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    Summary
    EudraCT Number:2010-019255-22
    Sponsor's Protocol Code Number:EFC11553
    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:2010-09-02
    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 number2010-019255-22
    A.3Full title of the trial
    Ensayo aleatorizado de Fase III de gemcitabina/carboplatino con o sin BSI-201 (SAR240550) (un inhibidor de PARP1) en pacientes con cáncer de pulmón no microcítico (CPNM) epidermoide en estadío IV no tratado previamente
    __________________________________________________

    Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)
    A.4.1Sponsor's protocol code numberEFC11553
    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 SponsorBiPar Sciences, Inc.
    B.1.3.4CountryUnited States
    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.3.2Product code SAR240550 (BSI-201)
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeSAR240550 (BSI-201)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name Gemzar 200mg powder for solution for infusion, Gemzar 1g powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderLilly Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder 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 INNGEMCITABINE HYDROCHLORIDE
    D.3.9.1CAS number 122111-03-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 3
    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 Carboplatin 10 mg/ml Intravenous Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecarboplatin
    D.3.4Pharmaceutical form 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.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cáncer de pulmón no microcítico
    _______________________________________

    Squamous Non Small Cell Lung Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la supervivencia global (SG) de los pacientes con CPNM epidermoide en estadío IV que reciben gemcitabina/carboplatino con o sin BSI-201.
    ______________________________________________

    To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without BSI-201.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son evaluar lo siguiente en los pacientes con CPNM epidermoide en estadío IV que reciben gemcitabina/carboplatino con o sin BSI-201:
    - Supervivencia sin progresión (SSP)
    - Tiempo hasta la progresión (THP)
    - Tasa de respuesta objetiva (TRO)
    - Seguridad y tolerabilidad de la pauta de tratamiento
    - Calidad de vida determinada mediante EORTC QLQ-30 y QLQ-LC13
    _________________________________________________

    To evaluate the following in patients with advanced squamous cell lung cancer receiving gemcitabine/carboplatin either with or without BSI-201:
    ?Progression free survival (PFS)
    ?Time to progression (TTP)
    ?Objective response rate (ORR)
    ?Safety and tolerability of the treatment regimen
    ?Quality of life as measured by EORTC QLQ-30 and QLQ-LC13
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El objetivo del subestudio es evaluar potenciales marcadores biológicos para la predecir la eficacia del tratamiento. Se recogerán muestras de sangre y de tejido para el análisis genético del ADN y/o ARN.
    ______________________________________________

    The objective of the study is to evaluate potential biomarkers for predicting treatment efficacy. Blood samples and tumor tissue will also be collected for DNA and/or RNA genetic testing.
    E.3Principal inclusion criteria
    Los pacientes elegibles deben cumplir los siguientes criterios para ser incluidos en el estudio:
    1. CPNM epidermoide en estadío IV de nuevo diagnóstico. Esto incluye a los pacientes que se presentan con metástasis diseminadas, y a aquellos con derrame pleural o pericárdico neoplásico (o sea, anterior estadío IIIB del 6º sistema de estadiaje TNM).
    2. Pacientes que han recibido terapia adyuvante previa para el cáncer de pulmón en estadío precoz si han transcurrido al menos 12 meses desde dicho tratamiento.
    3. Carcinoma broncogénico epidermoide confirmado histológicamente. Los pacientes cuyos tumores contienen histologías no microcíticas mixtas son elegibles mientras el carcinoma epidermoide sea la histología predominante. Los tumores mixtos con elementos anaplásicos microcíticos no son elegibles. Las muestras citológicas obtenidas mediante cepillado, lavado o aspiración con aguja de la lesión definida son aceptables.
    4. Los pacientes con radioterapia previa como terapia definitiva para el cáncer de pulmón no microcítico localmente avanzado son elegibles mientras que la recidiva esté fuera del campo de la radioterapia original. La radioterapia debe haberse finalizado >4 semanas antes de la fecha de la firma del Consentimiento Informado.
    5. Presencia de enfermedad evaluable (medible o no medible).
    6. Estado Funcional ECOG de 0 o 1 (véase el Apéndice A).
    7. Siguientes valores de laboratorio:
    • Recuento absoluto de neutrófilos (ANC) >1,500/microL y plaquetas >100,000/microL (&#8804;72 horas antes del tratamiento inicial).
    • Hemoglobina >9 g/dl (Nota: Los pacientes pueden recibir transfusiones o eritropoyetina para mantener o superar este nivel).
    • Bilirrubina < LSN.
    • Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) &#8804;2,5 veces el límite superior normal si no hay afectación hepática o &#8804;5 veces el límite superior normal si hay afectación hepática.
    • Creatinina <2,0 mg/dl o aclaramiento de creatinina >40 ml/min (calculado mediante el método de Cockcroft-Gault (véase la Sección 8.3.3).
    8. Las mujeres potencialmente fértiles deben tener una prueba de embarazo en suero negativa realizada en los 7 días previos al comienzo del tratamiento. Las mujeres potencialmente fértiles o los hombres con parejas potencialmente fértiles deben usar medidas de control de natalidad efectivas durante el tratamiento y al menos 3 meses tras la última dosis del tratamiento del estudio. Si una mujer se queda embarazada o sospecha que está embarazada mientras está participando en este estudio, debe acceder a informar inmediatamente al médico que la trata.
    9. >18 años de edad.
    10. Capacidad para comprender la naturaleza de este estudio, otorgar el consentimiento informado por escrito y cumplir con los requisitos del estudio.
    11. Los pacientes incluidos en este estudio deben estar dispuestos a proporcionar tejido de una biopsia previa del tumor (si está disponible) para análisis correlativo. Un paciente será elegible para su inclusión en el estudio aunque el tejido no esté disponible.
    E.4Principal exclusion criteria
    Los pacientes elegibles no deben tener los siguientes criterios para ser incluidos en el estudio:
    1. Tratamiento previo con gemcitabina, carboplatino (excepto como terapia adyuvante) o BSI 201.
    2. Historia pasada o actual de neoplasia aparte del diagnóstico de inclusión, excepto cáncer cutáneo no melanoma o carcinoma in-situ del cuello uterino tratados, u otros cánceres curados mediante terapia local sólo y con una supervivencia sin enfermedad de >5 años.
    3. Historia de enfermedad cardiaca, definida por:
    - Hipertensión maligna
    - Angina inestable
    - Insuficiencia cardiaca congestiva
    - Infarto de miocardio en los 6 meses previos
    - Arritmias cardiacas sintomáticas
    4. Metástasis cerebrales activas. Los pacientes con metástasis cerebrales tratadas son elegibles si (1) la radioterapia se finalizó al menos 2 semanas antes de la inclusión en el estudio; (2) las pruebas radiológicas de seguimiento no muestran progresión de la enfermedad; y (3) el paciente no necesita esteroides.
    5. Mujeres embarazadas o dando lactancia materna.
    6. Cualquier infección activa grave (> grado 2) en el momento del tratamiento.
    7. Trastorno médico subyacente que afectaría a la capacidad del paciente para recibir el tratamiento del protocolo.
    8. Procedimiento quirúrgico mayor, biopsia abierta o lesión traumática &#8804;28 días antes del comienzo del tratamiento, o previsión de la necesidad de cirugía mayor durante el transcurso del estudio.
    9. Enfermedad no controlada o intercurrente incluyendo, entre otras, infección activa o continuada, insuficiencia cardiaca congestiva sintomática, angina de pecho inestable o arritmia cardiaca.
    10. Historia de cualquier trastorno médico o psiquiátrico o alteración de laboratorio que, según la opinión del investigador, pueda aumentar los riesgos asociados con la participación en el estudio o con la administración de los productos en investigación, o que pueda interferir con la interpretación de los resultados.
    11. Alergia/hipersensibilidad conocida o sospechada a cualquier fármaco administrado en el transcurso de este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    supervivencia global (SG)
    ____________________________

    Overall survival (OS)
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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 concerned8
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male 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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 825
    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 Decision2010-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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