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    Summary
    EudraCT Number:2012-002745-38
    Sponsor's Protocol Code Number:GEIS-30
    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:2012-07-26
    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 number2012-002745-38
    A.3Full title of the trial
    Phase II Clinical Trial of Pazopanib to evaluate the activity and tolerability in patients with advanced and/or metastatic liposarcoma who have relapsed following standard therapies or for whom no standard therapy exists
    Ensayo clínico fase II de Pazopanib para evaluar la actividad y tolerabilidad en pacientes con liposarcoma avanzado y/o metastásico que han recaído a la terapia estándar o en aquellos en los cuales no existe terapia estándar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Activity and tolerability of Pazopanib in advanced and/or metastatic liposarcoma. A phase II clinical trial.
    Actividad y tolerabilidad de Pazopanib en liposarcoma avanzado y/o metastásico. Ensayo clínico Fase II
    A.4.1Sponsor's protocol code numberGEIS-30
    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 SponsorGrupo Español de Investigación en Sarcomas
    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 supportGEIS
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportGSK
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSecretaría GEIS
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street AddressSecretari Coloma, 64-68, esc. B, entlo. 5ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number34934344412
    B.5.5Fax number34932531168
    B.5.6E-mailfederico.nepote@mfar.net
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Film-coated 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 INNPazopanib
    D.3.9.1CAS number 444731-52-C
    D.3.9.2Current sponsor codePR1
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced and/or metastatic liposarcoma
    Liposarcoma avanzado y/o metastásico
    E.1.1.1Medical condition in easily understood language
    Advanced and/or metastatic liposarcoma
    Liposarcoma avanzado y/o metastásico
    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 PT
    E.1.2Classification code 10024629
    E.1.2Term Liposarcoma metastatic
    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 PT
    E.1.2Classification code 10024627
    E.1.2Term Liposarcoma
    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
    The primary objective of this study is to evaluate the activity of Pazopanib in patients with advanced and/or metastatic liposarcoma by means of progression-free survival (PFS) assessed 12 weeks after start of treatment. (According the RECIST criteria 1.1 and central radiology review).
    El objetivo primario de este estudio es evaluar la actividad de Pazopanib en pacientes con liposarcoma avanzado y/o metastásico mediante la supervivencia libre de progresión (SLP) determinada a las 12 semanas tras el inicio del tratamiento (de acuerdo a criterios RECIST 1.1 y revisión radiológica central).
    E.2.2Secondary objectives of the trial
    Median progression-free survival (median PFS)
    Objective tumor response (confirmed complete response [CR] and partial response [PR] using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
    Time to onset of response
    Duration of response
    Overall survival (OS)
    Clinical benefit rate (CBR)
    Growth Modulation Index (GMI).
    Safety profile (according CTCAE, version 4.0)
    Supervivencia libre de progresión mediana (PFS mediana)
    Respuesta tumoral objetiva [Respuesta completa confirmada (CR) y respuesta parcial (PR) definidas mediante RECIST 1.1]
    Tiempo hasta inicio de la respuesta
    Duración de la respuesta
    Supervivencia global (OS)
    Tasa de beneficio clínico (TBC)
    Indice de modulación de crecimiento (GMI)
    Perfil de seguridad (según CTCAE, versión 4.0)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PRIMARY OBJECTIVES:
    To evaluate the influence of the angiogenic status of the tumor on the response to Pazopanib.
    To evaluate the serum profile of serum cytokine markers as indicator of response to Pazopanib.

    SECONDARY OBJECTIVES:
    To evaluate microvessel density (MVD) and p53, MDM2, PTEN and VEGF/PDGF pathways by IHQ expression and their correlation with prognosis as well as their role as predictive factors to treatment with Pazopanib (Response, PFS and OS).
    To evaluate serum levels of several angiogenic factors/cytoquines using Luminex XMAP Technology at baseline, after the first 3 weeks of treatment, at maximum response and at progression and their predictive value for survival and response to treatment: VEGF-A, PlGF-1, SDF-1 alpha (CXCL12), TNF alpha, IL-8, IL-6, PDGF ?beta, HGF, E- Selectine, ICAM1, MMP-9 and FGFb.
    To analyse PIK3CA mutations in order to demonstrate if those liposarcomas with PIK3CA mutations defines a subgroup of patients with differential response to Pazopanib.
