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   43873   clinical trials with a EudraCT protocol, of which   7293   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:2011-000853-22
    Sponsor's Protocol Code Number:CA184-162
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-29
    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 number2011-000853-22
    A.3Full title of the trial
    A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer.

    Protocol Amendment 01-Pharmacogenetics Blood Sample Amendment (dated 12-Jan-2012), site specific, and administrative letter 01dated 07-Feb-2012
    Protocol Amendment 02: Biomarker substudy (dated 12-Jan-2012), site specific
    Ensayo fase II, abierto, aleatorizado y con dos grupos, para comparar la eficacia del
    tratamiento secuencial con ipilimumab frente al mejor tratamiento de soporte después de
    quimioterapia de primera línea en sujetos con cáncer gástrico o de la unión
    gastroesofágica irresecable y localmente avanzado/metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy study in gastric and gastroesophageal junction cancer comparing ipilimumab versus standard of care immediately following first line chemotherapy
    A.4.1Sponsor's protocol code numberCA184-162
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    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 nameIPILIMUMAB
    D.3.2Product code BMS-734016 / MDX010
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016 / MDX010
    D.3.9.3Other descriptive nameIPILIMUMAB
    D.3.9.4EV Substance CodeSUB29397
    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 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) 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 Yes
    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
    Locally advanced (unresectable) or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
    cáncer gástrico o de la unión gastroesofágica irresecable y localmente avanzado/metastásico.
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    cáncer gástrico
    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 10030137
    E.1.2Term Oesophageal adenocarcinoma
    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 10017758
    E.1.2Term Gastric cancer
    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 purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
    El objetivo del estudio es comparar la eficacia del tratamiento secuencial con ipilimumab frente al mejor tratamiento de soporte después de quimioterapia de primera línea en sujetos con cáncer gástrico o de la unión gastroesofágica irresecable y localmente avanzado/metastásico.
    E.2.2Secondary objectives of the trial
    ? progression free survival (PFS) per modified WHO criteria,
    ? Overall survival (OS),
    ? immune-related best overall response rate (irBORR),
    ?Comparar la SLP según los criterios OMSm.
    ?Comparar la supervivencia global (SG).
    ?Comparar la tasa de mejor respuesta global relacionada con el sistema inmunitario (TMRGri).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    (1) Pharmacogenetics Blood Sample Amendment Number 01 - Site
    Specific (dated 12-Jan-2012)
    The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use
    DNA obtained from the blood sample and health information collected from the main clinical trial, CA184162 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of gastric cancer and other cancers. Samples from this study may also be used in conjunction with pharmacogenetic research results from other clinical studies to
    accomplish this objective.

    (2) Protocol Amendment 02: Biomarker substudy (dated 12-Jan-2012)
    The experiments outlined in this amendment to the CA184162 phase II trial aim to provide understanding of ipilimumab activity in the clinic and to generate data that may impact the use of ipilimumab for the treatment of gastric cancer patients.

    Exploratory Objective 1 - To identify and/or confirm PD biomarkers measured in blood specimens that establish biological activity of ipilimumab used sequentially following first-line chemotherapy for gastric cancer patients.
    Exploratory Objective 2: To identify and/or confirm the prognostic or predictive value of efficacy and safety biomarkers measured in baseline blood specimens obtained from gastric cancer patients receiving ipilimumab.

    Sample collection will be completed for all subjects enrolled at sites permitting the biomarker studies outlined herein.
    Enmienda sobre muestras de sangre para Farmacogenética Número 01
    Específica de centro de fecha 12 de enero de 2012.
    El objetivo de esta enmienda es permitir la recogida y la conservación de muestras de sangre para uso en estudios de investigación farmacogenética exploratorios futuros. Bristol-Myers Squibb usará el ADN obtenido de la muestra de sangre y la información de salud recogida del cuaderno de recogida de datos del ensayo clínico principal, CA184162 para estudiar la asociación entre la variación genética y la respuesta a los medicamentos. BMS también puede usar el ADN para estudiar las causas y progresión adicional del cáncer gástrico y otros tipos de cáncer. Para conseguir este objetivo pueden usarse conjuntamente muestras de este y otros estudios de investigación farmacogenética.
    Número de la enmienda 02- Subestudio Enmienda para biomarcadores de fecha 12 de enero de 2012
    Objetivo exploratorio 1: Identificar y/o confirmar biomarcadores de FD medidos en muestras de sangre que establecen la actividad biológica de ipilimumab utilizado secuencialmente tras la quimioterapia de primera línea para pacientes con cáncer gástrico.
    Objetivo exploratorio 2: Identificar y/o confirmar el valor pronóstico o predictivo de los biomarcadores de eficacia y seguridad medidos en las muestras de sangre basales obtenidas de pacientes con cáncer gástrico que reciben ipilimumab

