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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2008-002260-33
    Sponsor's Protocol Code Number:CA180-226
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-002260-33
    A.3Full title of the trial
    A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemia with Resistance or Intolerance to Imatinib.
    A.4.1Sponsor's protocol code numberCA180-226
    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 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 AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    D.3 Description of the IMP
    D.3.1Product nameBMS-354825-03
    D.3.2Product code BMS-354825-03
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNDasatinib
    D.3.9.1CAS number 863127-77-9
    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 No
    D.3.11.8Extractive medicinal product No
    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 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 AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    D.3 Description of the IMP
    D.3.1Product nameBMS-354825-03
    D.3.2Product code BMS-354825-03
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNDasatinib
    D.3.9.1CAS number 863127-77-9
    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 No
    D.3.11.8Extractive medicinal product No
    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: 3
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    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.3.8INN - Proposed INNDasatinib
    D.3.9.1CAS number 863127-77-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Children and Adolescents with Ph+ Leukemia with Resistance or Intolerance to Imatinib
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10024329
    E.1.2Term Leukemia
    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 is to estimate the MCyR rate to dasatinib therapy in children and adolescents with CP-CML, and the CHR rate in children and adolescents with Ph+ ALL, AP- and BP-CML, who are resistant, intolerant to, or relapse after prior imatinib therapy.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of dasatinib in children and adolescents treated with dasatinib for relapsed or refractory Ph+ leukemias
    • To evaluate additional measures of efficacy in children and adolescents with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including:
    – best cytogenetic and hematological response rates
    – time to response and duration of response
    – progression-free survival (PFS) and overall survival (OS)
    – rates of complete (CMR) and major (MMR) molecular response
    • To describe the spectrum of the BCR-ABL mutations at baseline, at progression or
    end of treatment, and to explore the role of mutations as predictors of response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Written informed consent from subject, or from parents or legal guardians for
    minor subjects, according to local law and regulation.
    2) Target Population
    a) Diagnosis:
    i) Cohort #1: Subjects must have Ph+ CML in CP which is defined by the
    presence of all the following criteria:
    (a) < 15% blasts in peripheral blood and bone marrow
    (b) < 20% basophils in peripheral blood
    (c) < 30% blasts + promyelocytes in peripheral blood and bone marrow
    (d) ≥ 100 X 109 platelets/L unless thrombocytopenia secondary to recent
    treatment
    (e) No extramedullary involvement other than liver or spleen
    (f) Ph+ or variant must be demonstrated by bone marrow cytogenetics
    ii) Cohort #2: Subjects must have Ph+ ALL or Ph+ AP- or BP-CML:
    i. Ph+ ALL have to be in first or subsequent relapse [ ≥ 25% blasts in bone
    marrow] or fail to achieve remission after imatinib
    ii. AP-CML must meet at least one of the following criteria:
    (a) ≥ 15% but < 30% blasts in peripheral blood or bone marrow
    (b) ≥ 30% blasts + promyelocytes in peripheral blood and in bone marrow
    (but percent alone has to be < 30%)
    (c) ≥ 20% basophils in peripheral blood or bone marrow
    (d) < 10 X 109/L platelets unrelated to therapy
    iii. BP-CML has to meet all the following criteria:
    (a) ≥ 30% blasts in peripheral blood or bone marrow
    (b) Presence of extramedullary blastic disease other than lymph nodes,
    liver or spleen
    b) Subjects have to be proven resistant or intolerant to imatinib:
    i) For both cohorts, intolerance to imatinib is defined as the occurrence of any
    toxicity grade ≥ 3 considered at least possibly related to imatinib and that led
    to discontinuation of previous imatinib therapy.
    ii) For Cohort #1, resistance to imatinib must meet at least one of the following
    criteria:
    (a) Failure to achieve, or loss of, CHR after ≥ 3 months of imatinib at a
    daily dose of 260 mg/m2 or greater;
    (b) Failure to achieve MCyR after ≥ 6 months or CCyR after ≥ 12 months
    of imatinib therapy at a daily dose of 260 mg/m2 or greater;
    (c) Absolute increase of ≥ 30% of the percentage of Ph+ metaphases,
    confirmed at ≥ 6 week interval, after prior MCyR to imatinib at a daily
    dose of 260 mg/m2 or greater.