    OBJETIVOS PRIMARIOS:
    Evaluar la influencia del estado angiogénico del tumor en la respuesta a Pazopanib.
    Evaluar el perfil de citoquinas séricas como indicador de respuesta a Pazopanib.

    OBJETIVOS SECUNDARIOS:
    Evaluar la densidad de microvasos (DMV) y las vías de p53, MDM2, PTEN y VEGF/PDGF por inmunohistoquímica, su correlación con el pronóstico y su papel como factores predictivos al tratamiento con Pazopanib (respuesta, PFS y OS).
    Evaluar niveles séricos de varios factores angiogénicos/citoquinas usando Luminex XMAP Technology a nivel basal, tras las 3 primeras semanas de tratamiento, en el momento de respuesta máxima y en la progresión tumoral y su valor predictivo para supervivencia y respuesta al tratamiento: VEGF-A, PlGF-1, SDF-1 alfa (CXCL12), TNF alfa, IL-8, IL-6, PDGF?beta, HGF, E- Selectina, ICAM1, MMP-9 y FGFb.
    Analizar la presencia de mutaciones en PIK3CA para demostrar si aquellos liposarcomas con mutaciones en PIK3CA definen un subgrupo de pacientes con diferente respuesta a Pazopanib.
    E.3Principal inclusion criteria
    1.Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
    2.Age ? 18 years or legal age of consent if greater than 18 years
    3.Histological confirmed diagnosis of high or intermediate grade malignant liposarcoma with metastatic or locally advanced disease. Formaline fixed paraffin embedded tumour block and/or representative H/E (haematoxylin/eosin) slides must be available for central pathologic review.
    4.Patient must have documentation of disease progression within 6 months prior to study entry.
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    6.Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area. If the only measurable lesion is in a previously irradiated area, RECIST progression should be documented after radiotherapy, in the previous 6 months before study entry.
    7.The patient should not be considered eligible for surgery or radical radiotherapy. e.g. Patients to whom surgery/radiotherapy can not be performed with a curative intent due to the extension of the disease. In the case of radiotherapy, it may also be limited due to a previous treatment with radiotherapy in the same area.
    8.The patient must have either been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory or metastatic disease. A maximum of three previous lines for advanced/metastatic disease are allowed.
    9.The patient should be able to swallow and retain study drug
    10.Adequate organ system function as defined in Table 1 of protocol.
    11.A subject is eligible to enter and participate in this study if she/he is following the contraceptive indication detailed in protocol.
    12.LVEF above the lower limit of normal for the institution, based on ECHO or MUGA.
    1.Los sujetos deben dar su consentimiento informado antes de la realización de cualquiera de las evaluaciones o procedimientos del estudio y deben estar dispuestos a cumplir con el tratamiento y el seguimiento establecido.
    2.Edad ? 18 años.
    3.Diagnóstico histológico de liposarcoma de grado intermedio o alto de malignidad con enfermedad metastásica o localmente avanzada. Se debe disponer de bloque tumoral fijado en parafina y/o laminillas con cortes representativos teñidas con H/E (hematoxilina/eosina) para su revisión patológica central
    4.Los pacientes deben presentar progresión de la enfermedad documentada en los 6 meses previos a la entrada del paciente en el estudio.
    5.Eastern Cooperative Oncology Group (ECOG) performance status de 0-1.
    6.Enfermedad medible por criterios RECIST v1.1. Debe existir al menos una lesión medible localizada fuera de un área previamente irradiada. Si la única lesión medible se encuentra en un área previamente irradiada, debe existir progresión documentada tras la radioterapia en los 6 meses previos a la entrada del paciente en el estudio.
    7.El paciente no debe ser considerado candidato para cirugía o para recibir radioterapia radical. Ej. Pacientes en los que la cirugía/radioterapia no puede tener una intención curativa por la extensión de la enfermedad. En el caso de la radioterapia, puede estar limitada por irradiación previa sobre la misma zona.
    8.El paciente debe haber sido considerado no candidato para quimioterapia sistémica o bien debe haber recibido al menos una línea de quimioterapia para enfermedad metastásica o refractaria. Se permite hasta un máximo de 3 líneas previas para enfermedad avanzada/metastásica. Se requiere disponer de tejido tumoral de todos los sujetos para estudio de biomarcadores antes/durante el tratamiento con el fármaco en estudio.
    9.El paciente debe ser capaz de tragar y retener la medicación de estudio.
    10. Función de órganos y sistemas adecuada, tal y como se define en la Tabla 1 del protocolo.
    11. Un sujeto es elegible para el ensayo si sigue las indicaciones contraceptivas indicadas en el protocolo.
    12.Fracción de eyección del ventrículo izquierdo (FEVI) por encima del límite inferior de normalidad para la institución, ya sea por ecocardiograma o MUGA.
    E.4Principal exclusion criteria
    1.Prior history of malignancies other than liposarcoma.
    Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
    2.History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
    3.Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
    4.Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
    5.Corrected QT interval (QTc) > 480 msecs
    6.History of any one or more of cardiovascular conditions within the past 6 months.
    7.Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ?140 mmHg or diastolic blood pressure (DBP) of ? 90mmHg].
    8.History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
    Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
    9.Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
    10.Evidence of active bleeding or bleeding diathesis.
    11.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
    Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
    12.Recent hemoptysis (? ½ teaspoon of red blood within 8 weeks before first dose of study drug).
    13.Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject?s safety, provision of informed consent, or compliance to study procedures.
    14.Unable or unwilling to discontinue use of prohibited medications listed in section 7.4 of this protocol or at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
    15.Treatment with any of the following anti-cancer therapies:
    radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of Pazopanib
    chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Pazopanib
    16.Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
    17.Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
    1.Historia previa de otras neoplasias malignas diferentes al liposarcoma.
    Los pacientes que han presentado una neoplasia previa y se encuentran libres de enfermedad durante al menos 3 años, así como aquellos que presentan historia de tumor cutáneo no melanomatoso completamente extirpado o de carcinoma in situ correctamente tratado, son elegibles.
    2.Evidencia clínica de metástasis a nivel del sistema nervioso central o carcinomatosis leptomeníngea, excepto aquellos pacientes que han sido tratados, se encuentran asintomáticos y no han requerido tratamiento con corticoides o anticomiciales en los 6 meses previos a la administración de la primera dosis del fármaco de estudio. Sólo se requiere CT o MRI del sistema nervioso central como parte de las pruebas de selección si está clínicamente indicado o si el paciente tiene historia previa de metástasis a nivel del sistema nervioso central.
    3.Alteraciones gastrointestinales clínicamente significativas que pueden aumentar el riesgo de sangrado digestivo.
    4.Alteraciones gastrointestinales que pueden afectar la absorción del fármaco.
    5.Intervalo QT corregido (QTc) > 480 msecs
    6.Historia de cualquiera de enfermedades cardiovasculares en los últimos 6 meses.
    7.Hipertensión mal controlada [definida como presión arterial sistólica (SBP) ?140 mmHg o presión arterial diastólica (DBP) ? 90mmHg].
    8.Historia de accidente cerebrovascular (incluyendo accidente cerebrovascular transitorio ? TIA), tromboembolismo pulmonar o trombosis venosa profunda no tratada en los últimos 6 meses. Los pacientes con una DVT reciente que han sido tratados con anticoagulantes durante, al menos, 6 semanas, son elegibles.
    9.Cirugía mayor o traumatismo en los 28 días previos a la primera dosis de la medicación de estudio y/o presencia de cualquier herida, fractura o úlcera que no cicatrice (la colocación de catéter y similares no se considera cirugía mayor).
    10. Evidencia de sangrado activo o diátesis hemorrágica.
    11. Lesiones endobronquiales conocidas y/o lesiones que infiltran grandes vasos pulmonares que aumenten el riesgo de hemorragia pulmonar.
    Se excluyen los pacientes con lesiones que infiltran los grandes vasos pulmonares; sin embargo, los pacientes con una lesión tumoral que toca pero que no infiltra los vasos son elegibles (se recomienda CT con contraste para valorar estas lesiones).
    12. Hemoptisis reciente (? ½ cucharilla de sangre roja durante las 8 semanas previas a la primera dosis del fármaco).
    13.Cualquier condición médica o psiquiátrica grave o inestable preexistente, así como cualquier otra situación que pueda interferir con la seguridad o el cumplimiento del sujeto o con su capacidad para dar su consentimiento informado.
