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    Summary
    EudraCT Number:2010-021163-33
    Sponsor's Protocol Code Number:ICR-CTSU/2010/10027
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-04-17
    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 number2010-021163-33
    A.3Full title of the trial
    A Phase II Trial of Cediranib in the Treatment of Patients with Alveolar Soft Part Sarcoma (CASPS)
    Ensayo fase II de Cediranib en el tratamiento de pacientes con sarcoma de partes blandas alveolar (CASPS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of a drug called Cediranib in the treatment of patients with a type of cancer called alveolar soft part sarcoma
    Ensayo clínico fase II del medicamento Cediranib en el tratamiento de pacientes con cáncer tipo sarcoma alveloar de partes blandas
    A.3.2Name or abbreviated title of the trial where available
    CASPS
    CASPS
    A.4.1Sponsor's protocol code numberICR-CTSU/2010/10027
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN63733470
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01337401
    A.5.4Other Identifiers
    Name:Trial codeNumber:CCR448
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Institute of Cancer Research / The Royal Marsden NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSofpromed
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressRambla dels Ducs, 13-1º
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07003
    B.5.3.4CountrySpain
    B.5.4Telephone number34648414261
    B.5.5Fax number34971570222
    B.5.6E-mailensayos@sofpromed.com
    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 nameCediranib
    D.3.2Product code AZD2171
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 Maleate
    D.3.9.4EV Substance CodeSUB26524
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboTablet
    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
    Alveolar soft part sarcoma
    Sarcoma alveolar de partes blandas
    E.1.1.1Medical condition in easily understood language
    Alveolar sarcoma cancer type of soft parts of the body
    Tipo de cáncer sarcoma alveolar de las partes blandas del cuerpo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10001883
    E.1.2Term Alveolar soft part sarcomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To measure the percentage change in the size of patient's tumours after 24 weeks of treatment (or at the time of disease progression if this is sooner) in patients taking cediranib, compared to those taking a placebo.
    Medir el porcentaje de cambio de tamaño de los tumores de los pacientes después de 24 semanas de tratamiento (o en el momento de la progresión de la enfermedad si es antes) en pacientes que toman cediranib, comparado con aquellos que toman placebo.
    E.2.2Secondary objectives of the trial
    ? To measure the response rate of patients after 24 weeks of treatment (this is the percentage of patients having a complete response to treatment, a partial response to treatment or stable disease. The different types of 'response' described are defined by specific criteria in a standard document called RECIST v1.1). Also, to measure the best response seen and the best reduction in tumour size for each patient.
    ? To measure progression-free survival (this is the length of time the patient's cancer does not get worse); also to measure the percentage of patients who are alive and progression-free at 12 months (this is the percentage of patients who at 12 months are still alive and their cancer has not got worse).
    ? To measure the overall survival of patients, which measures how long each patient survives, regardless of the stage of their disease.
    ? To evaluate how safe and how well tolerated cediranib is in patients with ASPS
    ? Medir índice de respuesta después de 24 semanas de tratamiento (porcentaje de pacientes que tienen una respuesta completa al tratamiento, respuesta parcial al tratamiento o enfermedad estable. Los diferentes tipos de "respuesta" se definen en un documento estándar llamado RECIST v1.1). También, medir la mejor respuesta observada y la mejor reducción en tamaño de tumor para cada paciente.
    ? Medir supervivencia libre de progresión (este es el periodo de tiempo en el que el cáncer del paciente no empeora); también medir el porcentaje de pacientes que están vivos y libres de progresión a los 12 meses (este es el porcentaje de pacientes que a los 12 meses siguen vivos y su cáncer no ha empeorado).
    ? Medir la supervivencia global de los pacientes, que mide cuánto tiempo sobrevive el paciente, independientemente de la fase de su enfermedad.
    ? Evaluar la seguridad y tolerancia del cediranib en pacientes con sarcoma alveolar de partes blandas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Histologically confirmed diagnosis of ASPS
    2.Age 16 years and older
    3.Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
    4.ECOG Performance Status of 0-1
    5.Life expectancy of >12 weeks
    6.Progressive disease within 6 months prior to randomisation
    7.Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by spiral CT (or MRI for brain metastases).
    8.Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant 9.The capacity to understand the patient information sheet and ability to provide written informed consent
    10.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
    11.Able to swallow and retain oral medication
    1.Diagnóstico histológico confirmado de sarcoma alveolar de partes blandas
    2.Edad 16 años o más
    3.Disponibilidad de bloques de tejido archivado o unstained slides para confirmación de traslocación t(X;17)
    4.ECOG Performance Status: 0-1
    5.Esperanza de vida >12 semanas
    6.Enfermedad progresiva en 6 meses antes de randomización
    7.Enfermedad metastásica medible según RECISTv1.1, ej: al menos una lesión de 10 mm de diámetro (15 mm en eje corto para lesiones nodales) evaluable por TAC espiral (o RMN para metástasis cerebral).
    8.Pacientes con metástasis se permiten si la enfermedad está controlada con una dosis estable de corticoesteroide y/o no-enzima induciendo anticonvulsivante
    9.La capacidad para entender la hoja de información al paciente y la habilidad para proporcionar el consentimiento informado escrito
    10.Voluntad y habilidad para cumplir con las visitas programadas, planes de tratamiento, pruebas de laboratorio y otros procedimientos del estudio
    11.Capacidad de tragar y retener medicación oral
    E.4Principal exclusion criteria
    1.Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ?1.5 x 109/L or platelet count ?100 x 109/L.
    2.Serum bilirubin ? 1.5 x ULN (unless Gilbert?s syndrome).
    3.ALT or AST ? 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN.
    4.Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of ? 50mL/min calculated.
    5.Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5.
    6.History of significant gastrointestinal impairment, as judged by the Investigator,that would significantly affect the absorption of cediranib. 7.Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy.
    8.Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection.
    9.Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/?RR) or history of familial long QT syndrome. 10.Significant recent haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks).
    11.Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed.
    12.Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised).
    13.Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving the last study treatment.
    14.History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for symptom control.
    15.Known hypersensitivity to cediranib or any of its excipients.
    16.History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion.
    17.Other concomitant anti-cancer therapy (including LHRH agonists) except steroids.
    18.Recent history of thrombosis.
    19.Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active bleeding, or those causing uncontrolled seizures.
    1.Reserva de médula ósea inadecuada con un número absoluto de neutrófilos ?1.5 x 109/L o plaquetas ?100 x 109/L
    2.Bilirrubina en suero ? 1.5 x ULN (a excepción de síndrome Gilbert)
    3.ALT o AST ? 2.5 x ULN. Si metástasis de hígado, ALT o AST > 5 x ULN
    4.Creatinina en suero > 1.5 x ULN or creatinina clearance (calculada o medida) de ? 50mL/min calculada
    5.Proteinuria mayor que +1 a menos que proteína urinaria < 1.5g en un periodo de 24h o proteína/creatinina ratio < 1.5.
    6.Historial de discapacidad gastrointestinal significativa, a juicio del investigador, que afectaría significativamente la absorción de cediranib
    7.Pacientes con historia de hipertensión pobremente controlada con presión sanguínea en reposo >150/100 mmHg en la presencia o ausencia de un régimen estable de terapia anti-hipertensión
    8.Cualquier evidencia de co-morbidades severas o no controladas, como enfermedad respiratoria, cardiaca, hepática o renal inestable o no compensada, o infección activa y no controlada
    9.Evidencia de QTc prolongado >480 msec (usando corrección Bazetts, cuya fórmula es: QTc = QT/?RR) o historia de síndrome QT largo familiar
    10.Hemorragia reciente significativa (>30mL sangrado/episodio en 3 meses previos) o hemoptisis (>5mL sangre fresca en 4 semanas previas)
    11.Cirugías torácicas o abdominales importantes en los 14 días previos a la entrada en el estudio, o incisión quirúrgica no completamente sanada
    12.Mujeres embarazadas o en lactancia; test de embarazo previo a recibir medicación; con intenciones de embarazo durante tratamiento; mujeres no dispuestas a hacer un test de embarazo de orina o suero antes de la entrada en el estudio (incluso con esterilización quirúrgica).
    13.Hombres y mujeres en edad fértil no dispuestos a usar medidas de control adecuadas (abstinencia, anticonceptivos orales, dispositivo intrauterino, método de barrera con espermicida, anticonceptivos implantables o inyectables o esterilización quirúrgica) por la duración del estudio, y debería continuar las precauciones por 2 semanas después de recibir el último tratamiento del estudio.
    14.Historia de tratamiento antineoplásico (incluyendo investigacional, no registrado) en las cuatro semanas anteriores a la primera dosis de cediranib, con la excepción de radioterapia paliativa para control de síntomas.
