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    Summary
    EudraCT Number:2008-006728-73
    Sponsor's Protocol Code Number:GENOM-008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-02-19
    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 number2008-006728-73
    A.3Full title of the trial
    Ensayo Clínico abierto, fase II, de tratamiento neo-adyuvante de Sunitinib (SU11248) previo al tratamiento con irradiación y concomitante a la misma, en pacientes con Glioblastoma RPA-V-VI y sólo biopsia
    A.4.1Sponsor's protocol code numberGENOM-008
    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 SponsorGRUPO ESPAÑOL DE NEUROONCOLOGIA MEDICA
    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 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 Information not present in EudraCT
    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 nameSUNITINIB
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsunitinib
    D.3.9.3Other descriptive nameSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    Glioblastoma clase RPA V-VI, no resecable
    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
    · Analizar la actividad clínica en términos de respuesta objetiva tras 8 semanas de tratamiento con sunitinib
    · Tolerancia del tratamiento combinado radio-sunitinib
    E.2.2Secondary objectives of the trial
    · Supervivencia al año
    · Determinar el número de pacientes libres de deterioro neurológico antes de la irradiación.
    · Determinar el número de pacientes que finalizan el tratamiento (neo-adyuvancia y tto combinado)
    · Supervivencia libre de progresión
    · Supervivencia total
    · Estudio sérico de marcadores biológicos de respuesta
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio sérico de marcadores biológicos de respuesta, fecha 18-09-2008, versión nº1.
    Objetivos:
    -Evaluar los niveles circulantes de factores angiogénicos en pacientes con glioblastoma tratados con sunitinib mediante la técnica de ELISA. Su fin es intentar correlacionar los resultados obtenidos de expresión de marcadores circulantes como VEGF-A (“vascular endothelial growth factor”) o PDGF-BB (“platelet-derived growth factor-BB”) con el efecto obtenido sobre el tumor al tratar con sunitinib.
    E.3Principal inclusion criteria
    1. Pacientes con Glioblastoma, no resecables, con sólo biopsia estereotáxica como tratamiento quirúrgico.
    2. Enfermedad medible y con captación de contraste &#8805; 2cm
    3. Dosis estables de DXM durante la semana previa a la inclusión.
    4. Performance Status 0-1-2
    5. Edad &#8804;75 años
    6. MMS > 25/30 (apéndice)
    7. Índice de Barthel > 50% (apéndice)
    8. La incisión quirúrgica debe haber cicatrizado antes de la aleatorización.
    9. RMN basal realizada máximo 3 semanas antes de iniciar el tratamiento que reúna las condiciones especificadas en el protocolo (se acepta la RMN realizada para la neuronavegación y la biopsia como basal si reúne las condiciones del protocolo)
    10. FEVI > 50% (Muga)
    11. Adecuada reserva medular (neutrófilos ³ 2000x109/L, plaquetas ³ 100x109/L, hemoglobina ³ 10 g/dl.
    12. No haber recibido tratamiento previo con quimioterapia o irradiación
    13. Creatinina < 1,5 veces el límite superior de normalidad del laboratorio que realice el análisis.
    14. Bilirrubinas sérica< 1,5/ULN, SGOT y SGPT £ 2,5 veces el límite superior de normalidad del laboratorio que realice el análisis. Fosfatasas alcalinas séricas < 3/ULN
    15. Método anticonceptivo eficaz en los pacientes y sus parejas
    16. Consentimiento Informado
    E.4Principal exclusion criteria
    1. Radioterapia o quimioterapia previas para el tratamiento del glioma.
    2. Menos de 5 años de cualquier neoplasia infiltrante previa.
    3. Hemorragia cerebral grave tras la biopsia
    4. Tratamiento anticomicial inductor/inhibidor del enzima CYP3A4: fenitoina, carbamacepina, fenobarbital u otros fármacos que interaccionen con el metabolismo de sunitinib, y que no pueda ser substituido por otro fármaco sin interacciones con sunitinib. (apéndice)
    5. Embarazo o lactancia
    6. Enfermedad cardiovascular (activa) o no controlada tales como hipertensión, angor instable, fallo cardíaco congestivo grado II (NYHA), arritmia cardíaca, infarto de miocardio previo, hasta 1 año antes de la aleatorización.
    7. Tratamiento instaurado actualmente con dosis terapéuticas de anticoagulantes derivados de coumarina (courmarina, warfarina) o en una semana previa al inicio del sunitinib. Se permite la administración de heparinas de bajo peso molecular para control de TVP.
    8. Paciente con TEP
    9. HTA con valores superiores a 150/100 no controlables con los fármacos antihipertensivos estándar.
    10. Cicatriz no curada, úlceras o fractura ósea
    11. Diátesis hemorrágica o coagulopatía.
    E.5 End points
    E.5.1Primary end point(s)
    - Variable Principal: evaluación de la respuesta al tratamiento con sunitinib a las 8 semanas, basada en los criterios de MacDonald (específicos para este Ensayo Clínico) y RMN, y su toxicidad según los criterios NCI-CTC versión 3.0.

    - Variables secundarias:
    Porcentaje de pacientes libres de deterioro neurológico antes de la irradiación
    Porcentaje de pacientes que finalizan el tratamiento
    Supervivencia global
    Supervivencia libre de progresión
    Supervivencia al año
    Estudio sérico de marcadores biológicos de respuesta
    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 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
    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 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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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 Decision2009-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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