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    Summary
    EudraCT Number:2005-002097-30
    Sponsor's Protocol Code Number:A6181037
    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:2010-03-15
    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 number2005-002097-30
    A.3Full title of the trial
    PROTOCOLO DE ACCESO EXPANDIDO CON SU011248 PARA EL TRATAMIENTO SISTÉMICO DE PACIENTES CON CARCINOMA DE CÉLULAS RENALES METASTÁTICO, NO ELEGIBLES PARA PARTICIPAR EN OTROS PROTOCOLOS DE SU011248 Y QUE PUEDAN BENEFICIARSE DEL TRATAMIENTO CON SU011248

    A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248
    A.4.1Sponsor's protocol code numberA6181037
    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 SponsorPfizer, 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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSutent
    D.3.2Product code su011248
    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 INNMalato de Sunitinib
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    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.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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSutent
    D.3.2Product code su011248
    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 INNMalato de Sunitinib
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 3
    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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSutent
    D.3.2Product code su011248
    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 INNMalato de Sunitinib
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Carcinoma de células renales con metástasis confirmado histopatológicamente

    Histopathologically confirmed renal cell carcinoma with metastases
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10038415
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario de este protocolo es proporcionar acceso al tratamiento con SU011248 a pacientes con CCR metastásico, siempre y cuando se cumplan todas las condiciones siguientes:

    a) Pacientes que sean no elegibles para participar en estudios clínicos en marcha con SU011248 (si en la institución está abierta la inclusión a algún protocolo en Fase 1, 2 o 3 para pacientes con CCR), excepto aquellos pacientes que hayan recibido tratamiento con IFN-alfa. en el protocolo A6181034 y tuvieran documentación radiológica de progresión de la enfermedad o fueran intolerantes a IFN-alfa, y

    b) Pacientes que potencialmente puedan obtener un beneficio clínico derivado del tratamiento con SU011248, en opinión del investigador.
    E.2.2Secondary objectives of the trial
    . Perfil de seguridad y tolerabilidad de SU011248
    . Eficacia antitumoral de SU011248 como fármaco único administrado a dosis de 50 mg por vía oral en pacientes con CCR metastático.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para poder ser elegible para ser incluido en el estduio, los pacientes deben cumplir todos los criterios siguientes:
    1. Carcinoma de células renales con metástasis confirmado histopatológicamente.
    2. No elegible para participar en estudios clínicos en marcha con SU011248 (si en la institución existe algún protocolo de SU011248 de Fase 1, 2 o 3 para pacientes con CCR en fase de reclutamiento).
    3. En opinión del médico a cargo del paciente, debe existir potencial de obtener un beneficio clínico derivado del tratamiento con SU011248.
    4. Hombre o mujer de 18 años de edad o mayor.
    5. Si ha sido tratado previamente por CCR metastático, resolución de todos los efectos tóxicos agudos de la terapia sistémica previa, radioterapia o procedimiento quirúrgico hasta el grado ≤1 de los criterios NCI CTCAE Versión 3.0. (Apéndice 3)
    6. Función orgánica adecuada definida por los siguientes criterios:
    Bilirrubina sérica total ≤2 x LSN (excepto los pacientes con enfermedad de Gilbert)
    Transaminasas séricas <5 x LSN
    Creatinina sérica ≤2 x LSN
    Recuento absoluto de neutrófilos (RAN) ≥1000/mm3 sin soporte de factores de crecimiento
    Plaquetas ≥75,000/mm3
    Hemoglobina ≥8.0 g /dL
    7. Documento de consentimiento informado fechado y firmado indicando que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio antes de la inclusión.
    8. Deseo y capacidad de cumplir con las visitas programadas, plan de tratamiento, analíticas y otros procedimientos de estudio.
    9. De acuerdo a los requerimientos de las regulaciones locales, Ej. Reino Unido, estado funcional ECOG de 0, 1 o 2.
    E.4Principal exclusion criteria
    Los pacientes que presenten alguno de los siguientes criterios no podrán participar en el estudio:
    1. Tratamiento actual en otro ensayo clínico terapéutico
    2. Insuficiencia cardiaca congestiva, infarto de miocardio, injerto bypass de arteria coronaria, en los 6 meses anteriores, angina severa o inestable en curso o arritmia inestable que requiera medicación
    3. Tratamiento previo en un ensayo de SU011248, excepto para aquellos pacientes que hayan recibido tratamiento con IFN-alfa en el Protocolo A6181034 y tuvieran documentación radiológica de progresión de la enfermedad o fueran intolerantes al IFN-alfa.
    4. Embarazo o lactancia. Las pacientes deben ser estériles quirúrgicamente o posmenopáusicas, o estar de acuerdo en usar un método de contracepción efectivo durante el periodo de tratamiento. La definición de contracepción efectiva se basará en el juicio del investigador principal o la persona designada. Los pacientes hombres deben ser estériles quirúrgicamente o estar de acuerdo en usar un método contraceptivo efectivo.
    5. Otras enfermedades psiquiátricas o médicas severas, agudas o crónicas, o parámetros anormales de laboratorio que puedan incrementar el riesgo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que a juicio del investigador harían que el paciente no resultara adecuado para entrar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo primario de este protocolo es proporcionar acceso al tratamiento con SU011248 a pacientes con CCR metastásico de acuerdo a las condiciones descritas en el protocolo y sin prueba de hipótesis formal. Además, se evaluarán los siguientes criterios de valoración.
    • Perfil de seguridad de SU011248
    • Supervivencia global (SG)
    • Tiempo hasta la progresión (THP)
    • Supervivencia libre de progresión (SLP)
    • Tasa de respuesta objetiva (TRO)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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.8.3 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    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 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
    En todos los países participantes, el fin del ensayo se define como la última visita del último paciente.
    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 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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 5000
    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)
    Los pacientes pueden continuar en éste ensayo mientras experimenten beneficios con el tratamiento.
    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 Decision2005-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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