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    Summary
    EudraCT Number:2009-016217-23
    Sponsor's Protocol Code Number:CA184-095
    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:2010-08-09
    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 number2009-016217-23
    A.3Full title of the trial
    Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
    Estudio fase III, aleatorizado, doble ciego para comparar la eficacia de Ipilimumab vs Placebo en pacientes metastásicos asintomáticos o mínimamente sintomáticos con cáncer de próstata resistente a la castración que no hayan recibido tratamiento quimioterápico previo.
    A.4.1Sponsor's protocol code numberCA184-095
    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 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 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 nameIpilimumab
    D.3.2Product code BMS-734016 / MDX010
    D.3.4Pharmaceutical form Intravenous 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 INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameMDX010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant protein
    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 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 Intravenous 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 INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameMDX010
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant protein
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Castration Resistant Prostate Cancer
    Cancer de Prostata resistente a la castración
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia global de sujetos con CPRC sin quimioterapia previa que hayan sido aleatorizados a ipilimumab frente a placebo.
    E.2.2Secondary objectives of the trial
    Comparar la supervivencia libre de progresión (SLP)
    Comparar el tiempo hasta la progresión del dolor
    Comparar el tiempo hasta el siguiente tratamiento sistémico no hormonal
    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 - Site Specific (version 3.0 dated 11-Jan-10)
    Enmienda Nº 01 de farmacogenética para Muestras de Sangre (version 3.0 fecha 11-Ene-10)
    E.3Principal inclusion criteria
    1)Firma del consentimiento informado por escrito
    2)Población diana
    a)Confirmación histológica o citológica de adenocarcinoma de próstata;
    b)Se hayan tratado mediante orquidectomía o estén recibiendo un análogo de LH-RH y tengan un nivel de testosterona </ = 50 ng/dl;
    c)Enfermedad metastásico por cualquiera de las siguientes modalidades: TC, RM, gammagrafía ósea;
    d)Progresión durante el tratamiento hormonal. A efectos de elegibilidad, la enfermedad progresiva se define como:
    i)Valores de PSA crecientes a intervalos de un mínimo de 1 semana y un valor inicial mínimo de 2,0 ng/ml (definido por el Prostate Cancer Working Group 2 [PCWG2])27 O;
    ii)Progresión en gammagrafía ósea: aparición de 2 o más lesiones nuevas, O;
    iii)Progresión según lesiones diana/enfermedad medible: progresión de la enfermedad ganglionar, según los criterios RECIST modificados 1.0. Sólo se considerarán los ganglios linfáticos mayores de 2 cm para evaluar un cambio en el tamaño que cualifique como progresión de la enfermedad.
    e)Deben suspenderse los antiandrógenos (bicalutamida, flutamida, nilutamida) o inhibidores de la producción de andrógenos suprarrenales (aminoglutetimida o ketoconazol) antes de comenzar el tratamiento del estudio:
    i)En sujetos con antecedentes de respuesta a un antiandrógeno o un inhibidor de la producción suprarrenal de andrógenos y progresión posterior mientras se recibe ese antiandrógeno, debe valorarse la respuesta a la retirada del antiandrógeno durante 4 semanas y se debe demostrar progresión sin antiandrógeno antes del reclutamiento;
    ii)En sujetos que nunca han respondido a los antiandrógenos, no es necesaria la observación de la respuesta a la retirada de los antiandrógenos; sin embargo, se necesita un período de lavado de 2 semanas antes del comienzo del tratamiento del estudio
    f)Estado funcional del ECOG 0-1;
    g)Asintomáticos o mínimamente asintomáticos.
    i)La enfermedad mínimamente sintomática se definirá como lo siguiente:
    (1)Si existe dolor relacionado con el cáncer, el dolor debe ser calificado por el paciente como </ = 4 de acuerdo con el punto n.º 3 del BPI-SF (“[en una escala de 0 a 10]... describa la intensidad máxima de dolor sentido en las últimas 24 horas.”) en todos los días durante el período de evaluación de 5 días antes de la aleatorización;
    (2)Cualquier dolor relacionado con el cáncer no debe precisar ningún analgésico opiáceo (incluidos la codeína y el dextropropoxifeno) durante el período de evaluación de 5 días antes de la aleatorización.
    3)Edad y sexo
    a)Varones >/ = 18 años o edad mínima de consentimiento según las normas locales.
    E.4Principal exclusion criteria
    1)Sexo y estado reproductivo
    a)Varones fértiles sexualmente activos que no usen métodos anticonceptivos eficaces si sus parejas son mujeres con capacidad fértil.
    2)Enfermedad diana
    a)No se permiten las metástasis viscerales (hígado, pulmón o cerebro);
    3)Historia médica y enfermedades concomitantes
    a)Enfermedad autoinmunitaria: se excluyen del estudio los sujetos con una historia documentada de enfermedad inflamatoria intestinal, incluida la colitis ulcerosa y la enfermedad de Crohn. Se excluye del estudio a los sujetos con antecedentes de enfermedad sintomática (p. ej., artritis reumatoide, tiroiditis autoinmunitaria (p. ej., enfermedad de Hashimoto), hepatitis autoinmunitaria, esclerosis sistémica progresiva (esclerodermia), lupus eritematoso sistémico, vasculitis autoinmunitaria (p. ej., granulomatosis de Wegener); se excluye de este estudio a los sujetos con neuropatía motora considerada de origen autoinmunitario (p. ej., síndrome de Guillain-Barré). Los pacientes con vitiligo son elegibles para entrar en el estudio.
    b)Menos de 1 año desde la resolución de una toxicidad de grado >/= 2 relacionada con el tratamiento dirigido al área pélvica (p. ej., enteritis por radiación);
    c)Demencia, alteración del estado mental o cualquier problema psiquiátrico que impediría la comprensión o la otorgación del consentimiento informado o la cumplimentación de los cuestionarios;
    d)Un trastorno médico grave no controlado que, en opinión del investigador, limitaría la capacidad del sujeto para recibir el tratamiento del protocolo;
    e)Tumor maligno previo activo dentro de los 3 años anteriores, excepto cánceres curables localmente que se han curado aparentemente y no necesitan tratamiento posterior, como cáncer cutáneo basal o epidermoide, cáncer de vejiga superficial o carcinoma in situ de la mama;
    f)Infección conocida por VIH o hepatitis B o hepatitis C.
    4)Hallazgos físicos y de las pruebas de laboratorio
    a)Función hematológica inadecuada, definida por un recuento absoluto de neutrófilos (ANC) < 1.500/mm3, un recuento de plaquetas < 100.000/mm3 o un nivel de hemoglobina < 9 g/dl;
    b)Función hepática inadecuada, definida por un nivel de bilirrubina total >/= 2,5 veces el límite superior de la normalidad (LSN), niveles de AST y ALT >/= 2,5 veces el LSN o >/= 5 veces el LSN si hay metástasis hepáticas;
    c)Función renal insuficiente, definida por un nivel de creatinina sérica >/= 2,5 veces el LSN;
    d)Aclaramiento de creatinina insuficiente, definido como menor de 50 ml/min;
    5)Tratamientos o terapias prohibidos
    a)Tratamiento previo con cualquier inmunoterapia para el cáncer de próstata, incluida la vacuna autóloga del cáncer de próstata sipuleucel-T (Provenge ®)
    b)Terapia citotóxica previa o continuada para el cáncer de próstata metastásico (p. ej., docetaxel, mitoxantrona, estramustina);
    c)Radioterapia dirigida a la pelvis en el plazo de 3 meses antes del comienzo del tratamiento del estudio;
    d)Uso crónico de inmunosupresores y/o corticosteroides sistémicos (empleados en el tratamiento del cáncer o enfermedades no relacionadas con el cáncer). Sin embargo, durante el transcurso del estudio, se permite el uso de corticosteroides si se usan para tratar los AAri o las insuficiencias suprarrenales;
    e)Cualquier tratamiento con vacuna no oncológica empleada para la prevención de enfermedades infecciosas (hasta 4 semanas antes de o después de cualquier dosis del fármaco del estudio a doble ciego);
    f)Tratamiento previo con cualquier inhibidor o agonista de la coestimulación de los linfocitos T;
    g)Tratamiento previo con radioisótopos (p. ej., estroncio-89, samario-153 o agentes similares);
    6)Otros criterios de exclusión
    a)Prisioneros o detenidos por la fuerza (encarcelados involuntariamente).
    b)Sujetos detenidos por la fuerza para el tratamiento de una enfermedad psiquiátrica o física (p. ej., una enfermedad infecciosa).
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de supervivencia global (SG) se definirá como el tiempo desde la fecha de la aleatorización hasta la fecha de la muerte. En los sujetos que no hayan fallecido, la SG se censurará en la última fecha en la que se sepa que el sujeto está vivo.
    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 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
    Immunogenicity (HAHA); Outcomes Research Assessments
    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 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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    For all subjects, contact will be made every 12 weeks to evaluate Overall Survival (OS) and collect data on the initiation of subsequent therapy for prostate cancer.

    The final analysis of OS will be performed when 379 events (deaths) have been observed. This is expected to occur ~52 months after the first subject has been randomized. Additional survival follow-up may occur after the final OS analysis to further characterize long-term survival for subjects randomized in this study.
    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 months5
    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 months5
    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 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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 217
    F.4.2.2In the whole clinical trial 725
    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)
    Los sujetos que completen el estudio y demuestren beneficio clínico, serán elegibles para recibir el fármaco de estudio que se proporcionará con un estudio de extensión aprobado por CEIC/AEMPS, estudio rollover u otro método a discreción del promotor, que se reserva el derecho a finalizar el acceso si:
    -la aprobación de comercialización es rechazada por las Autoridades Sanitarias
    -el estudio finaliza por seguridad
    -se puede obtener el fármaco del Gobierno/ Sanidad Privada; O
    - alternativa
    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 Decision2010-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-07-17
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