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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

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    Summary
    EudraCT Number:2014-002987-34
    Sponsor's Protocol Code Number:CA184-437
    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:2014-11-18
    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 number2014-002987-34
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic

    Pharmacogenetics Blood Sample Amendment Number 01
    Estudio Fase 2 aleatorizado, doble ciego, de ipilimumab administrado a dosis de 3 mg/kg frente a 10 mg/kg en sujetos adultos con cáncer de próstata metastásico resistente a la castración asintomáticos o con mínima sintomatología y no tratados previamente con quimioterapia

    Enmienda sobre muestras de sangre para farmacogenética Número 1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naive
    Estudio de eficacia y seguridad de 3 mg/kg frente a 10 mg/kg en sujetos adultos con cáncer de próstata metastásico resistente a la castración no tratados previamente con quimioterapia
    A.4.1Sponsor's protocol code numberCA184-437
    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 pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    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
    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 nameBMS734016
    D.3.9.4EV Substance CodeSUB22577
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
    Cáncer de próstata metastásico resistente a la castración en pacientes no tratados previamente con quimioterapia
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    Cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses ( 3 mg/kg and 10 mg/kg) of ipilimumab (Yervoy?) in patients with metastatic castration resistant prostate cancer
    El propósito de este estudio es evaluar la seguridad y efectividad (cómo de bien trabajado el fármaco) de dos dosis distintas (3 mg/kg y 10 mg/kg) de ipilimumab (Yervoy?) en el tratamiento del cáncer de próstata metastásico resistente a la castración.
    .
    E.2.2Secondary objectives of the trial
    - To assess the rate of severe irAEs
    - To assess overall survival
    - To assess PSA PFS
    - To assess PSA response
    - To assess time to pain progression
    ? Evaluar la tasa de AAri graves
    ? Evaluar la supervivencia global
    ? Evaluar la SLP según PSA
    ? Evaluar la respuesta según PSA
    ? Evaluar el tiempo hasta la progresión del dolor.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Blood Sample Amendment number 01 09-Sep-2014.
    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, CA184437
    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 prostate cancer. Samples from
    this study may also be used in conjunction with pharmacogenetic research results from other
    clinical studies to accomplish this objective.
    Enmienda sobre muestras de sangre para farmacogenética Número 1, 9-Sept-2014.
    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, CA184437, para estudiar la asociación entre la variación genética y la respuesta a los medicamentos. Bristol-Myers Squibb también puede usar el ADN para estudiar las causas y progresión adicional del cáncer de próstata. Para conseguir este objetivo pueden usarse conjuntamente muestras de este y otros estudios de investigación farmacogenética.
    E.3Principal inclusion criteria
    - Prostate cancer with metastases
    - Prostate cancer should be castration resistant
    - Progression during hormonal therapy
    Please see protocol for further information on inclusion criteria
    - Cáncer de próstata con metástasis
    - El cáncer de próstata debe ser resistente a la castración
    - Progresión durante la terapia hormonal.
    Ver el protocolo para tener la información completa sobre los criterios de inclusión.
    E.4Principal exclusion criteria
    - Visceral metastases (eg liver, lung or brain metastases)
    - Prior treatment with any immunotherapy for prostate cancer
    - Prior or ongoing cytotoxic therapy for prostate cancer
    - Autoimmune disease
    - Inadequate hematologic, renal, or hepatic function
    Please see protocol for further information on exclusion criteria
    - Metástasis viscerales (p. ej., hepáticas, pulmonares o cerebrales)
    - Tratamiento previo con cualquier inmunoterapia para el cáncer de próstata
    - Terapia citotóxica previa o continuada para el cáncer de próstata metastásico
    - Enfermedad autoinmune
    - Función hematológica, renal o hepática inadecuada
    Ver el protocolo para tener la información completa sobre los criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Radiologic Progression Free Survival: Radiographic PFS (rPFS) is defined as the time from randomization to the earliest date on which either of the following events was documented: radiographic progression (per PCWG2 for bone lesions and modified RECIST 1.1 for non-bone lesions) or death. All radiological progression will be based on investigator assessments.
    Supervivencia libre de progresión radiográfica (SLPr): se define como como el tiempo desde la fecha de la aleatorización hasta la fecha más temprana en que se documente uno de los sieugientes eventos: progresión radiográfica (de acuerdo con los criterios adaptados del PCWG2 para lesiones óeas y del RECIST 1.1 para lesiones no-ósea) o muerte. La progresión radiológica se basará en las evaluaciones del investigador.

    de progresión de la enfermedad basada en pruebas radiográficas y/o la muerte por cualquier causa, lo que suceda antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 12 months
    aproximadamente 12 meses.
    E.5.2Secondary end point(s)
    Rate of severe immune-related adverse events, Overall survival, Prostate Specific Antigen Progression-free Survival, Prostate Specific Antigen Response Rate, Time to Pain Progression
    Tasa de Acontecimientos Adversos relacionados con inmunidad graves, supervivencia global, SLP según Antígeno Específico de Próstata, respuesta según Antígeno Específico de Próstata, tiempo hasta la progresión del dolor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 36 months
    aproximadamente 36 meses
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dosis distintas del mismo producto
    different dose of the same product
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Argentina
    Australia
    Chile
    Colombia
    France
    Germany
    Italy
    Mexico
    Netherlands
    Spain
    United Kingdom
    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
    The end of the study is defined as 3 years after the date when the last subject receives the first
    induction dose of ipilimumab or the date when the last subject dies, whichever occurs first
    El final del estudio se define como 3 años después de la fecha en la que el último sujeto recibe la primera dosis de inducción de ipilimumab o la fecha en la que fallezca el último sujeto, aquello que suceda antes.
    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 months9
    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 months10
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 250
    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 the end of the study duration, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Al final de la duración del estudio, BMS no seguirá proporcionando el fármaco del estudio facilitado por BMS a los sujetos/investigadores a menos que BMS decida ampliar el estudio. El investigador debe asegurarse de que el sujeto recibe un tratamiento de referencia adecuado para la enfermedad en estudio.
    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 Decision2015-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-15
    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.

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