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    Summary
    EudraCT Number:2011-006180-21
    Sponsor's Protocol Code Number:CA180-400
    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:2013-01-14
    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 number2011-006180-21
    A.3Full title of the trial
    A PHASE IV, OPEN-LABEL, MULTICENTER STUDY OF DASATINIB IN CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) PATIENTS WITH CHRONIC LOW-GRADE NONHEMATOLOGIC TOXICITY TO IMATINIB
    Studio di fase IV, in aperto, multicentrico sul dasatinib in pazienti affetti da Leucemia Mieloide Cronica in fase cronica (CP-LMC) in terapia con imatinib che presentano tossicitàcronica non ematologica di basso grado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    dasatinib in chronic phase chronic mieloid leukemia patients with chronic toxicity to imatinib
    Dasatinib in pazienti affetti da Leucemia Mieloide Cronica in fase cronica con tossicità cronica a imatinib
    A.3.2Name or abbreviated title of the trial where available
    Studio CA180-400
    A.4.1Sponsor's protocol code numberCA180-400
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Start Up Department
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 Yes
    D.2.1.1.1Trade name Sprycel
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 302962-49-8
    D.3.9.2Current sponsor codeBMS-354825
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 100
    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 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
    CP-CML patients with non hematologic low toxicity grade to imatinib
    Pazienti affetti da Leucemia Mieloide Cronica in fase cronica (CP-LMC) con tossicità non ematologica di basso grado a imatinib
    E.1.1.1Medical condition in easily understood language
    Patient affected by Chronic Phase Chronic Myeloid Leukemia under imatinib treatment who have mild toxic reactions not in the blood to imatinib
    Pazienti affetti da Leucemia Mieloide Cronica in fase cronica sotto trattamento con imatinib che mostrano reazioni di tossicità media all’imatinib non a livello del sangue
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the frequency of reduction in grade (Grade 2 to 1) or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs within 3 months after switch to dasatinib in patients with CP-CML.
    Obiettivo primario è la valutazione della frequenza della riduzione in gradi (dal Grado 2 al Grado 1) o la risoluzione degli EA non ematologici cronici di grado 1 o 2 correlati a imatinib entro 3 mesi dal passaggio a dasatinib in pazienti con LMC-FC.
    E.2.2Secondary objectives of the trial
    - Frequency of dasatinib-related AEs • Mean change in M.D. Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) symptom severity and interference score from baseline to 3, 6, and 12 months after switch to dasatinib • Mean change in EORTC-Quality of Life Questionnaire (EORTC-QLQ-C30) score from baseline to 6 and 12 months after switch to dasatinib • Proportion of patients with reduction in grade (Grade 2 to 1) or resolution of at least 1 imatinib-related chronic Grade 1 or Grade 2 non-hematologic adverse event within 3 months after switch to dasatinib, without an increase in grade of any imatinib-related, chronic, Grade 1 or 2, non-hematologic adverse event
    - Frequenza di EA correlati al dasatinib
    • Modifica primaria della severità dei sintomi della leucemia mieloide cronica attraverso la scala di valutazione dei Sintomi di MD Anderson e punteggio di interferenza dalla visita basale dopo 3, 6, 12 mesi dal passaggio al dasatinib.
    • Modifica primaria nel punteggio del Questionario sulla Qualità della vita EORTC (EORTC-QLQ-C30) dalla visita basale a 6, 12 mesi dopo il passaggio al dasatinib.
    • Percentuale di pazienti con riduzione in gradi (da Grado 2 a 1) o risoluzione di almeno 1 EA non ematologico cronico di grado 1 o 2 correlato a imatinib entro 3 mesi dal passaggio a dasatinib senza un incremento di grado di alcun EA non emetologico cronico di Grado 1 o 2 correlato a imatinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signed Informed - Subjects with CP-CML achieving an optimal response (either CHR by 3 months, PCyR by 6 months, or CCyR by 12 months) to imatinib ≤ 400 mg/day treatment - Currently experiencing at least one imatinib-related Grade 1 or 2 non-hematologic adverse event persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care Daily ECOG performance status = 0 – 2 - Life expectancy >6 months - Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN - Adequate hepatic function defined as: total bilirubin ≤ 3.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5.0 times the institutional upper limit of normal (ULN) - Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal. Subjects with low K, Mg levels, total serum Ca and/or ionized Ca must be repleted to allow for protocol entry. - Men and women, ages 18 or older - Women of childbearing potential (WOCBP) must use highly effective methods of birth control to minimize the risk of pregnancy. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of 1 month (4 weeks) after dosing has been completed. Acceptable methods of highly effective birth control include: • Condom with spermicide • Diaphragm and spermicide • Cervical cap and spermicide The use of intrauterine devices, (IUDs) shall be at the discretion of the investigator. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. - Women must not be breastfeeding - Sexually active fertile men must use highly effective birth control if their partners are WOCBP. Men that are sexually active with WOCBP must follow instructions for birth control for the entire duration of the study and a minimum of 1 month (4 weeks) after dosing has been completed.
