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    Summary
    EudraCT Number:2004-002601-69
    Sponsor's Protocol Code Number:CA180-013
    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:2005-11-04
    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 number2004-002601-69
    A.3Full title of the trial
    A Phase II Study to Determine the Activity of BMS-354825 in Subjects with Chronic
    Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have
    Disease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who are
    Intolerant of Imatinib
    A.4.1Sponsor's protocol code numberCA180-013
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameBMS-354825-03
    D.3.2Product code BMS-354825-03
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBMS-354825-03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    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 nameBMS-354825-03
    D.3.2Product code BMS-354825-03
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBMS-354825-03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Chronic phase Philadelphia chromosome-positive chronic myeloid leukemia
    MedDRA Classification
    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 estimate the major cytogenetic response (MCyR) rate to BMS-354825 in subjects with Philadelphia chromosome positive chronic phase Ph+ CML who have disease that is resistant to high dose imatinib (primary resistance, acquired resistance or mutation highly associated with imatinib resistance).
    E.2.2Secondary objectives of the trial
    1) To estimate the MCyR rate in the imatinib-intolerant subjects.
    2) To assess the durability of MCyR and time to MCyR in the imatinib-resistant and the imatinib-intolerant groups
    3) To estimate complete hematologic response (CHR) rate, duration of CHR and time to CHR in the imatinib-resistant and the imatinib-intolerant groups
    4) To estimate major molecular response rate in the imatinib-resistant and the imatinib-intolerant groups
    5) To assess the health-related quality of life using the FACT-G
    6) To assess further the safety and tolerability of BMS-354825
    7) To collect blood samples for pharmacokinetic analysis of BMS-354825 given BID
    that will contribute to population pharmacokinetic modeling.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Available for periodic follow-up
    2) Life expectancy of at least approximately 3 months
    3) ECOG performance status score 0-1
    4) Subjects with chronic phase Ph+ CML, defined as a myeloproliferative disorder with evidence of a Philadelphia chromosome on cytogenetic analysis. Subjects meeting all of the following criteria will be classified as having chronic phase CML:
    • < 15% blasts in peripheral blood and in bone marrow
    • < 20% basophils in peripheral blood
    • < 30% blasts + promyelocytes in peripheral blood and in bone marrow
    • Platelets ≥ 100,000/mm3 unless thrombocytopenia is due to recent therapy
    • No extramedullary involvement (other than liver or spleen)
    5) Subjects must fulfill at least one of the following criteria relating to prior treatment
    with imatinib:
    A. Previously been treated with imatinib at a dose of > 600 mg/day AND developed
    progressive disease while receiving imatinib at that dose.
    B. CML with resistance to imatinib ≤600 mg/d with genetic mutation in the BCR-ABL
    gene that is associated with a high level of resistance to imatinib.
    C. Intolerant of imatinib at any dose.
    6) Adequate hepatic function defined as:
    • total bilirubin ≤ 2.0 times the institutional upper limit of normal
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤
    2.5 times the institutional upper limit of normal
    7) Adequate renal function defined as:
    • serum creatinine ≤ 1.5 times the institutional upper normal limit
    8) Serum potassium and magnesium levels within institutional normal limits. Total
    serum calcium or ionized calcium level must be greater than or equal to the lower
    limit of normal.
    9) Men and women, ages 18 years of age or older.
    E.4Principal exclusion criteria
    1) Women who are pregnant or breastfeeding.
    2) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period of at least 1 month before and at least 3 months
    after completion of the study medication.
    3) Previous diagnosis of accelerated phase or blast crisis CML
    4) Subjects who are eligible and willing to undergo transplantation during the screening period
    5) A serious uncontrolled medical disorder or active infection that would impair the
    ability of the subject to receive protocol therapy.
    6) Uncontrolled or significant cardiovascular disease
    7) History of significant bleeding disorder unrelated to CML,
    8) Concurrent incurable malignancy other than CML.
    9) Evidence of organ dysfunction or digestive dysfunction that would prevent
    administration of study therapy
    10) Subjects who received
    a) imatinib within 7 days
    b) interferon or cytarabine within 14 days
    c) a targeted small molecule anti-cancer agent within 14 days,
    d) any other investigational or antineoplastic agent other than hydroxyurea or
    anagrelide within 4 weeks before starting treatment with BMS-354825
    11) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsade de Pointes.
    12) Subjects taking medications that irreversibly inhibit platelet function
    13) Subjects taking medications known to be potent CYP3A4 inhibitors or inducers
    14) Prior therapy with BMS-354825.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:

    The primary endpoint of this Phase II study is to estimate MCyR rate to BMS-
    354825 in treated subjects with chronic phase Ph+ CML who have resistance to high dose imatinib (primary resistance, acquired resistance or mutation highly associated with imatinib resistance).

    Secondary endpoints include duration of MCyR, time to MCyR, complete hematologic response (CHR) rate, duration of CHR, time to CHR, major molecular response rate and BCR/ABL mutational analysis, in addition to health-related quality of life, safety and collection of samples to contribute to population pharmacokinetic modeling. A separate calculation of response rates will be performed for the imatinib-intolerant group at the time of the primary analysis for the imatinib-resistant subjects.

    Safety:

    Evaluation of safety will be a secondary endpoint of this study. For safety evaluation,
    toxic effects will be assessed continuously. All subjects who receive any study drug will be evaluable for toxicity. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

    The criteria for all the primary and secondary endpoints are defined in Protocol Section 3.3.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory biomarkers and Outcomes research assessment (Health re. quality of life questionnaire)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Treatment will continue until disease progression, unacceptable toxicity, subject
    withdrawal or discontinuation of the study. Follow-up visits after last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline or (≤ CTC Grade 1), stabilize, or are deemed irreversible.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 250
    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 Decision2005-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-07
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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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