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    Summary
    EudraCT Number:2005-005153-22
    Sponsor's Protocol Code Number:CA180-043
    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:2010-03-12
    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 number2005-005153-22
    A.3Full title of the trial
    An open-label, randomized study of dasatinib vs. high-dose (800 mg) imatinib in the treatment of subjects with chronic phase chronic myeloid leukemia who have had a suboptimal response after at least 3 months of therapy with 400 mg imatinib.
    Estudio aleatorizado, abierto, de dasatinib frente a imatinib, a dosis altas (800 mg), en el tratamiento de sujetos con leucemia mieloide crónica, en fase crónica, con respuesta subóptima a imatinib 400 mg después de, al menos, 3 meses de tratamiento.

    Revised Protocol 02, incorporating Administrative Letter 01 and Protocol Amendments 02 (Version 1.0, Dated 29-May-2007) & 3 (Version 1.0, Dated 10-Oct-2007).
    A.4.1Sponsor's protocol code numberCA180-043
    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/3/05/339
    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.3.9.2Current 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 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/3/05/339
    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.3.9.2Current 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 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 RoleComparator
    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 Gleevec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGleevec
    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 INNImatinib free base
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Gleevec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGleevec
    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 INNImatinib free base
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Subjects with Ph+ chronic phase Chronic Myeloid leukemia (CML).
    Sujetos con Leucemia Mieloide Crónica en fase crónica con cromosoma Philadelphia Positivo.
    MedDRA Classification
    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 rate of major molecular response of dasatinib (100 mg QD) to high-dose imatinib (800 mg, i.e. 400 mg BID) therapy at 12 months in chronic phase CML subjects, who had achieved only a suboptimal response after at least 3 months imatinib (400 mg) monotherapy prior to enrollment. A suboptimal response is defined as a hematologic response but less than Complete HR after at least 3 months; a cytogenetic response but less than a partial cytogenetic response (PCgR) after at least 6 months; a partial cytogenetic response after at least 12 months, or less than a major molecular response with complete cytogenetic response after at least 18 months.

    Additional 12 months of treatment:
    The primary objective is to collect longer term efficacy on dasatinib in terms of duration of major molecular response.

    E.2.2Secondary objectives of the trial
    • To estimate the rates of Complete Cytogenetic Response (CCgR) at months 6 and 12 in both treatment arms
    • To estimate the time to Major Molecular Response (MMolR) and TTF, PFS in both treatment arms
    • To assess the safety of dasatinib and high-dose imatinib
    • To establish BCR/ABL kinase domain mutation rate
    • To investigate causes and mechanisms of resistance
    • To evaluate the quality of life (QOL) in each treatment arm

    Additional 12 months of treatment:
    The secondary objective is to provide access to study treatment for those patients who are benefiting from 800 mg imatinib and to obtain further safety data.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects able to provide written informed consent
    2) Available for periodic follow up
    3) Life expectancy of at least approximately 3 months

    Target population
    4) Subjects with Ph+ chronic phase CML who achieved only a suboptimal response (defined as a HR which is <CHR after at least 3 months therapy with imatinib 400 mg
    monotherapy; a CgR which is <PCgR after at least 6 months therapy with imatinib
    400 mg monotherapy; a PCgR after at least 12 months therapy with imatinib 400 mg monotherapy or less than MMolR with CCgR after at least 18 months therapy with imatinib 400 mg monotherapy). Only subjects who started treatment with imatinib 400 mg monotherapy within 6 months of initial CML diagnosis will be eligible.
    5) ECOG performance status (PS) score 0 - 2 (See Protocol Appendix 1)
    6) Adequate hepatic function defined as:
    - total bilirubin ≤2.0 times the institutional ULN;
    - alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN
    7) Adequate renal function defined as: serum creatinine ≤3 times the institutional ULN.
    8) 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.

    Age and Sex
    9) Men and women, 18 years of age and older
    10) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
    11) WOCBP 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 study medication.