    14.Incapacidad o negativa del paciente para suspender las medicaciones prohibidas que se enumeran en la sección 7.4 de este protocolo o para abandonarlas durante los 14 días previos o durante 5 vidas medias (lo que sea mayor) a la primera dosis del fármaco y durante todo el tratamiento de estudio.
    15.Tratamiento con cualquiera de los siguientes fármacos antineoplásicos:
    Radioterapia, cirugía o embolización tumoral durante los 14 días previos a la primera dosis de pazopanib, O
    Quimioterapia, inmunoterapia, tratamiento biológico, fármacos en investigación o terapia hormonal durante los 14 días previos o durante 5 vidas medias (lo que sea mayor) a la primera dosis del Pazopanib
    16. Administración de cualquier medicación no oncológica en investigación durante los 30 días previos o durante 5 vidas medias (lo que sea mayor) a la primera dosis del fármaco de estudio.
    17. Cualquier toxicidad > grado 1 de tratamientos antineoplásicos previos y/o que esté progresando en gravedad, excepto la alopecia.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point of the study is progression free survival 12 weeks after start of therapy, measured as a binary variable.
    La variable primaria de eficacia es la supervivencia libre de progresión 12 semanas después del inicio del tratamiento, calculada como una variable binaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be based on the disease evaluation performed 12 weeks after start of treatment with central radiology review. Patients who are alive and progression free at this time will be considered as successes. Patients who have progressed or are dead at this time will be considered as failure. Patients with an unknown progression status will be considered as failure. The diagnosis of progression should be based on tumor measurements, according to the RECIST 1.1 criteria.
    Se basará en la valoración de la enfermedad que se realizará a las 12 semanas después del inicio del tratamiento con una revisión radiológica central. Los pacientes que estén vivos y sin evidencia de progresión en este momento se considerarán como éxitos, y los que hayan progresado o muerto en este momento se considerarán como fracasos del tratamiento. Los pacientes en los cuales se desconozca si existe o no progresión se considerarán también como fracasos. El diagnóstico de progresión debe basarse en las medidas de las lesiones tumorales, de acuerdo con los criterios RECIST 1.1.
    E.5.2Secondary end point(s)
    Overall progression free survival (median PFS)
    Objective tumor response
    Time to onset of response
    Duration of response
    Overall survival (OS)
    Clinical benefit rate
    Growth Modulation Index (GMI)
    Safety profile (according CTCAE, version 4.0)
    Supervivencia libre de progresión global (PFS)
    Tasa de respuestas objetiva
    Tiempo hasta el inicio de respuesta
    Duración de respuesta
    Supervivencia global (OS)
    Tasa de beneficio clínico
    Índice de modulación de crecimiento (GMI).
    Perfil de seguridad (según CTCAE, versión 4.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease should be captured and target/non-target identified at baseline by CT or MRI as appropriate. Subsequently, imaging studies required to investigate known disease should be repeated every 6 weeks for the first 12 weeks and every 8 weeks thereafter until disease progression or new anticancer therapy among others.
    Assessment of adverse events will include type, incidence, severity, timing, seriousness, and relatedness; and laboratory abnormalities. In each study visit all adverse events will be registered according to NCI-CTC version 4.0
    La enfermedad debe ser capturada por TAC o RMN, según sea más apropiado, y las lesiones target/no-target deben ser identificadas.Posteriormente, los estudios de imagen necesarios para conocer el estado de la enfermedad deben repetirse cada 6 semanas durante las primeras 12 semanas y después cada 8 semanas hasta progresión o nuevo tratamiento antineoplásico entre otras.
    La descripción de los efectos adversos incluirá tipo, incidencia, gravedad, momento de aparición, severidad y causa relacionada; y las anormalidades de parámetros de laboratorio.
    En cada visita de estudio todos los efectos adversos deberán ser registrados según los criterios NCI-CTC versión 4.0.
    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 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 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.8.4.1Number 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 EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LPLV. The study will be considered closed from a normative point of view after data on primary and secondary variables are sufficiently prepared for its initial publication.
    UPUV. El ensayo se considerará cerrado desde el punto de vista normativo después de que los datos sobre las variables primarias y secundarias estén lo suficientemente preparados como para su publicación inicial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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 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.1.2.1Number of subjects for this age range: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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)
    Treatment of Normal Clinical Practice for study disease
    Tratamiento de práctica clínica habitual para la enfermedad a estudio.
    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 Decision2012-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-02
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