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    Summary
    EudraCT Number:2005-001294-99
    Sponsor's Protocol Code Number:CA180-034
    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:2005-08-11
    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 number2005-001294-99
    A.3Full title of the trial
    A randomized two-by-two, multicenter, open-label phase III study of BMS-354825 administered orally at a dose of 50 mg or 70 mg twice daily or 100 mg or 140 mg once daily in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia who are resistant or intolerant to imatinib mesylate (Gleevec). Revised protocol 06 incorporating administrative letters 01, 02, 03, 04 and 05 and amendments 01, 02, 03, 04 and 05 (v1.0 dated 14 Sep 2010).
    Studio clinico di fase III multicentrico, randomizzato 2 per 2, in aperto di BMS-354825 somministrato oralmente alla dose di 50 mg o 70 mg 2 volte al giorno o alla dose di 100 mg o 140 mg 1 volta al giorno, in pazienti con leucemia mieloide cronica in fase cronica cromosoma Philadelphia positiva o BCR-ABL positiva, che risultano resistenti o intolleranti a imatinib mesilato (Gleevec). Versione aggiornata n° 6 che incorpora le administrative letters 01, 02, 03, 04 e 05 e gli emendamenti 01, 02, 03, 04 e 05 (v.1 datato 14 settembre 2010.)
    A.4.1Sponsor's protocol code numberCA180-034
    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 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 namedasatininb
    D.3.2Product code BMS-354825
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdasatininb
    D.3.9.2Current sponsor codeBMS-354825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 namedasatininb
    D.3.2Product code BMS-354825
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdasatininb
    D.3.9.2Current sponsor codeBMS-354825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia who are resistant or intolerant to imatinib mesylate.
    Pazienti con leucemia mieloide cronica in fase cronica cromosoma Philadelphia positiva o BCR-ABL positiva, che risultano resistenti o intolleranti a imatinib mesilato.
    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 HLT
    E.1.2Classification code 10024296
    E.1.2Term Leukaemias chronic myeloid
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Confrontare l`attivita` di BMS-354825, definita come risposta citogenetica maggiore (MCyR), somministrato oralmente 1 volta al giorno, con l`attivita` di BMS-354825 somministrato oralmente 2 volte al giorno, nel trattamento di pazienti con CML in fase cronica resistenti ad imatinib. La schedula di trattamento QD sara` considerata efficace se verra` dimostrato che la percentuale vera di MCyR non e` piu` del 15% inferiore di quella ottenuta con la schedula BID.
    E.2.2Secondary objectives of the trial
    Valut la diff nelle % di MCyR tra i 2 livelli di TDD nel gruppo di paz resistenti ad imatinib.Gli ob.sec.di eff comprendono:% di risp ematologica completa(CHR),durata della risp ematologica completa e citogenetica maggiore,T nec ad ottenere la risp ematologica completa e citogenetica maggiore,sopravvivenza libera daprogr di malattia e sopravvivenza globale.I criteri per definire le risp e laprogr sono riportati nella sezione 3.3 del prot.Verrà anche effettuata la valut della QoL e verranno raccolti campioni che contribuiranno ad un modello più ampio di valut PK.Verrà inoltre valutato lo spettro delle mutazioni BCR-ABL e il livello di espressione del gene BCR-ABL.Tra gli ob.sec.verrà valutato costantemente il profilo di tossicità di BMS-354825.Tutti i paz che ricevono qls farm in studio saranno considerati valutabili per la tossicità e la toll al farm in studio.EA e altri sintomi verranno classificati in base a NCI Common Terminology Criteria per gli Eventi Avversi v3.0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    E.4Principal exclusion criteria
    1) Donne in stato di gravidanza o che allattano al seno. 2) Donne che non vogliono o siano incapaci di impiegare un metodo anticoncezionale accettato per tutto il periodo dello studio e per almeno un mese prima e tre mesi dopo il completamento dello studio stesso 3) Donne con un test di gravidanza positivo all`arruolamento o prima dell`inizio del trattamento. 4) Pazienti per i quali sia possibile un immediato trapianto autologo o allogenico di cellule staminali. 5) Un severo e non controllato problema medico o una infezione attiva che potrebbe impedire al paziente di ricevere la terapia prevista dal protocollo. 6) Una non controllata o significativa patologia cardiovascolare (per dettagli vedi protocollo Sez. 5.2) 7) Una storia clinica di significativa malattia emorragica non correlata alla leucemia mieloide cronica. 8) Una malattia emorragica clinicamente significativa del tratto gastrointestinale entro 6 mesi 9) Un`altra neoplasia associata diversa dalla leucemia mieloide cronica. 10) Demenza o stato mentale alterato che potrebbe proibire la comprensione del consenso informato 11) Evidenza clinica di una disfunzione d`organo o di compromessa funzionalita` digestiva che potrebbe impedire la somministrazione del farmaco in studio. 12) Pazienti che hanno ricevuto uno dei seguenti trattamenti: `Imatinib entro 7 giorni. `Interferone o citosina arabinoside entro 7 giorni. `Un agente anti-tumorale diretto verso target molecolari entro 7 giorni. `Qualsiasi altro farmaco investigazionale o antineoplastico diverso dall`idrossiurea entro 28 giorni. 13) Pazienti che stanno assumendo farmaci che sono generalmente accettati per poter causare potenzialmente una torsione di punta (per dettagli vedi protocollo sez 5.2). 14) I pazienti che hanno discontinuato il trattamento con uno di questi farmaci devono trascorrere un periodo di wash-out di almeno 5 giorni o almeno 5 emi-vite del farmaco (qualunque sia maggiore) prima di assumere la prima dose di farmaco in studio. 15) Pazienti che stanno assumendo farmaci che inibiscono irreversibilmente la funzione piastrinica o anticoagulanti. I criteri di eleggibilita` di questo studio sono stati accuratamente considerati per assicurare la sicurezza dei pazienti in studio e per assicurare che i risultati dello studio possa essere utilizzati. E` imperativo che i pazienti inclusi nello studio rispettino completamente tutti i criteri di eleggibilita`.
    E.5 End points
    E.5.1Primary end point(s)
    Confrontare l`attivita` di BMS-354825, definita come risposta citogenetica maggiore (MCyR), somministrato oralmente 1 volta al giorno, con l`attivita` di BMS-354825 somministrato oralmente 2 volte al giorno, nel trattamento di pazienti con CML in fase cronica resistenti ad imatinib. La schedula di trattamento QD sara` considerata efficace se verra` dimostrato che la percentuale vera di MCyR non e` piu` del 15% inferiore di quella ottenuta con la schedula BID. Valutare la differenza nelle percentuali di MCyR tra i due livelli di dose giornaliera totale (TDD) nel gruppo di pazienti resistenti ad imatinib. Gli obiettivi secondari di efficacia comprendono: percentuale di risposta ematologica completa (CHR), durata della risposta ematologica completa e citogenetica maggiore, tempo necessario ad ottenere la risposta ematologica completa e citogenetica maggiore, sopravvivenza libera da progressione di malattia e sopravvivenza globale. I criteri per definire le risposte e la progressione sono riportati nella sezione 3.3 del protocollo. Verra` anche effettuata la valutazione della qualita` della vita e verranno raccolti campioni che contribuiranno ad un modello piu` ampio di valutazione farmacocinetica. Verra` inoltre valutato lo spettro delle mutazioni BCR-ABL e il livello di espressione del gene BCR-ABL. Tra gli obiettivi secondari verra` valutato costantemente il profilo di tossicita` di BMS-354825. Tutti i pazienti che ricevono qualsiasi farmaco in studio saranno considerati valutabili per la tossicita` e la tollerabilita` al farmaco in studio. Eventi avversi e altri sintomi verranno classificati in base a NCI Common Terminology Criteria per gli Eventi Avversi (CTCAE) versione 3.0.
    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 No
    E.6.11Pharmacogenomic No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    two-by-two factorial design
    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
    QD vs BID - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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.1.1Number 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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 400
    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 Decision2005-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
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