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   44335   clinical trials with a EudraCT protocol, of which   7366   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:2010-023400-28
    Sponsor's Protocol Code Number:INIPA_R_05219
    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:2010-12-20
    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 number2010-023400-28
    A.3Full title of the trial
    ENSAYO CLÍNICO RANDOMIZADO FASE II DE DOCETAXEL-CARBOPLATINO EN COMBINACIÓN CON INIPARIB (BSI-201), Y DOCETAXEL-CARBOPLATINO COMO TRATAMIENTO NEOADYUVANTE DE PACIENTES CON CÁNCER DE MAMA ESTADIO TEMPRANO Y FENOTIPO TRIPLE NEGATIVO
    A.4.1Sponsor's protocol code numberINIPA_R_05219
    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 Sponsorsanofi aventis groupe
    B.1.3.4CountryFrance
    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 nameINIPARIB (BSI-201)
    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.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
    TRATAMIENTO NEOADYUVANTE DE PACIENTES CON CÁNCER DE MAMA ESTADIO TEMPRANO Y FENOTIPO TRIPLE NEGATIVO
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio consiste en evaluar y clasificar la actividad antitumoral, determinada por medio de la tasa de respuesta completa patológica (RCp) en la mama y en los ganglios linfáticos axilares (RCp + CCR (Carga del Cáncer Residual) clase I de Symmans), del tratamiento neoadyuvante con docetaxel-carboplatino en combinación con iniparib o docetaxel-carboplatino en mujeres con cáncer de mama operable triple negativo.
    E.2.2Secondary objectives of the trial
    Evaluar en ambos brazos de tratamiento:
    La tasa de RCp en la mama y en los ganglios linfáticos axilares (Miller and Payne grado 5/tipo D)
    La tasa de RCp en la mama (Miller and Payne grado 5)
    La tasa de respuestas objetivas (TRO) en la mama por imagen radiológica
    La tasa de cirugías conservadoras de la mama
    La supervivencia libre de enfermedad infiltrante (SLEI)
    La supervivencia libre de enfermedad (SLE).
    Supervivencia Global (SG).
    Perfil de seguridad (NCI CTCAE v 4.03)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Caracterización molecular de las muestras de tumor,evaluación de biomarcadores y estudio de factores predictivos de respuesta al tratamiento. 24/10/10.Objetivos:1. Caracterización molecular de los fenotipos de cáncer de mama triple negativo que puedan definir una población con mayor susceptibilidad/resistencia.
    2.Correlacionar el perfil de expresión génica con la respuesta clínica o el resultado final con el objetivo de identificar la firma genética de sensibilidad...más información en Protocol
    E.3Principal inclusion criteria
    1. Mujeres con edad comprendida entre 18 y 72 años
    2. Consentimiento Informado de Pre-selección firmado por la paciente para confirmar el fenotipo triple negativo en un laboratorio central. El Consentimiento Informado para la entrada en el ensayo clínico también firmado por la paciente.
    3. Diagnóstico confirmado histológicamente de cáncer de mama primario, infiltrante y operable, estadios IIa-IIIc (6ª edición del AJCC Cancer Staging Manual), con tumores > 2 cm. En caso de un tumor multifocal (los focos del tumor localizados en el mismo cuadrante) la lesión mayor deberá ser > 2 cm y será designada como la lesión “diana” para las evaluaciones siguientes del tumor. El estado de CMTN será evaluado en dos de los focos incluyendo el mayor.
    4. Pacientes con fenotipo triple negativo: RE y RPg con menos del 10% de las células teñidas por IHQ, FISH negativo para la amplificación de HER2 (definido como una proporción de copias de Her-2/neu en centrómero [CEP17] del cromosoma 17 <2).
    5. Tener al menos una lesión medible en una dimensión por los criterios RECIST 1.1 (obligatorio una técnica de imagen: mamografía o ecografía de mama o RMN).
    6. Adecuado estado funcional (ECOG < 2).
    7. Adecuada función renal y hepática y reserva de la médula ósea.
    8. Las pacientes deberán estar accesibles para el tratamiento y seguimiento. Las pacientes registradas en este estudio deberán ser tratadas y seguidas en los centros participantes.
    E.4Principal exclusion criteria
    1.Cáncer de mama inflamatorio.
    2.Evidencia clínica o radiológica de enfermedad metastásica.
    3.Cáncer de mama multicéntrico o contralateral sincrónico o cáncer de mama infiltrante previo.
    4.Segundo tumor maligno primario, excepto un carcinoma in situ del cuello uterino, cáncer de colon estadio I, melanoma no infiltrante y carcinoma basocelular o espinocelular de piel, carcinoma ductal in situ (CDIS) ipsilateral de mama y carcinoma lobulillar in situ (CLIS) de mama, a menos que la neoplasia maligna previa haya sido diagnosticada y tratada de forma definitiva al menos 5 años antes sin indicios posteriores de recidiva.
    5.Tratamiento antineoplásico previo o concomitante para la enfermedad actual (hormonoterapia, quimioterapia, radioterapia, inmunoterapia).
    6.Tratamiento previo con docetaxel, cualquier inhibidor de PARP o carboplatino por cualquier tumor maligno.
    7.Contraindicación de los fármacos del estudio (docetaxel, carboplatino o INIPARIB).
    8.Tratamiento en los 30 días previos con un fármaco o a través de un dispositivo en investigación que no esté aprobado por las autoridades sanitarias en ninguna indicación en el momento de la entrada en el estudio.
    9.Trastorno sistémico concomitante grave que, en opinión del investigador, pondría en peligro la capacidad de la paciente de completar el estudio o cualquier otra enfermedad que podría empeorar con la quimioterapia u otros posibles tratamientos de apoyo.
    10.La paciente está embarazada o en período de lactancia o tiene previsto quedarse embarazada en los seis meses siguientes al final del tratamiento. En las mujeres en edad fértil: debe realizarse una prueba de embarazo en suero u orina en los 7 días previos a la aleatorización según las normas institucionales y utilizarse un método anticonceptivo adecuado durante el tratamiento con la medicación del estudio y en los seis meses siguientes al final del tratamiento.
    11.Mujeres potencialmente fértiles (con ultima menstruación en los últimos 2 años) sin uso efectivo, medidas no hormonales de contracepción (dispositivo contraceptivo intra-uterino, método de barrera con gel espermicida o esterilización quirúrgica) durante el estudio y por un periodo de 6 meses tras la última administración de los fármacos del estudio.
    El estado triple negativo será confirmado por un laboratorio central antes de la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Parámetros de eficacia:
    El criterio principal de eficacia es la evaluación de la tasa de respuesta completa patológica (RCp) en el momento de la cirugía de la mama y la axila siguiendo el método de Symmans realizado en un laboratorio central.
    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) 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 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 concerned41
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 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
    La definición del final del Ensayo se encuentra en el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 No
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 176
    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 Decision2011-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-20
    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 May 09 17:21:23 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA