Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-001307-33
    Sponsor's Protocol Code Number:VEG110727
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-18
    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 number2008-001307-33
    A.3Full title of the trial
    A randomized double blind phase III trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy.
    Ensayo fase III aleatorizado y doble ciego de pazopanib frente a placebo en pacientes con sarcoma de tejidos blandos cuya enfermedad ha progresado durante o tras tratamiento previo.
    A.3.2Name or abbreviated title of the trial where available
    PALETTE
    A.4.1Sponsor's protocol code numberVEG110727
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepazopanib
    D.3.2Product code GW786034
    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 INNPazopanib
    D.3.9.1CAS number 635702-64
    D.3.9.2Current sponsor codeGW786034B
    D.3.9.3Other descriptive namepazopanib hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepazopanib
    D.3.2Product code GW786034
    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 INNPazopanib
    D.3.9.1CAS number 635702-64
    D.3.9.2Current sponsor codeGW786034B
    D.3.9.3Other descriptive namepazopanib hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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
    Soft Tissue Sarcoma
    Sarcoma de tejidos blandos
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigar si el tratamiento con pazopanib mejora la situación de los pacientes con sarcoma de tejidos blandos metastásico, en comparación con placebo
    To investigate whether treatment with pazopanib improves the outcome of patients with metastatic soft tissue sarcoma, when compared to placebo.
    E.2.2Secondary objectives of the trial
    No aplicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Sarcoma de tejidos blandos (STB) de grado elevado o intermedio. Los tumores de grado bajo se admiten siempre que presentan progresión. Los tipos de tumores elegibles se enumeran en el capítulo 3.
    Antes de incluirse en el estudio, todos los pacientes necesitan tener progresión de la enfermedad confirmada. La evaluación radiológica ‘basal’ debe demostrar progresión de la enfermedad por criterios RECIST comparada con una evaluación previa realizada en los últimos 6 meses (o 12 meses para aquellos pacientes que únicamente recibieron tratamiento (neo-)adyuvante sistémico).
    2.- Enfermedad metastásica y no únicamente enfermedad localmente avanzada.
    3.- Enfermedad medible según criterios RECIST.
    4.- Los pacientes podrán haber recibido un máximo de 4 líneas de tratamientos sistémicos (incluyendo hasta 2 regímenes de combinación) para la enfermedad avanzada; en este criterio no se tienen en cuenta los tratamientos (neo-)adyuvantes ni de mantenimiento.
    La última dosis del tratamiento previo puede haberse administrado hasta 14 días antes del inicio del estudio, siempre que todas las toxicidades en curso de la terapia anticancerosa previa sean de grado 1 (excepto alopecia) o se hayan resuelto.
    los pacientes cuya enfermedad haya progresado* durante o después de un régimen basado en antraciclinas.
    los pacientes cuya enfermedad haya progresado* durante o después de las quimioterapias convencionales disponibles en el centro de tratamiento, salvo que estén médicamente contraindicadas o el paciente haya declinado recibirlas.
    los pacientes no podrán haber recibido tratamiento previo con inhibidores de la angiogénesis ni fármacos que actúan frente a VEGF o VEGFR. Se considera que los inhibidores mTOR no son inhibidores de la angiogénesis.
    * Nota: o los pacientes pueden no haber tolerado su último tratamiento.
    5.- Estado funcional de la OMS de 0 a 1
    6.- No toxicidad sin resolver del tratamiento anticanceroso previo que sea de grado >1 (excepto alopecia) o que esté progresando en severidad.
    7.- No antecedentes conocidos de metástasis leptomeníngeas o cerebrales.
    8.- Función normal de médula ósea, hepática, renal y cardiaca.
    9.- No podrán participar pacientes con hipertensión mal controlada (se define como tensión arterial mal controlada si es >150/90).
    10.- No antecedentes de anomalías gastrointestinales clínicamente significativas.
    11.- Serán descartados: los pacientes que hayan sufrido un accidente cerebrovascular en cualquier momento en el pasado, los pacientes que hayan sufrido un ataque isquémico transitorio en los 6 últimos meses y los pacientes que hayan padecido trombosis venosa profunda (TVP) o embolismo pulmonar en los 6 últimos meses.
    Nota: Podrán participar los pacientes con TVP reciente que hayan recibido tratamiento con anticoagulantes y que hayan permanecido estables durante 6 semanas como mínimo.
    12.- No evidencia de hemorragia activa ni diátesis hemorrágica.
    13.- No hemoptisis en las 6 semanas previas a la primera dosis del fármaco del estudio.
    Nota: Cualquier paciente con antecedentes de hemoptisis asociada a enfermedad metastásica deberá tener una broncoscopia que descarte lesiones endobronquiales. Un paciente con una lesión endobronquial será excluidos del estudio.
    14.- No intervenciones quirúrgicas mayores ni traumatismos importantes en los 28 días previos al inicio del tratamiento.
    15.- Restricción de las medicaciones concomitantes (véase el capítulo 5.8)
    16.- Anticoncepción
    17.- Consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. No antecedentes conocidos de metástasis leptomeníngeas o cerebrales
    2. No podrán participar pacientes con hipertensión mal controlada (una PA basal >150/90 se define como mal controlada)
    3. No antecedentes de trastornos gastrointestinales clínicamente significativos
    4. Se excluyen: los pacientes que hayan sufrido un accidente cerebrovascular en cualquier momento en el pasado, los pacientes que hayan sufrido un ataque isquémico transitorio en los 6 últimos meses y los pacientes que hayan padecido trombosis venosa profunda (TVP) o embolismo pulmonar en los 6 últimos meses. Nota: Podrán participar los pacientes con TVP reciente que hayan recibido tratamiento con anticoagulantes y que hayan permanecido estables durante 6 semanas como mínimo.
    5. No evidencia de hemorragia activa ni diátesis hemorrágica
    6. No hemoptisis en las 6 semanas previas a la primera dosis del fármaco del estudio. Nota: Cualquier paciente con antecedentes de hemoptisis asociada a enfermedad metastásica deberá tener una broncoscopia que descarte lesiones endobronquiales. Un paciente con una lesión endobronquial será excluido del estudio
    7. No intervenciones quirúrgicas mayores ni traumatismos importantes en los 28 días previos al inicio del tratamiento
    8. Uso de medicación concomitante prohibida (ver punto 5.8)
    9. Los pacientes no podrán haber recibido tratamiento previo con inhibidores de la angiogénesis ni fármacos que actúan frente a VEGF o VEGFR. Se considera que los inhibidores mTOR no son inhibidores de la angiogénesis.
    E.5 End points
    E.5.1Primary end point(s)
    La variable primaria es la supervivencia libre de progresión. La progresión se definirá según los criterios de RECIST
    Overall Progression Free Survival. Progression will be defined according to RECIST.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 estudio finalizará cuando se cumplan todas las condiciones siguientes:
    1. El reclutamiento en el ensayo está cerrado y en ese momento el último paciente presenta progresión de enfermedad o deja de recibir la medicación del estudio.
    2. El estudio está maduro para el análisis final de la variable principal definida en el protocolo.
    3. La base de datos ha sido limpiada y congelada para este análisis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 255
    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)
    Al finalizar el tratamiento del estudio los pacientes serán tratados por su médico según los criterios locales habituales.
    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 Decision2008-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-28
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 10:28:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA