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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-005887-97
    Sponsor's Protocol Code Number:MO19390
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-03
    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 number2005-005887-97
    A.3Full title of the trial
    Estudio abierto sobre bevacizumab(AVASTIN®) en combinación con quimioterapia basada en platino como tratamiento de primera línea de pacientes con carcinoma de pulmón no microcítico, no epidermoide, avanzado o recurrente

    Open-label study of bevacizumab (AVASTIN®) in combination with platinum-containing chemotherapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer.
    A.3.2Name or abbreviated title of the trial where available
    SAIL
    A.4.1Sponsor's protocol code numberMO19390
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAVASTIN
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMab, VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/4ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMab, VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400mg/16ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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 or recurrent non-squamous non-small cell lung cancer.

    Cáncer de pulmón no microcítico, no epidermoide, avanzado o recurrente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el perfil de seguridad de bevacizumab en combinación con quimioterapia como tratamiento de primera línea de CPNM, no epidermoide, avanzado ó recurrente. En particulaar, la incidencia de Acontecimientos adversos relacionados con bevacizumab y la incidencia de Acontecimientos Adversos graves y Principal: Evaluar el perfil de seguridad de bevacizumab cuando se combina con quimioterapia como tratamiento de primera línea del CPNM, no epidermoide, avanzado o recurrente.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de bevacizumab, medida como el tiempo hasta la progresión y la supervivencia global. Evaluar la seguridad de bevacizumab en pacientes que desarrollen metástasis en el sistema nervioso central (SNC) durante el período de tratamiento y en los 6 meses siguientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.1.Consentimiento informado por escrito (el documento de consentimiento informado deberá ser aprobado por el comité ético del centro, y deberá ser otorgado por el paciente antes de someterlo a cualquier procedimiento específico del estudio)
    2.Edad ≥18 años
    3.El paciente ha de ser capaz de cumplir el protocolo
    4.Cancer de Pulmón No Microcítico (demostrado histológica o citológicamente) inoperable, localmente avanzado (estadio IIIb, con metástasis en ganglios supraclaviculares o con derrame maligno pleural o pericárdico), metastásico (Estadio IV) o recurrente, que no sea epidermoide (los tumores de histología mixta se clasificarán por el tipo de célula predominante).
    5.Estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0-2.
    6.Esperanza de vida ≥12 semanas
    7.Función hematológica adecuada:
    - Recuento absoluto de neutrófilos (RAN) ≥1,5 x 109/l Y
    - Recuento de plaquetas ≥100 x 109/l Y
    - Hemoglobina ≥9 g/dl (se permite hacer transfusiones para mantener o superar este nivel)
    8.Función hepática adecuada:
    - Bilirrubina total < 1,5 x límite superior de la normalidad (LSN) Y
    - Asparagina aminotransferasa (AST), alanina aminotransferasa (ALT) <2,5 x LSN en pacientes sin metástasis hepáticas; <5 x LSN en pacientes con metástasis hepáticas
    9.Función renal adecuada:
    - Creatinina sérica ≤1,25 x LSN o aclaramiento de creatinina calculado ≥50 ml/min Y
    - Proteinuria <2+ medida con tira reactiva. Si en la prueba con tira reactiva realizada en la visita basal se descubre que la proteinuria es ≥2+, se obtendrá una muestra de orina de 24 horas en la que la cantidad de proteínas deberá ser ≤1 g
    10. Cociente internacional normalizado (INR) ≤1,5 y tiempo de protrombina (TPT) ≤1,5 x LSN en los 7 días previos a la inclusión
    11. En el caso de las mujeres, no podrán estar embarazadas ni lactantes. Las mujeres con útero intacto (a menos que presenten amenorrea en los últimos 24 meses) deberán dar negativo en una prueba de embarazo en suero realizada en los 28 días previos a la inclusión en el estudio. Si no se realiza una prueba de embarazo en suero en los 7 días previos a la administración de la primera dosis de bevacizumab, habrá que obtener una prueba de confirmación en orina (en los 7 días previos a la administración de la primera dosis de bevacizumab)
    E.4Principal exclusion criteria
    1. Tumores microcíticos y no microcíticos mixtos, o carcinomas adenoepidermoides mixtos con predominio del componente epidermoide
    2. Antecedentes de hemoptisis, definida como la emisión de al menos media cucharadita de sangre roja y brillante en los 3 meses previos a la inclusión
    3. Evidencia mediante técnicas de imagen de que el tumor invade vasos sanguíneos importantes. El investigador o el radiólogo local deberán descartar la posibilidad de que el tumor se encuentre contiguo en su totalidad a la luz de una vaso sanguíneo importante (p. ej., arteria pulmonar o vena cava superior), rodeándolo o entrando en la luz del mismo.
