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    Summary
    EudraCT Number:2012-000075-16
    Sponsor's Protocol Code Number:BAY88-8223/16216
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedItaly - Italian Medicines Agency
    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 di radio-223 (Alpharadin) nei pazienti affetti da tumore alla prostata resistente alla castrazione (ormonerefrattario) con metastasi ossee
    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 di radio-223 nel trattamento di pazienti con diagnosi di cancro alla prostata che si � diffuso alle ossa
    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 Clin Trials, Contact CTP Team
    B.5.3 Address:
    B.5.3.1Street AddressBayer Pharma AG, S102, Level 2, Rm 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number.
    B.5.5Fax number.
    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
    Tumore alla prostata resistente alla castrazione (ormonerefrattario) con metastasi ossee
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which has spread to the bone
    Tumore alla prostata che si è diffuso alle ossa
    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
    - Somministrare il cloruro di radio-223 (Ra-223 Cl) ai pazienti con diagnosi di tumore alla prostata resistente alla castrazione/ormone refrattario (CRPC/HRPC) con metastasi ossee - Valutare la sicurezza a lungo termine e in fase acuta di Ra-223 Cl
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    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: - 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 - 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
    • Devono aver fornito un consenso informato scritto. I pazienti devono essere in grado di comprendere un consenso informato scritto (CI) e decidere se firmarlo o meno. Prima di condurre qualsiasi procedura sperimentale specifica si deve ottenere un ICF firmato nelle modalità appropriate. • Età ≥ 18 anni. • Tumore alla prostata confermato istologicamente o citologicamente. • Pazienti con diagnosi di CRPC/HRPC progressivo con metastasi ossea predominante con almeno 2 metastasi scheletriche dimostrate da scansione ossea, senza metastasi a polmoni, fegato e/o cervello (sono consentite solo metastasi ai linfonodi). • Una malattia progressiva è definita dalle seguenti condizioni: o La manifestazione di nuove lesioni ossee. Se la progressione si basa esclusivamente su una o più nuove lesioni osservabili alla scansione ossea senza un aumento del valore di antigene prostatico specifico (PSA), si devono fornire i valori di PSA delle ultime 3 valutazioni eseguite negli ultimi 6 mesi OPPURE o in assenza di nuove lesioni ossee, da 2 aumenti consecutivi del valore di PSA sierico rispetto al valore di riferimento precedente,che non deve essere stato rilevato da più di 6 mesi prima dello screening, ogni misurazione deve essere stata eseguita a una distanza di almeno una settimana dall'ultimo valore di PSA ≥5 ng/ml. • Aspettativa di vita ≥6 mesi. • Stato prestazione (PS) ECOG (Eastern Cooperative Oncology Group) 0-2. • Funzionalità ematologica, epatica e renale adeguata. o Conta assoluta dei neutrofili (ANC) ≥ 1,5 x109/l. o Conta delle piastrine ≥ 100 x109/l. o Emoglobina ≥10,0 g/dl (100 g/l; 6,2 mmol/l). o Bilirubina totale ≤ 1,5 volte il limite superiore normale (ULN) istituzionale. o Aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) ≤ 2,5 x ULN. o Creatinina ≤ 1,5 x ULN. o Albumina &gt; 25 g/l. • I pazienti devono volere ed essere in grado di attenersi a quanto specificato nel protocollo, anche per ciò che riguarda le visite di follow-up e gli esami.
    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 nonmelanoma 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
    Trattamento con un farmaco sperimentale nelle 4 settimane precedenti o pianificato per il periodo di trattamento o di follow-up. • Pazienti eleggibili per il primo corso di docetaxel, cioè quei pazienti che sono idonei, disponibili e vivono in un'area in cui è disponibile il trattamento con docetaxel. • Trattamento con chemioterapia citotossica nelle 4 settimane precedenti o che non guariscono da AE provocati dalla chemioterapia citotossica somministrata prima delle ultime 4 settimane (in ogni caso, è consentita la neuropatia in corso). • Radioterapia pregressa a &gt; 25% del midollo osseo, tra cui la radioterapia esterna di un emicorpo. • Terapia sistemica con radionuclidi (per es. stronzio 89, samario 153, renio 186, renio 188 o cloruro di radio-223 ) somministrata per il trattamento delle metastasi ossee. • Altre malattie maligne trattate negli ultimi 3 anni (esclusi il carcinoma cutaneo non-melanomatoso e il carcinoma superficiale della vescica di grado basso). • Metastasi viscerali dimostrate da tomografia computerizzata (TC) addominale o pelvica (o altre modalità di imaging). • Presenza di metastasi al cervello. • Linfoadenopatia con diametro dell'asse corto maggiore di 6 cm. • Linfoadenopatia pelvica di qualsiasi dimensione, se si ritiene che contribuisca all'idronefrosi concomitante. • Anamnesi di compressione del midollo spinale pregressa o attuale in base a riscontri clinici e/o esame di risonanza magnetica (RM). • Qualsiasi altra malattia o condizione medica grave, come per es.: o qualsiasi infezione ≥ grado 2 secondo i criteri comuni di terminologia per gli eventi avversi, versione 4.03 del National Cancer Institute (NCI-CTCAE); o scompenso cardiaco di grado III o IV secondo i criteri di classificazione NYHA (New York Heart Association); o malattia di Crohn o colite ulcerosa; o displasia midollare. • Incontinenza fecale.
    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 onward)
    Sicurezza in fase acuta (durante il periodo di trattamento e fino a 30 giorni dall'ultimo trattamento) e sicurezza a lungo termine (dai 30 giorni successivi dopo l'ultimo trattamento in avanti)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment and follow-up
    Durante il periodo di trattamento e di follow up
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    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
    Dopo l'ottenimento del consenso informato, alla visita basale saranno rilevate informazione di sicurezza. Durante il periodo di trattamento i pazienti saranno valutati a ogni visita, prima di ricevere Ra-223 Cl. Durante il periodo di follow-up i pazienti saranno valutati ogni 6 mesi per la sicurezza a lungo termine
    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 Yes
    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 qualità della vita sara valutata dal questionario BPI-SF (questa non è la variabile 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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned29
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA189
    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
    Canada
    Israel
    Switzerland
    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.
    LPLV. Nel momento in cui un Paese otterrà l'autorizzazione all'immissione in commercio per il cloruro di radio-223, l'arruolamento in quel paese (e nei relativi centri) verrà chiuso
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months22
    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.1.1Number of subjects for this age range: 0
    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 state261
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1700
    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
    Non applicabile
    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 Decision2012-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-28
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