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    Summary
    EudraCT Number:2005-001169-32
    Sponsor's Protocol Code Number:CA180-035
    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 number2005-001169-32
    A.3Full title of the trial
    A randomized two-arm, multicenter, open-label phase III study of BMS-354825 administered orally at a dose of 70 mg twice daily or 140 mg once daily in subjects with chronic myeloid leukemia in accelerated phase or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec). Revised protocol 06, incorporating administrative letters 01, 02, and 03 and amendments 01, 02, 03, 04 (v1.0 dated 28 Feb 2008) and 05 (v1.0 dated 19 Dec 2008).
    Studio clinico di fase II multicentrico, randomizzato, 2 bracci di trattamento, in aperto di BMS-354825 somministrato oralmente alla dose di 70 mg 2 volte al giorno o alla dose di 140 mg 1 volta al giorno, in pazienti con leucemia mieloide cronica in fase accelerata o blastica mieloide o blastica linfoide o leucemia acuta linfoblastica cromosoma Philadelphia positiva, che risultano resistenti o intolleranti a imatinib mesilato (Gleevec). Versione aggiornata n° 6 che incorpora le administrative letters 01, 02, 03 e gli emendamenti 01, 02, 03, 04 ( datati 28 febbraio 2008) e 05 (datato 19 Dicembre 2008).
    A.4.1Sponsor's protocol code numberCA180-035
    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-M.SQUIBB
    B.1.3.4CountryItaly
    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 namedasatinib
    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 INNdasatinib
    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 namedasatinib
    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 INNdasatinib
    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 myeloid leukemia in accelerated phase or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate.
    Pazienti con leucemia mieloide cronica in fase accelerata o blastica mieloide o blastica linfoide o leucemia acuta linfoblastica cromosoma Philadelphia 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 HLGT
    E.1.2Classification code 10024324
    E.1.2Term Leukaemias
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of BMS-354825 when administered to subjects at 140 mg QD relative to BMS-354825 administered at 70 mg BID. The QD schedule will be considered similar (non-inferior) to the BID schedule if the lower bound of the 2-sided 95% CI (equivalently, 1-sided 97.5% CI) of the difference (MHRQD - MHRBID) is #8805; -12%.
    Confrontare la percentuale di risposta ematologica maggiore a BMS-354825 ottenuta con il braccio QD rispetto alla schedula di riferimento BID.
    E.2.2Secondary objectives of the trial
    The secondary efficacy endpoints include the rates of overall hematologic response (OHR) and cytogenetic response (CyR), the difference of MHR between arms, the difference of OHR between arms, time to, and duration of MHR, progression-free and overall survival
    Gli ob.sec.di eff comprendono:% di risp ematologica globale(OHR),% di risp citogenetica(CyR),differenza di MHR tra i 2 bracci di tratt,durata della risp ematologica maggiore,tempo necessario ad ottenere la risp ematologica 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 qualità della vita.Verrà inoltre valutato lo spettro delle mutazioni al basale e al momento dellaprogr della malattia.Tra gli ob.sec.verrà valutato costantemente il profilo di tossicità di BMS-354825.Tutti i paz che ricevono qls farmaco in studio saranno considerati valutabili per la tossicità.Eventi avversi e altri sintomi verranno classificati in base a NCI Common Terminology Criteria per gli Eventi Avversi(CTCAE)v3.0.Tutti i paz verranno seguiti fino al decesso.I paz parteciperanno inoltre alla raccolta di campioni che contribuiranno ad un modello più ampio di valut PK
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    E.4Principal exclusion criteria
    1. Donne in stato di gravidanza o allattanti 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 entro 72 ore dall'inizio del trattamento. 4. Pazienti per i quali sia possibile un immediato trapianto autologo o allogenico di cellule staminali. 5. Pazienti con coinvolgimento del sistema nervoso centrale (presenza di cellule leucemiche nel liquor). 6. Un severo e non controllato problema medico o una infezione attiva che potrebbe impedire al paziente di ricevere la terapia prevista dal protocollo. 7. Una non controllata o significativa patologia cardiovascolare (per dettagli vedi protocollo Sez. 5.2). 8. Demenza o stato mentale alterato che potrebbe proibire la comprensione del consenso informato. 9. Una storia clinica di significativa malattia emorragica non correlata alla leucemia mieloide cronica. (per dettagli vedi protocollo Sez. 5.2). 10. Un'altra neoplasia associata diversa dalla leucemia mieloide cronica. 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: a. Idrossiurea entro 2 giorni (tranne se WBC &gt; 50,000/mm3) b. Imatinib, Interferone, 6-mercaptopurina o citarabina entro 7 giorni. c. Qualsiasi altro farmaco investigazionale o antineoplastico entro 14 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. Pazienti che stanno assumendo farmaci che inibiscono irreversibilmente la funzione piastrinica o anticoagulanti. 15. Precedente terapia con BMS-354825. 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 possano 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)
    Valutare la percentuale di risposta ematologica completa a BMS-354825 per entrambe le schedule di trattamento (70 mg BID o 140 mg QD) in ciascuno dei seguenti gruppi: pazienti con CML in fase accelerata, CML in fase blastica mieloide, CML in fase blastica linfoide o Ph+ ALL che presentino resistenza primaria o acquisita a imatinib mesilato. Gli obiettivi secondari di efficacia comprendono: percentuale di risposta ematologica globale (OHR), percentuale di risposta citogenetica (CyR), differenza di CHR tra i 2 bracci di trattamento, differenza di OHR tra i 2 bracci di trattamento, durata della risposta ematologica completa e globale, tempo necessario ad ottenere la risposta ematologica completa e globale, 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. Verra` inoltre valutato lo spettro delle mutazioni al basale e al momento della progressione della malattia. 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`. Eventi avversi e altri sintomi verranno classificati in base a NCI Common Terminology Criteria per gli Eventi Avversi (CTCAE) versione 3.0. Tutti i pazienti verranno seguiti fino al decesso. I pazienti parteciperanno inoltre alla raccolta di campioni che contribuiranno ad un modello piu` ampio di valutazione farmacocinetica.
    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 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
    diversa somministrazione dello stesso farmaco - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 239
    F.4.2.2In the whole clinical trial 540
    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 Decision2005-07-08
    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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    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
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