    4. Evidencia de metástasis en el SNC, ni aunque haya sido tratada previamente En caso de sospecha, se obtendrá un escáner en los 28 días previos a la inclusión para descartar las metástasis en el SNC.
    5. Quimioterapia neoadyuvante/adyuvante en los 6 meses previos a la inclusión.
    6. Radioterapia en los 28 días previos a la inclusión.
    7. Cirugía mayor (incluida la biopsia abierta) o lesión traumática significativa en los 28 días previos a la inclusión, o previsión de que se necesitará cirugía mayor durante el tratamiento del estudio.
    8. Cirugía menor, incluida la inserción de una sonda permanente, en las 24 horas previas a la primera infusión de bevacizumab.
    9. Uso de ácido acetilsalicílico (>325 mg/día) en la actualidad o recientemente (en los 10 días previos a la administración de la primera dosis de bevacizumab).
    10. Uso en la actualidad o recientemente (en los 10 días previos a la administración de la primera dosis de bevacizumab) de dosis completas de anticoagulantes o trombolíticos por vía oral o parenteral, con fines terapéuticos Se permite el uso profiláctico de anticoagulantes.
    11. Antecedentes o evidencia de diátesis hemorrágica o coagulopatía hereditarias, con riesgo de hemorragia.
    12. Hipertensión no controlada (presión arterial: sistólica >150 mm Hg y/o diastólica >100 mm Hg).
    13. Enfermedades cardiovasculares clínicamente significativas (es decir, activas), por ejemplo ACV (≤6 meses antes de la inclusión), infarto de miocardio (≤6 meses antes de la inclusión), angina inestable, insuficiencia cardíaca congestiva de clase ≥2 de la NYHA, arritmia cardíaca grave que requiera medicación durante el estudio y pueda interferir en la regularidad del tratamiento del estudio, o que no se controle con medicación.
    14. Herida que no cicatriza, úlcera péptica activa o fractura ósea.
    15. Antecedentes de fístula abdominal, perforación gastrointestinal o absceso intraabdominal en los 6 meses previos a la inclusión.
    16. Mujeres con útero intacto (a menos que presenten amenorrea en los últimos 24 meses) que no utilicen métodos anticonceptivos no hormonales eficaces (dispositivo intrauterino, método de barrera junto con gelatina espermicida o esterilización quirúrgica) durante el estudio y al menos durante los 6 meses siguientes a la administración de la última dosis de bevacizumab. Varones que no acepten utilizar métodos anticonceptivos eficaces durante el estudio y al menos durante los 60 días siguientes a la administración de la última dosis de bevacizumab.
    17. Tratamiento con cualquier otro producto experimental, o participación en otro ensayo clínico en los 28 días previos a la inclusión.
    18. Hipersensibilidad conocida a bevacizumab o a cualquiera de sus excipientes, y a cualquiera de las quimioterapias.
    19. Demostración de cualquier otra enfermedad neurológica o disfunción metabólica, hallazgo en la exploración física o hallazgo de laboratorio que suponga una sospecha razonable de la existencia de una enfermedad o trastorno que contraindique el uso de un fármaco experimental, o que suponga para el paciente un riesgo elevado de complicaciones relacionadas con el tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de acontecimientos adversos graves (AAG) y no graves (AA no G) relacionados con bevacizumab. Se obtendrá información adicional sobre acontecimientos adversos (AA) de especial interés (graves y no graves) como hipertensión, proteinuria, complicaciones en la cicatrización de las heridas, perforaciones gastrointestinales, tromboembolias arteriales y venosas, hemoptisis, hemorragias en el SNC, otras hemorragias e insuficiencia cardíaca congestiva. Todos los AA serán evaluados con arreglo a los criterios de terminología común para AA del National Cancer Institute(NCI CTC-AE versión 3.0).
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned38
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA300
    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
    Un año despues del reclutamiento del último paciente, o cuando todos los pacientes hayan fallecido.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-03. 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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1650
    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 Decision2006-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-30
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