    15.Hipersensibilidad conocida a cediranib o a cualquiera de sus excipientes.
    16.Historia de otras malignidades (excepto para carcinoma espinocelular o carcinoma in situ adecuadamente tratado en basal) en 5 años, a menos que paciente ha estado libre de enfermedad por 2 años y existe diagnóstico de tejido del cáncer primario de interés de una lesión diana.
    17.Otra terapia antineoplásica concomitante (incluyendo agonistas LHRH) excepto esteroides.
    18.Historia reciente de trombosis.
    19.Pacientes con metástasis cerebrales si son sintomáticas requiriendo esteroides en incremento en las seis semanas previas a la entrada del estudio o aquellos con evidencia de sangrado reciente y/o activo, o aquellos causantes de convulsiones descontroladas.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in tumour size from randomisation to week 24 (or progression if sooner) compared to treatment with placebo.
    Evaluar la eficacia de cediranib en el tratamiento del sarcoma alveolar de partes blandas midiendo el porcentaje de cambio en tamaño de tumor desde randomización a la semana 24 (o progresión si ocurre antes) comparado con el tratamiento con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 from randomisation
    Semana 24 desde randomización
    E.5.2Secondary end point(s)
    1) To measure the response rate of patients after 24 weeks of treatment (this is the percentage of patients having a complete response to treatment, a partial response to treatment or stable disease. The different types of 'response' described are defined by specific criteria in a standard document called RECIST v1.1). Also, to measure the best response seen and the best reduction in tumour size for each patient.
    2) To measure progression-free survival (this is the length of time the patient's cancer does not get worse); also to measure the percentage of patients who are alive and progression-free at 12 months (this is the percentage of patients who at 12 months are still alive and their cancer has not got worse).
    3) To measure the overall survival of patients, which measures how long each patient survives, regardless of the stage of their disease.
    4) To evaluate how safe and how well tolerated cediranib is in patients with ASPS
    1) Medir índice de respuesta después de 24 semanas de tratamiento (porcentaje de pacientes que tienen una respuesta completa al tratamiento, respuesta parcial al tratamiento o enfermedad estable. Los diferentes tipos de "respuesta" se definen en un documento estándar llamado RECIST v1.1). También, medir la mejor respuesta observada y la mejor reducción en tamaño de tumor para cada paciente.
    2) Medir supervivencia libre de progresión (este es el periodo de tiempo en el que el cáncer del paciente no empeora); también medir el porcentaje de pacientes que están vivos y libres de progresión a los 12 meses (este es el porcentaje de pacientes que a los 12 meses siguen vivos y su cáncer no ha empeorado).
    3) Medir la supervivencia global de los pacientes, que mide cuánto tiempo sobrevive el paciente, independientemente de la fase de su enfermedad.
    4) Evaluar la seguridad y tolerancia del cediranib en pacientes con sarcoma alveolar de partes blandas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 24 weeks
    2) 12 months
    3) Long term
    4) Different stages of the study
    1) 24 semanas
    2) 12 meses
    3) Largo plazo
    4) Diferentes fases del estudio
    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 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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Las primeras 24 semanas son doble ciego, después todos los pacientes pasan a cediranib (open label).
    First 24 weeks are double blind, then all patients cross over to open label cediranib.
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    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
    The end of the interventional period of the trial is defined as 30 days after the last trial participant receives the last dose of the investigational medicinal product. However patients will continue to be followed up for survival after this time point.
    El final del periodo de intervención del ensayo se define como 30 días después de que el último participante del ensayo reciba la última dosis del producto medicinal en investigación. Sin embargo los pacientes serán seguidos para supervivencia posteriormente.
    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 Yes
    F.1.1Number of subjects for this age range: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 36
    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)
    Patients will continue on cediranib treatment until disease progression, i.e. until they are no longer receiving any benefit from treatment. Patients continued care will be at the discretion of their treating physician once they are off study. Drug supply is provided until 2015.
    Los pacientes continuarán el tratamiento con cediranib hasta progresión de la enfermedad, esto es, hasta que no reciban ningún beneficio del tratamiento. El cuidado continuado del paciente quedará a discreción del médico una vez acabado el estudio. El fármaco será suministrado hasta 2015.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Grupo Español de Investigación en Sarcomas (GEIS)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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