    La toma de muestras se completará para todos los sujetos incluidos en los sitios que permiten a los estudios de biomarcadores descritos en este documento.
    E.3Principal inclusion criteria
    ? Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
    ? Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
    ? ECOG performance status of 0 or 1
    ? Measurable disease by modified WHO criteria (unless complete response for previous chemotherapy)
    a)Adenocarcinoma gástrico o de la unión gastroesofágica irresecable localmente avanzado o metastásico, confirmado histológicamente.
    b)Deben haber recibido quimioterapia de pre-inclusión en el contexto de primera línea usando uno de los regímenes de combinación con fluoropirimidina y platino especificados en el protocolo.
    c)Estado funcional de 0 a 1 del Eastern Cooperative Oncology Group (ECOG) a la entrada en el estudio
    d)Deben tener al menos una lesión medible (excepto los pacientes que tuvieron RC, por los criterios OMSm después de la última dosis de la quimioterapia de pre-inclusión). Esta lesión medible no debe haberse irradiado previamente.
    E.4Principal exclusion criteria
    ?Known HER2 positive status
    ?Radiological evidence of brain metastases
    ?History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
    ?Inadequate hematologic, renal and hepatic function
    a)Estado de positividad conocida de HER2
    b)Pruebas radiológicas de metástasis cerebrales
    c)Antecedentes documentados de enfermedad sintomática grave autoinmunitaria o mediada por el sistema inmunitario que precisó tratamiento inmunosupresor
    d)Función hematológica rnal y hepatica insuficiente,
    E.5 End points
    E.5.1Primary end point(s)
    Immune-related progression free survival (irPFS) as per assessment of a blinded Independent Review Committee (IRC) according to immune related response criteria (irRC) guidelines.
    supervivencia libre de progresión relacionada con el sistema inmunitario (SLPri) según la evaluación de un Comité de Revisión Independiente (IRC), desconocedor del tratamiento y de acuerdo con las directrices de los criterios de respuesta relacionados con el sistema inmunitario (CRri).
    E.5.1.1Timepoint(s) of evaluation of this end point
    91 irPFS events
    91 eventos de supervivencia libre de progresión relacionada con el sistema inmunitario
    E.5.2Secondary end point(s)
    ? progression free survival (PFS) per modified WHO criteria,
    ? Overall survival (OS),
    ? immune-related best overall response rate (irBORR),
    -Supervivencia libre de progresion segun criterios de la OMS modificados
    - La supervivencia global
    - Ratio de mejor respuesta global relacionada con el sistema inmunitario
    E.5.2.1Timepoint(s) of evaluation of this end point
    91 irPFS events
    91 eventos de supervivencia libre de progresión relacionada con el sistema inmunitario
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker Assessments (Absolute Lymphocyte Count); Outcomes Research Assessments (QoL instruments:EORTC QLQ-C30, EORTC STO-22 and EQ-5D)
    Evaluacion de biomarcadores (recuento absoluto de linfocitos) Análisis de investigación de resultados ( Instrumentos para la evaluación de la calidad de vida: cuestionario QLQ-C30 del EORTC, STO-22 y EQ-5D)
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Hong Kong
    Italy
    Korea, Republic of
    Russian Federation
    Singapore
    Spain
    Taiwan
    United States
    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
    Last visit of the last subject
    Ultima visita del último paciente
    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 months9
    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 months9
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 70
    F.4.2.2In the whole clinical trial 152
    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)
    At study end, subjects who continue to demonstrate clinical benefit will be eligible to receive ipilimumab via study extension, rollover study, or another mechanism at sponsor?s discretion. Sponsor may terminate access to study drug if any of the following occur: marketing application rejected by health authority; study terminated due to safety concerns; subject can obtain medication from a government sponsored/private health program; or therapeutic alternatives become available in local market.
    findeest,lossujquesigandemosbenefclíniseránelegipararecibirelfármdelestipi.fármdelestusefacilitarám ed una exte del estu,estde contque precisalaaprobporparte de las autorisaniyelcomitéticoatravedo mec a criterio del prom. prom sereservelderech dedarpor final elaccesoal farmdelestsiseproduc:solifarmelest siseproduce:solicidecomercesrechazporlasautorisanitresponsedaporfinealestproblsegurid;el sujpuede obte lamedicadeunprograpromovporelestadoounprogradesaludpriv.aparecealternaterapé er.lo
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-04-02
    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-Tue May 07 10:45:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA