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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:2007-001346-41
    Sponsor's Protocol Code Number:ICON6
    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:2011-06-10
    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 number2007-001346-41
    A.3Full title of the trial
    Ensayo clínico multicéntrico del Gynaecologic Cancer Intergroup, controlado doble ciego de Cediranib (AZD 2171), en combinación con quimioterapia basada en platino y como agente único en terapia de mantenimiento, en mujeres con cáncer de ovario que han recaído más de 6 meses tras la finalización de un tratamiento de primera línea basado en platino.
    A.3.2Name or abbreviated title of the trial where available
    ICON6
    A.4.1Sponsor's protocol code numberICON6
    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 Investigación en Cáncer de Ovario (GEICO)
    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 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.3.2Product code AZD2171
    D.3.4Pharmaceutical form Film-coated 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 INNcediranib
    D.3.9.1CAS number 288383-20-0
    D.3.9.2Current sponsor codeAZD2171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    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.3.2Product code AZD2171
    D.3.4Pharmaceutical form Film-coated 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 INNcediranib
    D.3.9.1CAS number 288383-20-0
    D.3.9.2Current sponsor codeAZD2171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Carcinoma epitelial de ovario, trompas de Falopio o peritoneal seroso primario que precisen quimioterapia basada en platino por una primera recidiva posterior a 6 meses después de la última dosis de tratamiento de primera línea basado en platino.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 seguridad y eficacia de AZD2171 en combinación con quimioterapia basada en platino y como agente único en terapia de mantenimiento, en mujeres con cáncer de ovario en recidiva después de más de 6 meses de la finalización del tratamiento de primera línea basado en platino.
    E.2.2Secondary objectives of the trial
    Evaluar supervivencia global y libre de progresión, toxicidad y calidad de vida en el estadio 3 del ensayo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Investigación traslacional (farmacogenómica y biomarcadores). Este subestudio forma parte del protocolo del estudio principal (de igual fecha y versión). Los objetivos principales son: evaluar si es posible identificar los biomarcadores que identifican los pacientes que más se beneficiarán del tratamiento con AZD2171, para minimizar costes y toxicidad. Evaluar si es posible identificar marcadores de progresión clínica temprana durante el tratamiento definido en el protocolo.
    E.3Principal inclusion criteria
    1.Mujeres de  18 años de edad con diagnóstico previo demostrado histológicamente de:
    -Carcinoma epitelial ovárico
    -Carcinoma de las trompas de Falopio
    -Carcinoma peritoneal seroso primario
    que precise tratamiento con quimioterapia adicional basada en platino 6 meses después de su último ciclo de quimioterapia de primera línea y 6 semanas después de mantenimiento no basado en quimioterapia.
    2.Consentimiento informado firmado y capacidad para cumplir el protocolo
    3.Posibilidad de comenzar tratamiento en aproximadamente1 las 2 semanas siguientes a la aleatorización
    4.Enfermedad recidivante demostrada por TC o RM (medible o no medible)
    5.Estado funcional ECOG de 0-13
    6.Esperanza de vida superior a 12 semanas
    7.Si existen antecedentes de un tumor sólido (distinto de cáncer ovárico), deberá haberse sometido a tratamiento curativo hace más de cinco años sin signos de recurrencia; se exceptúan las pacientes con cáncer de endometrio (estadio I G1, G2) sincrónico con el cáncer de ovario
    8.En caso de tratamiento previo con antraciclinas o radioterapia torácica, fracción de eyección del ventrículo izquierdo (FEVI) > límite inferior normal del centro
    9.Función adecuada de la médula ósea:
    -Recuento absoluto de neutrófilos (RAN)  1,5 x 109/l
    -Recuento de plaquetas (Plt)  100 x 109/l
    -Hemoglobina (Hb)  9 g/dl (puede ser después de transfusión)
    10.Función hepática adecuada (en los 14 días previos a la aleatorización)
    -Bilirrubina sérica (BR)  1,5 x LSN
    -Transaminasas séricas  2,5 x LSN4
    11.Función renal adecuada
    -Creatinina sérica  1,5 LSN o aclaramiento de creatinina calculado >50 ml/min
    -Proteinuria en tira reactiva <2+. Si la tira reactiva indica una proteinuria  2+ en dos ocasiones separadas por más de una semana, una determinación en orina de 24 horas deberá mostrar  1 g de proteína en 24 horas o un cociente proteína/creatinina < 1,5.
    E.4Principal exclusion criteria
    1.Cáncer ovárico no epitelial, incluidos tumores mullerianos mixtos malignos y carcinoma mucinoso del peritoneo.
