histológico de glioblastoma multiforme (GBM) confirmado mediante resección quirúrugica o biopsia.
    4. Deben ser pacientes en primera recaída tratada con quimio-radioterapia y posteriormente quimioterapia con temozolomida 150-200 mg/m2 días 1-5 cada 28 días Durante al menos tres ciclos. Debe haber pasado al menos 4 semanas desde el tratamiento previo con temozolamida y 3 meses desde la última dosis de radioterapia .
    5. Estado funcional de la OMS<=2
    6. Metodo efectivo de contracepción en los pacientes y sus parejas.
    7. Dosis estable o decreciente de corticoides durante los cinco días anteriores a la inclusión en el estudio
    8. Función hematológica adecuada:
    Recuento absoluto de neutrófilos (RAN) >=1,5 x 109/l
    Recuento de plaquetas >= 100 x 109/l
    Hemoglobina >= 10 g/dl (pueden realizarse transfusiones para mantener o superar esta cifra) 9.Función hepática adecuada
    Bilirrubina total <= 1,5 x LSN
    AST y ALT <= 2,5 x LSN
    10. Función renal adecuada
    Creatinina <= 1,25 x LSN
    Tira reactiva en orina para proteinuria < 2+. Los pacientes en que se descubra una proteinuria>= 2+ en un análisis de orina con tira reactiva en el período basal deberán someterse a una recogida de orina durante 24 horas y presentar <= 1,0 g de proteínas en 24 horas
    O BIEN
    Cociente entre proteínas y creatinina en orina (PCO) <= 1,0
    11. Cociente internacional normalizado (INR) o TP (s) y tiempo de tromboplastina parcial activado (TTPa):
    <1,5 x LSN (salvo en los sujetos tratados con anticoagulantes) en ausencia de intención terapéutica de anticoagular al sujeto.
    dentro de los límites terapéuticos (según la referencia médica en el centro) en presencia de intención terapéutica de anticoagular al sujeto
    NOTA: se permitirá el uso de anticoagulantes en dosis plenas siempre que el INR o TTPa se encuentre dentro de los límites terapéuticos (según la referencia médica en el centro) y el paciente haya recibido una dosis estable de anticoagulantes durante al menos dos semanas antes de la inclusión en el estudio. Según las directrices de la ASCO, las HBPM han de ser la opción de elección
    12. Disposición y capacidad de cumplir el protocolo según lo considerado por el investigador
    E.4Principal exclusion criteria
    1. Signos de hemorragia reciente en la RM del cerebro. No obstante, se permitirá participar en el estudio a los pacientes con presencia clínicamente asintomática de hemosiderina, cambios hemorrágicos en resolución relacionados con la cirugía y presencia de hemorragia punteada en el tumor.
    2. Haber sido tratado previamente con bevacizumab 3. Hipertensión arterial controlada de manera inadecuada (definida como una presión arterial sistólica > 150 mm Hg o una presión arterial diastólica > 100 m Hg)
    4. Antecedentes de crisis hipertensivas o encefalopatía hipertensiva
    5. Insuficiencia cardíaca congestiva de grado II o superior de la New York Heart Association (NYHA)
    6. Antecedentes de infarto de miocardio o angina de pecho inestable durante los seis meses anteriores a la inclusión en el estudio
    7. Antecedentes de ictus o AIT durante los seis meses anteriores a la inclusión en el estudio
    8. Vasculopatía importante (p. ej., aneurisma aórtico con necesidad de reparación quirúrgica o trombosis arterial periférica reciente) durante los seis meses anteriores a la inclusión en el estudio
    9. Antecedentes de hemoptisis>=grado 2 según los criterios CTC del NCI durante el mes anterior a la inclusión en el estudio
    10. Datos de diátesis hemorrágica o coagulopatía (en ausencia de anticoagulación terapéutica)
    11. Intervención de cirugía mayor, biopsia abierta, biopsia intracraneal, derivación ventriculoperitoneal o lesión traumática importante durante los 28 días anteriores a la inclusión en el estudio
    12. Biopsia con aguja gruesa (excluida una biopsia intracraneal) u otra intervención de cirugía menor durante los siete días anteriores a la inclusión. Colocación de un dispositivo de acceso vascular central (DAVC), en caso de realizarse durante los dos días anteriores a la administración de bevacizumab
    13. Antecedentes de fístula abdominal o perforación digestiva durante los seis meses anteriores a la inclusión en el estudio
    14. Antecedentes de absceso intracraneal durante los seis meses anteriores a la inclusión en el estudio
    15. Herida importante no cicatrizada, úlcera activa o fractura ósea no tratada
    16. Mujeres embarazadas o que alimenten al pecho a sus hijos
    NOTA: tendrá que evaluarse una prueba de embarazo en suero durante los siete días anteriores al inicio del tratamiento del estudio
    17. Cualquier neoplasia maligna previa tratada con intención curativa durante los cinco años anteriores a la inclusión, salvo un carcinoma basocelular de la piel limitado, un carcinoma espinocelular de la piel o un carcinoma in situ del cuello uterino controlado de manera adecuada
    18. Datos de cualquier infección activa con necesidad de hospitalización o antibióticos IV durante las dos semanas anteriores a la inclusión en el estudio
    19. Pacientes que presentan cualquier otra enfermedad, ya sea metabólica o psicológica, o tienen signos en la exploración clínica o las investigaciones especiales (incluidos datos analíticos) que generan una sospecha razonable de una enfermedad o proceso que contraindica el uso del fármaco en investigación o que podría afectar al cumplimiento del paciente de los requisitos del estudio o supondría un mayor riesgo para él de sufrir posibles complicaciones del tratamiento
    20. Tratamiento actual o reciente (durante los 30 días anteriores al reclutameinto) con otro fármaco en investigación o participación en otro estudio de investigación
    21. Hipersensibilidad conocida a alguno de los excipientes de la formulación de bevacizumab o al régimen de quimioterapia (temozolomida)
    22. Cualquier contraindicación a temozolomida recogida en la ficha técnica local
    23. Hipersensibilidad a productos derivados de células de ovario de hámster chino o a otros anticuerpos humanizados o humanos recombinantes
    24. Incapacidad de cumplir la administración del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión a los 6 meses (24 semanas)
    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 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    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 Information not present in EudraCT
    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
    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 state33
    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 Decision2010-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-31
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