    iii) For Cohort #2, resistance to imatinib must meet at least one of the following
    criteria:
    (a) Failure to achieve CHR while on imatinib after a ≥ 4-week treatment
    or a ≥ 50% increase in peripheral blood blasts over a 2-week period
    (b) Subjects who achieved a CHR subsequently no longer meet the criteria
    consistently over a consecutive 2-week period while receiving imatinib
    (c) Absolute increase of ≥ 30% of the percentage of Ph+ metaphases,
    confirmed at ≥ 6 week interval, after prior MCyR to imatinib.
    c) Lansky or Karnofsky scale > 50 (see Appendix 2)
    d) Life expectancy ≥ 12 weeks
    e) Subjects must have recovered to baseline or Grade 1 (NCI CTCAE, version 3.0)
    from the toxicities (except alopecia) resulting from recent therapies, including
    chemotherapy, hormonal therapy, immunotherapy, biological therapy or
    investigational product and radiation therapy.
    f) Serum Na, K, NaHC03, Mg, P and Ca levels within institutional normal limits
    and AST, ALT, bilirubin, BUN or urea, creatinine ≤ Grade 2 (NCI CTCAE,
    Version 3.0).
    3) Age and Sex
    a) Men and women, age ≥ 1 to < 21 years
    Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 4 weeks after
    the last dose of investigational product in such a manner that the risk of pregnancy
    is minimized.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period and for up to 4 weeks after the last dose of
    investigational product.
    b) Women who are pregnant or breastfeeding
    c) Women with a positive pregnancy test on enrollment or prior to investigational
    product administration.
    d) Sexually active fertile men not using effective birth control if their partners are
    WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period and for up to 4 weeks after the last dose of
    investigational product.
    2) Target Disease Exceptions
    a) Subjects for whom potentially-curative therapy is available, including
    hematopoietic stem-cell transplantation (HSCT)
    b) Symptomatic central nervous system (CNS) involvement (except if signs and
    symptoms are from isolated leptomeningeal disease)
    c) Isolated extramedullary disease, with < 5% blasts in bone marrow
    3) Medical History and Concurrent Diseases
    a) Any serious uncontrolled medical disorder that would impair the ability of the
    subject to receive protocol therapy, including:
    i) Ongoing uncontrolled infection
    ii) Clinically-significant disorder of platelet function (e.g. von Willebrand’s
    disease) or ongoing gastrointestinal bleeding
    iii) Clinically-significant cardiovascular disease, congenital long QT syndrome,
    history of ventricular arrhythmias or heart block, or prolonged QTc interval >
    450 ms (Fridericia correction) on baseline electrocardiogram
    b) Expected non-compliance to protocol schedule or unable to have regular followup
    due to psychological, social, familial or geographic reasons
    4) Prohibited Treatments and/or Therapies
    a) Prior therapy with dasatinib.
    b) Any investigational agent or any other anti-cancer agent within 14 days prior to
    treatment start. Imatinib mesylate may be continued up to 7 days before treatment
    start, or, in the presence of rising peripheral blast cells, imatinib may be continued
    up to 2 days before treatment start. If required for control of peripheral blast cells,
    hydroxyurea, corticosteroids, 6-mercaptopurine or 6-thioguanine may be given up
    to 2 days before treatment start.
    c) Subjects requiring ongoing medications which may:
    i) Have a known risk of causing QTc prolongation - see Section 5.5.3.2
    ii) Irreversibly inhibit platelet function, or anticoagulants - see Section 5.5.3.3
    (Does not apply to low-dose heparin for prophylaxis or to heparin flushes for
    i.v. lines)
    5) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is MCyR for Cohort #1 and CHR for Cohort #2. Cytogenetic response will be based on the percentage of Ph+ metaphases among ≥ 20 analyzed
    metaphases in bone marrow aspirate. CHR will be assessed regularly through serum hematology tests. Molecular responses will also be assessed. Mutation analyses will be reported descriptively.
    To assess safety, adverse events will be reported continuously and graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Safety will be summarized by cohort, by reporting AEs, laboratory abnormalities, dose interruptions and reductions, treatment discontinuation for toxicity, and use of concomitant medications.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 70
    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 Decision2009-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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