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    Summary
    EudraCT Number:2012-000075-16
    Sponsor's Protocol Code Number:BAY88-8223/16216
    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: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 number2012-000075-16
    A.3Full title of the trial
    Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
    Cloruro de radio-223 (Alpharadin) en pacientes con cáncer de próstata resistente a la castración (hormonorresistente) con metástasis ósea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radium-223 Chloride in the treatment patients diagnosed with prostate cancer that has spread to the bone
    Cloruro de radio-223 en el tratamiento de pacientes con diagnóstico de cáncer de próstata que se ha extendido a los huesos
    A.4.1Sponsor's protocol code numberBAY88-8223/16216
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref:"EU CTR"/ Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameRadium-223 chloride
    D.3.2Product code BAY88-8223
    D.3.4Pharmaceutical form Solution for injection
    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 INNRadium-223 chloride
    D.3.9.1CAS number 444811-40-9
    D.3.9.2Current sponsor codeBAY88-8223
    D.3.10 Strength
    D.3.10.1Concentration unit kBq/ml kilobecquerel(s)/millilitre
    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) 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 Yes
    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 No
    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
    Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis
    Pacientes con cáncer de próstata resistente a la castración (hormonorresistente) con metástasis ósea
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which has spread to the bone
    Cáncer de próstata con diseminación ósea
    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 LLT
    E.1.2Classification code 10036916
    E.1.2Term Prostate cancer stage D
    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
    Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis

    To assess acute and long-term safety of radium-223 chloride
    Administrar cloruro de radio-223 a pacientes a los que se les ha diagnosticado un cáncer de próstata resistente a la castración / hormonorresistente (CPRC/CPHR) con metástasis ósea

