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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2008-002320-29
    Sponsor's Protocol Code Number:XL184-301
    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:2008-10-31
    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 number2008-002320-29
    A.3Full title of the trial
    Estudio internacional, aleatorizado, doble ciego, de fase 3 para evaluar la eficacia
    de XL184 frente a placebo en pacientes con cáncer medular tiroideo, no extirpable,
    localmente avanzado o metastásico

    An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
    A.4.1Sponsor's protocol code numberXL184-301
    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 SponsorExelixis, Inc.
    B.1.3.4CountryUnited States
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXL184
    D.3.2Product code XL184
    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.3.9.2Current sponsor codeXL184
    D.3.9.3Other descriptive nameXL184
    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: 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXL184
    D.3.2Product code XL184
    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.3.9.2Current sponsor codeXL184
    D.3.9.3Other descriptive nameXL184
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cáncer medular tiroideo

    Medullary thyroid carcinoma (MTC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10055107
    E.1.2Term Thyroid cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la supervivencia libre de progresión (PFS) con tratamiento de XL184 frente a placebo en pacientes con cáncer medular tiroideo (MTC) no extirpable, localmente avanzado o metastásico.
    E.2.2Secondary objectives of the trial
    Evaluar:
    - La supervivencia total con el tratamiento de XL184 comparado con placebo
    - La tasa de respuesta objetiva y la duración de la respuesta en pacientes con enfermedad medible con tratamiento de XL184 comparado con placebo, según los criterios de evaluación de respuesta modificada en tumores sólidos
    - Los cambios en los niveles séricos de calcitonina y antígeno carcinoembriónico como biomarcadores de pronóstico del beneficio del tratamiento de XL184 comparado con placebo
    - La posible relación entre la línea germinal RET y/o la alteración de la secuencia de ADN del tumor y eficacia de XL184
    - Los efectos farmacodinámicos de XL184
    - La seguridad y tolerancia del tratamiento con XL184
    - La farmacocinética de XL184
    El objetivo exploratorio de este estudio es:
    - Evaluar los parámetros de autoevaluación del paciente y la carga sintomática con el tratamiento de XL184 en comparación con un placebo, según el módulo de tiroides del Cuestionario de síntomas MD Anderson
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. El paciente tiene un diagnóstico confirmado histológicamente de MTC no extirpable, localmente avanzado o metastásico, y la enfermedad es medible o no medible mediante mRECIST.
    2. El paciente tiene por lo menos 18 años.
    3. El paciente tiene un estado funcional ECOG (grupo de oncología cooperativa occidental) = ó < 2.
    4. El paciente padece una enfermedad progresiva documentada (PD) con tomografía computerizada (TC), escaneo óseo mediante imagen por resonancia magnética (IRM) o rayos X (confirmada mediante el comité de revisión independiente [IRC] central y ciego) según mRECIST en la selección en comparación con una imagen previa realizada en un plazo de 14 meses desde la selección.
    5. El paciente se ha recuperado del grado v3.0 = ó < 1 dentro de los criterios comunes de terminología para acontecimientos adversos (CTCAE) del Instituto nacional para el cáncer (NCI) de acontecimientos adversos clínicamente significativos debido a agentes anti-neoplásicos, fármacos de investigación u otras medicaciones que fueran administradas antes de la aleatorización.
    6. El paciente presenta la siguiente función de órganos y medular: recuento absoluto de neutrofilo = ó > 1500/mm3, plaquetas = ó > 100.000/mm3, hemoglobina = ó > 9 g/dL, bilirrubina = ó < 1,5 veces el límite superior del valor normal (no se aplica a pacientes con síndrome de Gilbert), creatinina sérica = ó < 1,5 mg/dL, y alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) = ó < 2,5 veces el límite superior del valor normal
    7. Los pacientes sexualmente activos deben comprometerse a utilizar métodos médicamente aceptados de contracepción durante el transcurso del estudio y durante 3 meses después de la interrupción de los tratamientos del estudio (excluyéndose a las mujeres que no presentan potencial reproductor y a los hombres que han sido esterilizados).
    8. El paciente no tiene otro diagnóstico de cáncer (a menos que sea cáncer de piel no melanoma, carcinoma in situ del cérvix o un cáncer diagnosticado = ó > 2 años anteriormente) y actualmente no presenta síntomas de cáncer (a menos que sea cáncer de piel no melanoma, carcinoma in situ del cérvix).
    9. Las pacientes mujeres con potencial reproductor deben dar negativo en una prueba de embarazo en la selección. Las mujeres con potencial reproductor se definen: como aquellas mujeres sexualmente maduras sin histerectomía anterior o que hayan tenido cualquier evidencia de menstruación en los últimos 12 meses. Sin embargo, las mujeres que hayan sido amenorréicas durante 12 meses o más siguen siendo consideradas como con potencial reproductor si la amenorrea puede deberse a una quimioterapia anterior, antiestrógenos o supresión de ovarios.
    E.4Principal exclusion criteria
    1. El paciente ha recibido terapia antitumoral sistémica anterior (por ej. quimioterapia, modificadores biológicos o terapia antiangiogénica) dentro de las 4 semanas después de la aleatorización (6 semanas para nitrosoureas o mitomicina C).
    2. El paciente ha recibido radiación en = ó > 25 % de la médula espinal.
    3. El paciente ha recibido tratamiento con otros agentes de investigación dentro de las 4 semanas después de la aleatorización.
    4. El paciente ha recibido tratamiento con XL184.
    5. El paciente tiene metástasis cerebral o compresión del cordón espinal, a menos que haya completado radioterapia = ó > 4 semanas antes de la aleatorización y estable sin esteroides y sin tratamiento anticonvulsivo durante = ó > 10 días.
    6. El paciente presenta un historial de hematemesis clínicamente significativa o un historial reciente de hemoptisis de > 2,5 mL de glóbulos rojos u otros signos indicativos de hemorragia pulmonar o evidencia de lesiones endobronquiales.
    7. El paciente tiene una proporción de proteína/creatinina en orina de = ó > 1 (informada como gramos de proteína sobre gramos de creatinina).
    8. El paciente padece una enfermedad intercurrente grave, como hipertensión (dos o más lecturas de tensión arterial realizadas en la selección de > 140 mmHg en sistólica o > 90 mmHg en diastólica) a pesar de un tratamiento óptimo, heridas no curadas de cirugía reciente o arritmias cardiacas; o un historial reciente de enfermedad grave como insuficiencia cardiaco-congestiva sintomática o angina de pecho inestable en los últimos 3 meses, o infarto de miocardio, accidente cerebrovascular o ataque isquémico transitorio en los últimos 6 meses.
    9. La paciente está embarazada o en período de lactancia.
    10. El paciente padece una infección activa que requiera tratamiento sistémico.
    11. El paciente sufre una alergia conocida o hipersensibilidad a alguno de los componentes de las formulaciones del XL184 o placebo.
    12. El paciente es incapaz de comprender y cumplir el protocolo o no puede prestar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es la duración de la supervivencia sin progresión.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 EEA53
    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
    Observar al menos 217 fallecimientos para evaluar la supervivencia total (OS) como una variable secundaria clave.

    Se requiere un total de 217 fallecimientos para aportar el 80 % de potencia para detectar una mejora del 50% en la OS (HR = 0,667) usando la prueba log-rank y un nivel de significancia bilateral del 4 %.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 315
    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 Decision2009-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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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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