    2.Hipotensión mal controlada (elevación persistente > 150/100 mmHg de la presión sistólica, diastólica o ambas a pesar de medicación antihipertensiva)
    3.Antecedentes de enfermedad intestinal inflamatoria (enfermedad de Crohn o colitis ulcerosa)
    4.Neoplasias malignas distintas del cáncer de ovario en los 5 años previos a la aleatorización, excepto cáncer endometrial (estadio I G1, G2) sincrónico con cáncer de ovario, carcinoma in situ del cuello uterino o cáncer de piel basocelular adecuadamente tratados. Las pacientes con antecedentes de tumor sólido hace mas de 5 años (antes de la aleatorización), tratadas curativamente y sin signos de recurrencia son elegibles para participar en el ICON6
    5.Radioterapia previa en aproximadamente los 21 días previos al comienzo previsto del tratamiento.
    6.Tratamiento con cualquier otro producto en investigación en las 6 semanas previas a la entrada en este ensayo. Las pacientes son elegibles para la inclusión en el ICON6 si han recibido tratamiento previo para el cáncer ovárico con bevacizumab, erlotinib o un inhibidor de la Cox-2, siempre que hayan transcurrido más de 6 semanas desde el último tratamiento
    7.Episodio trombótico arterial (incluidos accidente isquémico transitorio [AIT], accidente cerebrovascular [ACV] y embolia arterial periférica) en los 12 meses previos.
    8.Trastorno digestivo que pueda afectar a la capacidad de ingerir o a la absorción de medicación oral, incluida la obstrucción intestinal subaguda o completa
    9.Hipersensibilidad conocida al cediranib o a otros inhibidores del VEGF
    10.Cirugía mayor en las 2 semanas previas al inicio previsto del tratamiento
    11.Hemorragia importante > 30 ml en un solo episodio en los 3 últimos meses o cualquier hemoptisis
    12.Signos de cardiopatía grave o no controlada
    Infarto de miocardio (IM) o angina inestable en los 12 meses previos
    Insuficiencia cardíaca congestiva (ICC) de grado  2 de la New York Health Association (NYHA1)
    Arritmias ventriculares cardíacas que requieran medicación
    Antecedentes de defectos de conducción auriculoventriculares de segundo o tercer grado
    13.Intervalo QTc (corregido) prolongado > 470 ms en el ECG, o antecedentes familiares de síndrome de QT largo.
    14.Toxicidad de grado  2 persistente según los CTC (excepto alopecia y neuropatía) debida a tratamiento previo antineoplásico. Si existe neuropatía periférica sensitiva o motriz de 1.grado  2, puede omitirse paclitaxel de la quimioterapia a criterio del médico tratante
    15.Antecedentes o sospecha clínica de metástasis cerebrales o compresión de la médula espinal. Si se sospechan metástasis cerebrales, es obligatorio realizar TC/RM del cerebro. Es obligatoria una RM espinal en caso de sospecha de compresión de la médula espinal. Las pacientes con metástasis inestables cerebrales o meníngeas no tratadas no son elegibles
    16.Imposibilidad de acudir o cumplir el tratamiento o el programa de seguimiento
    17.Indicios de cualquier otra enfermedad, disfunción metabólica, hallazgo en la exploración física o en análisis que suscite una sospecha razonable de una enfermedad o circunstancia que contraindique el uso de un fármaco en investigación o ponga a la paciente en riesgo alto de sufrir complicaciones relacionadas con el tratamiento
    18.Mujeres en edad fértil que no estén dispuestas a utilizar un método anticonceptivo adecuado durante la totalidad del tratamiento del ensayo y hasta al menos 6 meses después
    19.Cualquier otra condición clínica o enfermedad grave no controlada
    20.Uso concomitante de inhibidores potentes de la CYP3A4 y 2C8 que no puedan retirarse sin un período de lavado de 2 semanas antes de instaurar el producto en investigación (véase la sección 6.3 para más detalles)
    E.5 End points
    E.5.1Primary end point(s)
    Fase 1: seguridad
    Fase 2: supervivencia libre de progresión
    Fase 3: supervivencia global
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    calidad de vida, investigación traslacional
    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 Yes
    E.8.1.7.1Other trial design description
    multi-brazos, multi-etapas
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    El ensayo se considerará cerrado cuando los datos sobre la supervivencia general son lo suficientemente maduros para una primera publicación. Se espera que esto ocurra unos dos años después del reclutamiento del último paciente (suponiendo que la duración del período de reclutamiento es de 4 años).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 No
    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 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 2011-06-10. Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1570
    F.4.2.2In the whole clinical trial 2000
    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 Decision2011-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-30
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