    Evaluar la seguridad a corto y largo plazo del Ra-223 Cl
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the any trial- specific procedure.
    ? Age ? 18 years
    ? Histologically or cytologically confirmed prostate cancer
    ? Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
    ? Progressive disease is defined either by:
    o The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR
    o In the absence of a new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ?5 ng/mL
    ? Life expectancy ? 6 months
    ? ECOG PS 0-2
    ? Adequate hematological, liver and renal function
    o Absolute neutrophil count (ANC) ? 1.5 x109/L
    o Platelet count ? 100 x109/L
    o Hemoglobin ?10.0 g/dL (100 g/L; 6.2 mmol/L)
    o Total bilirubin level ? 1.5 x institutional upper limit of normal (ULN)
    o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN
    o Creatinine ? 1.5 x ULN
    o Albumin > 25 g/L
    ? Willing and able to comply with the protocol, including follow-up visits and examinations
    ? Ha entregado su consentimiento informado por escrito. Los sujetos deben entender y estar dispuestos a firmar el formulario de consentimiento informado (FCI). Antes de llevar a cabo cualquier procedimiento específico del ensayo se ha de obtener un FCI escrito.
    ? Edad > = 18 años
    ? Cáncer de próstata confirmado histológica o citológicamente
    ? Pacientes diagnosticados de CPRC/CPHR progresivo con metástasis predominantemente óseas con un mínimo de 2 metástasis óseas detectadas en escáner sin metástasis pulmonar, hepática y/o cerebral ( en los ganglios linfáticos solo se permiten metástasis)
    ? La enfermedad progresiva se define por:
    o La aparición de nuevas lesiones óseas. Si la progresión solo se basa en la detección de lesiones nuevas mediante escáner, sin incremento del antígeno prostático específico (PSA), deben proporcionarse los valores del PSA de 3 análisis realizados en los últimos 6 meses; O
    o En ausencia de lesiones óseas nuevas, mediante 2 elevaciones consecutivas del PSA sérico respecto al valor de referencia anterior, que deben haberse obtenido como máximo 6 meses antes de la selección, cada una de ellas medida con una diferencia de al menos 1 semana con el último valor de PSA ? 5 ng/ml
    ? Esperanza de vida >= 6 meses
    ? Estado funcional (EF) del Grupo oncológico cooperativo del este (ECOG) 0-2
    ? Función hematológica, hepática y renal normal
    o Recuento absoluto de neutrófilos (ANC) >= 1,5 x109/L
    o Recuento de plaquetas >= 100 x109/L
    o Hemoglobina >=10,0 g/Ll (100 g/L; 6,2 mmol/L)
    o Nivel total de bilirrubina <= 1,5 x límite superior de la normalidad (LSN) institucional
    o Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) <= 2,5 x LSN
    o Creatinina <= 1,5 x LSN
    o Albúmina > 25 g/L
    ? Con voluntad y capacidad para cumplir el protocolo, incluidas las exploraciones y las visitas de seguimiento
    E.4Principal exclusion criteria
    ? Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
    ? Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
    ? Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
    ? Received previous radiotherapy to approximately > 25% of bone marrow, including hemibody radiation
    ? Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases
    ? Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
    ? Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality
    ? Presence of brain metastases
    ? Lymphadenopathy exceeding 6 cm in short-axis diameter
    ? Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
    ? Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
    ? Any other serious illness or medical condition, such as but not limited to:
    o Any infection ? NCI-CTCAE v.4.03 Grade 2
    o Cardiac failure New York Heart Association (NYHA) III or IV
    o Crohn?s disease or ulcerative colitis
    o Bone marrow dysplasia
    ? Fecal incontinence
    ? Tratamiento con un medicamento experimental en las 4 semanas anteriores o planificado durante el período de tratamiento o de seguimiento
    ? Elegible para el primer ciclo de docetaxel, es decir, pacientes en buena forma física, que deseen recibir tratamiento con docetaxel y residan en un lugar en el que el tratamiento con docetaxel esté disponible
    ? Tratamiento con quimioterapia antineoplásica en las 4 semanas anteriores, o ausencia de recuperación de AA sufridos debido a la quimioterapia antineoplásica administrada más de 4 semanas antes (no obstante, se permite neuropatía en curso)
    ? Administración previa de radioterapia en > 25% de la médula ósea, incluida radiación hemicorporal
    ? Administración de terapia sistémica con radionucleidos (ej. estroncio-89, samario-153, renio-186 o renio-188, o cloruro de radio-223) para el tratamiento de metástasis óseas
    ? Otras neoplasias malignas tratadas en los últimos 3 años (excepto cáncer de piel no melanoma o tumor vesical superficial de bajo grado)
    ? Metástasis viscerales detectadas mediante tomografía axial computarizada (TAC) pélvica o abdominal (u otra modalidad de diagnóstico por imagen)
    ? Presencia de metástasis cerebrales
    ? Linfadenopatía con diámetro del eje corto superior a 6 cm
    ? Linfadenopatía pélvica de cualquier tamaño si se cree que contribuye a hidronefrosis concomitante.
    ? Compresión inminente o previa de la médula espinal en base a los hallazgos clínicos y/o resonancia magnética (RM)
    ? Cualquier otra enfermedad o afección médica grave, como, entre otras:
    o Cualquier infección superior o igual a grado 2 según los criterios terminológicos comunes para acontecimientos adversos (CTCAE) del Instituto Nacional del Cáncer (INC), Versión 4.03
    o Insuficiencia cardiaca de clase III o IV según la definición de la New York Heart Association (NYHA)
    o Enfermedad de Crohn o colitis ulcerosa
    o Displasia medular
    ? Incontinencia fecal
    E.5 End points
    E.5.1Primary end point(s)
    Acute (during treatment and up to 30 days last treatment) and Long-Term Safety (30 days last treatment and on-ward)
    Evaluaciones de la seguridad a CORTO PLAZO (medidas durante el período de tratamiento y hasta el día 30 después del tratamiento) y a LARGO PLAZO (medidas a partir del día 30 después del tratamiento y durante el período de seguimiento).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment and follow-up

    Upon obtaining signed informed consent, obtain baseline safety data.

    During the treatment period, patients will be evaluated
    at each visit, prior to receiving Ra-223 Cl.
    During the follow-up period, patients will be evaluated every 6 months for long-term safety.
    Durante el período de tratamiento y durante el período de seguimiento.

    Tras obtener el consentimiento informado firmado, se obtendran los datos de seguridad basales.

    Durante el período de tratamiento, se evaluará a los pacientes en cada visita, antes de la administración de Ra-223 Cl.
    Durante el período de seguimiento, los pacientes serán evaluados cada 6 meses para controlar la seguridad a largo plazo.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    Quality of Life will be evaluated by BPI-SF (this is not primary outcome/variable)
    La calidad de vida se medirá con el cuestionario validado BPID-SF (esta no es una variable primaria)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Slovakia
    Spain
    Sweden
    Switzerland
    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
    For each participating European Union (EU) country, the end of the study according to the EU Clinical Trial Directive will be reached when the last visit of the last patient for all centers in the respective country has occurred.

    Sites/Countries will be closed to enrolment as marketing approval of radium-223 chloride is obtained for that country.
    En cada país participante de la Unión Europea (UE), el final del estudio con arreglo a la Directiva de ensayos clínicos de la UE se alcanzará cuando se produzca la última visita al último paciente en todos los centros del país respectivo.

    Cuando las autoridades sanitarias autoricen la comercialización de Ra-223 Cl y éste se ponga a la venta. Esta finalización tendrá lugar según los países.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 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: 925
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1875
    F.4.2.2In the whole clinical trial 1925
    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)
    Not applicable.
    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 Decision2012-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-28
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