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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2006-001354-28
    Sponsor's Protocol Code Number:D4200C00068
    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:2006-05-31
    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 number2006-001354-28
    A.3Full title of the trial
    “Estudio fase II abierto, para valorar la eficacia y tolerabilidad de ZD6474 (ZACTIMA® ) 100 mg en Monoterapia en pacientes con Cáncer de Tiroides Medular Hereditario Metastásico o Localmente Avanzado"
    A.4.1Sponsor's protocol code numberD4200C00068
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/344
    D.3 Description of the IMP
    D.3.1Product nameZACTIMA
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form Tablet
    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 INNvandetanib
    D.3.9.1CAS number 338992-00-0
    D.3.9.2Current sponsor codeZD6474
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/344
    D.3 Description of the IMP
    D.3.1Product nameZACTIMA
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form Tablet
    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 INNvandetanib
    D.3.9.1CAS number 338992-00-0
    D.3.9.2Current sponsor codeZD6474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Cáncer de tiroides medular hereditario
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este ensayo es determinar la tasa de respuesta objetiva en pacientes tratados con 100 mg de ZD6474 en monoterapia.
    E.2.2Secondary objectives of the trial
    Determinar:
    Seguridad y tolerabilidad del tratamiento con ZD6474
    Supervivencia libre de progresión (SLP) en pacientes con CTM hereditario con 100 mg de ZD6474
    Tasa de control de la enfermedad (CE), la duración de la respuesta objetiva y la duración del control de la enfermedad con ZD6474
    Si el tratamiento con ZD6474 produce un descenso de la frecuencia de las deposiciones en pacientes con diarrea sintomática asociada al CTM hereditario (“respuesta sintomática”)
    Valorar:
    Cambios en el estado funcional (EF) en pacientes tratados con ZD6474, comparando con los valores basales, empleando el EF de la OMS
    Efecto de 100 mg de ZD6474 en los niveles de CTN y de CEA.
    Caracterizar:
    Farmacocinética de la población (FC) de ZD6474 en pacientes con CTM hereditario.
    Relación FC-FD entre la exposición a ZD6474 y los cambios en la prolongación de QTc, acontecimientos adversos (AA), respuesta, SLP, y los cambios en los niveles de CTN y de antígeno carcinoembrionario (CEA)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito
    2. Mujeres o varones de edad igual o superior a 18 años
    3. Confirmación histológica previa del diagnóstico de carcinoma de tiroides medular hereditario localmente avanzado o metastático, sin otras opciones terapéuticas habituales. Debe aportarse documentación de la historia médica del paciente
    4. Esperanza de vida igual o superior a 12 semanas
    5. EF de la OMS 0-2
    6. Una o más lesiones medibles con un diámetro mayor de al menos 10 mm mediante TC helicoidal (grosor de la sección de 5 mm) o de 20 mm mediante técnicas convencionales (>5 mm de grosor de la sección) según los criterios RECIST
    7. Prueba negativa de embarazo en las mujeres en edad fértil. Las mujeres deberán llevar un año en postmenopausia, estar esterilizadas quirúrgicamente o utilizar un método anticonceptivo aceptable. Los hombres deberán estar esterilizados quirúrgicamente o utilizar un método anticonceptivo aceptable durante su participación en el ensayo.
    E.4Principal exclusion criteria
    1. Metástasis cerebrales o compresión de la médula espinal, a no ser que se le haya tratado con radioterapia al menos 4 semanas antes de la primera dosis y que se encuentre estable sin tratamiento de esteroides por ≥1 semana
    2. La última dosis de la quimioterapia previa se administró menos de 4 semanas antes del inicio del tratamiento del ensayo.
    3. La última radioterapia se ha aplicado en las 4 semanas previas al inicio del tratamiento del ensayo.
    4. Cirugía mayor en las 4 semanas anteriores o incisión quirúrgica no cicatrizada completamente antes de iniciar el tratamiento del ensayo.
    5. Cualquier toxicidad no resuelta >grado 2 de los CTCAE por tratamiento antitumoral previo
    6. Bilirrubina sérica >1,5 x LSIR
    7. Creatinina sérica >1,5 x LSIR o aclaramiento de creatinina ≤50 ml/minuto (calculado por la fórmula de Cockcroft-Gault)
    8. Alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) o fosfatasa alcalina >2,5 veces x LSIR si no hay metástasis hepáticas demostrables, o >5 x LSIR si el investigador considera que está relacionado con metástasis hepáticas.
    9. Episodio cardiovascular importante (p. ej., infarto de miocardio, síndrome de vena cava superior [VCS], clasificación de cardiopatía ≥2 según la New York Heart Association [véase el apéndice J] en los 3 meses anteriores a la inclusión o presencia de cardiopatía que, en opinión del investigador, aumente el riesgo de arritmia ventricular.
    10. Antecedentes de arritmia (extrasístoles ventriculares [EV] multifocales, bigeminismo, trigeminismo, taquicardia ventricular o fibrilación auricular no controlada) que es sintomática o que requiere tratamiento (grado 3 de los CTCAE) o de taquicardia ventricular sostenida asintomática. Se permiten los sujetos con fibrilación auricular controlada con medicación.
    11. Síndrome de QT prolongado congénito o algún familiar en primer grado fallecido por muerte súbita inexplicable con una edad inferior a los 40 años
    12. Prolongación de QT con otra medicación que exigió la retirada de ésta
    13. Presencia de bloqueo de rama izquierda (BRI)
    14. QTc con corrección de Bazett no medible o ≥480 ms o más en el ECG de selección (Nota: si el sujeto tiene un intervalo QTc ≥480 ms en el ECG de selección, éste podrá repetirse dos veces). El valor de QTc del ECG, o del promedio de los ECG si se realiza más de uno, debe ser < 480 ms para que el paciente sea elegible para el ensayo.
    15. Potasio <4,0 mmol/l a pesar del uso de suplementos; calcio sérico (ionizado o ajustado en función de la albúmina) o magnesio fuera del intervalo normal a pesar del uso de suplementos
    16. Mujeres embarazadas o lactantes (mujeres en edad fértil)
    17. Cualquier medicamento concomitante que pueda afectar al QTc o inducir la función de CYP3A4 (a excepción de la somatostatina o de la somatostatina análoga) y/o las medicaciones prohibidas del Apéndice E y de la sección 3.8.
    18. Hipertensión no controlada con el tratamiento médico (presión arterial sistólica >160 milímetros de mercurio [mm Hg] o presión arterial diastólica >100 mg Hg).
    19. Procesos malignos previos o actuales en otras localizaciones en los últimos 5 años, a excepción del carcinoma de cérvix in situ y del carcinoma basocelular o escamocelular de la piel tratados adecuadamente
    20. Evidencia de enfermedad sistémica grave o incontrolada o de cualquier proceso simultáneo que, en opinión del investigador, desaconseje la participación del paciente en el ensayo o pondría en peligro el cumplimiento del protocolo
    21. Reclutamiento previo en este estudio o reclutamiento previo en tratamientos con ZD6474 de estudios previos.
    22. Participación en la planificación y realización del ensayo (se aplica al personal tanto de AstraZeneca como del centro de investigación)
    23. Tratamiento con un fármaco en investigación o no aprobado en los 30 días previos al inicio del tratamiento del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta objetiva
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.2Open No
    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.8.5The 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 Information not present in EudraCT
    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 final del ensayo se define como la fecha de cierre de la base de datos, que es el momento a partir del cual ningún paciente estará expuesto a actividades relacionadas con el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-31. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 15
    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 Decision2006-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-30
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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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