    Consenso informato scritto firmato
    1) Popolazione target
    a) Soggetti con LMC-FC che raggiungano una risposta ottimale (REC entro 3 mesi, RCgP entro 6 mesi, o RCgC entro 12 mesi) con il trattamento a base di imatinib ≤ 400 mg/giorno
    b) Soggetti in cui attualmente si manifesti almeno un evento avverso non ematologico di grado 1 o 2 correlato a imatinib e persistente per almeno 2 mesi o ricorrente almeno 3 volte nei precedenti 12 mesi, nonostante la migliore terapia di supporto
    c) Stato di performance ECOG giornaliero = 0 - 2 (Appendice 2)
    d) Aspettativa di vita &gt; 6 mesi
    e) Funzionalità renale adeguata, definita come un livello di creatinina sierica ≤ 3 volte il limite superiore della norma (ULN) istituzionale
    f) Funzionalità epatica adeguata, definita come: bilirubina totale ≤ 3,0 volte l’ULN istituzionale; alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤ 5,0 volte il limite superiore del normale (ULN) istituzionale
    g) I livelli di Na, K, Mg nel siero e il Ca sierico totale o i livelli di Ca ionizzato devono essere maggiori o uguali al limite inferiore del normale istituzionale. I soggetti con bassi livelli di K, Mg, Ca sierico totale e/o Ca ionizzato devono essere sottoposti a replezione per consentirne l’inserimento nel protocollo.
    2) Età e maturazione sessuale
    a) Uomini e donne di età pari o superiore a 18 anni
    b) Le donne in età fertile devono utilizzare metodi contraccettivi altamente efficaci per ridurre il rischio di gravidanza. Le donne in età fertile devono seguire le istruzioni contraccettive per l’intera durata dello studio, incluso un minimo di 1 mese (4 settimane) dopo il completamento del dosaggio.
    I metodi di contraccezione altamente efficaci accettabili includono:
    • Preservativo con spermicida
    • Diaframma e spermicida
    • Cappuccio cervicale e spermicida

    L’utilizzo di dispositivi intrauterini (IUD) sarà consentito a discrezione dello sperimentatore.
    Le donne devono avere un risultato negativo al test di gravidanza sierologico o urinario (sensibilità minima 25 UI/l o equivalenti unità di HCG) nelle 72 ore prima dell’inizio del farmaco sperimentale.
    c) Le donne non devono allattare al seno
    d) Gli uomini fertili sessualmente attivi devono utilizzare un metodo contraccettivo altamente efficace se le loro partner sono in età fertile. Gli uomini sessualmente attivi con partner in età fertile devono seguire le istruzioni contraccettive per l’intera durata dello studio e per un minimo di 1 mese (4 settimane) dopo il completamento del dosaggio.
    E.4Principal exclusion criteria
    - Previous treatment with any other TKI, except imatinib - Current Grade 3 or 4 imatinib-related adverse event - Subjects with clonal evolution in Ph+ cells observed in ≥ 2 metaphases at baseline bone marrow (BM) cytogenetic test, unless the same abnormalities were present at diagnosis (See Section 5.8.2 for subjects exempt from baseline bone marrow cytogenetic assessment) - Subjects with previous loss of CHR or loss of major cytogenetic response (MCyR) on imatinib - Previous diagnosis of accelerated or blast phase CML - A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy - Uncontrolled or significant cardiovascular disease, including any of the following: i. Congestive cardiac failure (NYHA > 2) within 3 months ii. Diagnosed or suspected congenital long QT syndrome iii. Any history of clinically significant ventricular arrhythmias iv. Prolonged QTcF interval on pre-entry electrocardiogram (> 450 msec) v. Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker) vi. Uncontrolled angina within 3 months vii. Prior myocardial infarction within 6 months viii. Uncontrolled hypertension - Known pulmonary arterial hypertension - Pleural or pericardial effusions of any grade at study entry are excluded. Subjects previously diagnosed with pleural/pericardial effusion of any grade resolved at the time of study entry are allowed - History of significant bleeding disorder unrelated to CML, including i. Diagnosed congenital bleeding disorders (eg, von Willebrand’s disease) ii. Diagnosed acquired bleeding disorder within one year (eg, acquired antifactor VIII antibodies) - Serious mental illness interfering with the ability to participate in the study - Prior documented T315I mutation (Enrollment is not dependent upon results of baseline mutation analysis) - Patients who are pregnant or breastfeeding or likely to become pregnant - Men whose partner is unwilling or unable to avoid pregnancy - Prisoners or subjects who are involuntarily incarcerated - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. - Subjects unable to complete patient-reported outcomes without assistance
    1) Eccezioni alla malattia target
    a) Precedente trattamento con qualsiasi altro TKI, eccetto imatinib
    b) Evento avverso in corso di grado 3 o 4 correlato a imatinib
    c) Soggetti con evoluzione clonale nelle cellule Ph+ osservata in ≥ 2 metafasi all’esame citogenetico del midollo osseo al baseline, a meno che le stesse anomalie non fossero presenti alla diagnosi (vedere Sezione 5.8.2 per i soggetti esenti dalla valutazione citogenetica del midollo osseo al baseline)
    d) Soggetti con precedente perdita di REC o perdita di risposta citogenetica maggiore (RCgM) sottoposti al trattamento con imatinib
    e) Precedente diagnosi di LMC in fase accelerata o blastica
    2) Anamnesi e malattie concomitanti
    a) Un grave disturbo medico non controllato o un’infezione attiva che potrebbe compromettere la capacità del soggetto di ricevere la terapia del protocollo
    b) Malattia cardiovascolare significativa o non controllata, inclusa una qualsiasi delle seguenti:
    i. Insufficienza cardiaca congestizia (NYHA &gt; 2) nei 3 mesi precedenti
    ii. Sindrome del QT lungo congenita, sospetta o diagnosticata
    iii. Qualsiasi aritmia ventricolare clinicamente significativa nell’anamnesi
    iv. Intervallo QTcF prolungato sull’elettrocardiogramma prima dell’ingresso (&gt; 450 msec)
    v. Anamnesi di blocco cardiaco di secondo o terzo grado (il soggetto può essere eleggibile se attualmente dispone di un pacemaker)
    vi. Angina non controllata nei 3 mesi precedenti
    vii. Infarto del miocardio nei 6 mesi precedenti
    viii. Ipertensione non controllata
    c) Ipertensione arteriosa polmonare nota
    d) Sono esclusi i soggetti con versamenti pleurici o pericardici di qualsiasi grado al momento dell’ingresso nello studio. Sono ammessi i soggetti con precedenti diagnosi di versamenti pleurici/pericardici di qualsiasi grado risolte al momento dell’ingresso nello studio.
    e) Storia di disturbo della coagulazione non correlato alla LMC, inclusi
    i. Disturbi della coagulazione congeniti diagnosticati (ad esempio, malattia di Von Willebrand)
    ii. Disturbo della coagulazione acquisito diagnosticato entro l’anno precedente (ad esempio, anticorpi anti-fattore VIII acquisiti)
    f) Malattia mentale grave che interferisce con la capacità di partecipare allo studio
    3) Risultati degli esami fisici e di laboratorio
    a) Mutazione T315I precedentemente documentata (il reclutamento non dipende dai risultati dell’analisi di mutazione al baseline)
    4) Allergie e reazioni avverse al farmaco
    a) Non applicabile, tranne come notato nel criterio di esclusione 1
    5) Sesso e maturazione sessuale
    a) Pazienti incinta, che allattano al seno o che possono rimanere incinta
    b) Uomini la cui partner non acconsente o non è in grado di evitare una gravidanza
    6) Altri criteri di esclusione
    a) Detenuti o soggetti reclusi contro la propria volontà
    b) Soggetti detenuti in maniera forzosa per il trattamento di una malattia psichiatrica o fisica (ad esempio, malattia infettiva).
    Soggetti che non sono in grado di completare i questionari degli esiti riportati dai pazienti senza assistenza
    E.5 End points
    E.5.1Primary end point(s)
    To assess the rate of MMR after the switch to dasatinib
    Valutazione del rapporto di MMR dopo il passaggio a dasatinib
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 and 12 months after the switch to dasatinib
    Dopo 6 e 12 mesi dal passaggio a dasatinib
    E.5.2Secondary end point(s)
    To assess the rate of MR after the switch to dasatinib
    Valutazione del rapporto di MR dopo il passaggio a dasatinib
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 and 12 months after the switch to dasatinib
    Dopo 6 e 12 mesi dal passaggio a dasatinib
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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.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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Korea, Democratic People's Republic of
    Korea, Republic of
    United States
    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
    LVLS
    LVLS
    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 months0
    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 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.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 75
    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)
    At the end of the study, BMS will not continue to supply study drug to subjects or investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat CML after study completion
    Dopo il completamento dello studio, i pazienti devono continuare a essere trattati secondo lo standard di cura.
    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 Decision2013-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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