    The following subjects are considered to be eligible for the additional 12 months of
    treatment:
    • Subjects with a MMolR after initial 12 months of treatment on either dasatinib or
    800 mg imatinib. Subjects who obtain their first MMolR at month 12, should have
    this response confirmed at month 13 in order to be eligible to the second year of the study.
    E.4Principal exclusion criteria
    Sex and Reproductive Status
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least one month before and for at least 3 months after completion of study medication.
    2) Women who are pregnant or breastfeeding
    3) Women with a positive pregnancy test on enrollment or prior to study drug administration.
    4) Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.

    Target Disease Exceptions
    5) Subjects eligible for immediate autologous or allogeneic stem cell transplantation.
    6) Previous diagnosis of accelerated phase or blast crisis CML
    7) Subjects who have previously documented T315I mutation.
    Screening for mutation is not required for enrollment onto the protocol.
    8) Subjects with a MMolR
    9) Subjects with no hematologic response
    10) Subjects who lost previously documented CHR, PCgR or CCgR

    Medical History and Concurrent Diseases
    11) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
    12) Uncontrolled or significant cardiovascular disease, including:
    a) A myocardial infarction within 6 months
    b) Uncontrolled angina within 3 months
    c) Congestive heart failure within 3 months
    d) Diagnosed or suspected congenital long QT syndrome
    e) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
    f) Prolonged QTc interval > 500 msec on pre-entry ECG according to Fridericia formula
    g) Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
    h) Heart rate consistently < 50 beats/minute on pre-entry ECG
    i) Uncontrolled hypertension
    13) History of significant bleeding disorder unrelated to CML, including:
    a) Diagnosed congenital bleeding disorders
    b) Diagnosed acquired bleeding disorder within one year
    c) Clinically significant bleeding from the GI tract within 6 months
    14) Concurrent other malignancies other than CML

    Physical and Laboratory Test Findings
    15) Intolerance to imatinib 400 mg. Intolerance is defined as occurrence of any of the following at any time during treatment
    a) Imatinib-related grade 3 or greater non-hematologic toxicity
    b) Imatinib-related grade 4 hematologic toxicity lasting more than 7 days
    c) Imatinib-related toxicity leading to imatinib discontinuation or disruption in dosing for >4 weeks

    Prohibited Therapies and/or Medications
    16) Prior treatment with imatinib at a dose > 400 mg
    17) Less than 3 months of prior treatment with imatinib
    18) Time from initial diagnosis of CML to start of first imatinib dose > 6 months
    19) Subjects with prior stem cell transplantation and/or high dose chemotherapy for CML
    20) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
    - quinidine, procainamide, disopyramide
    - amiodarone, sotalol, ibutilide, dofetilide
    - erythromycins, clarithromycin
    - chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone
    - cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
    Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of dasatinib.
    21) Subjects taking medications that inhibit platelet function or anticoagulants (Low-dose warfarin for prophylaxis to prevent catheter thrombosis, and heparin-flushes for IV lines is permitted);
    22) Prior therapy with dasatinib or other experimental agent for CML

    Other Exclusion Criteria
    23) Prisoners or subjects who are involuntarily incarcerated. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    • Primary endpoint: proportion of subjects achieving a MMolR rate at 12 months
    • Secondary endpoints: CCgR rate at 6 and 12 months, time to MMolR, TTF and PFS.

    Subjects who have a confirmed MMolR at 12 months on treatment will be counted as responders (if first MMolR is at month 12, the confirmed MMolR should occur at month 13). Treatment failure will be defined as failure to complete 12 months of treatment or failure to achieve a MMolR at 12 months of study treatment. Subjects who achieved a MMolR earlier than 12 months, but have lost this response at evaluation at 12 months, will not be considered responders.

    Safety:
    Safety and tolerability of dasatinib and imatinib will be reported for all randomized subjects. Adverse events will be assessed continuously and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Mutation and resistance analysis:
    Mutation analysis will be performed in all subjects at baseline, at the time of progression during study treatment or after 12 months of treatment.
    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 Yes
    E.6.13.1Other scope of the trial description
    BCR/ABL kinase mutation rate analysis; Health Utility Assessment (QoL)
    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 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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 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
    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 months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 168
    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 12-month treatment period, subjects on the dasatinib arm who might benefit from further treatment with dasatinib will be offered the possibility to participate in a roll-over study.
    At the end of the 12-month treatment period, subjects on the imatinib arm who might benefit from further treatment with > 400 mg imatinib, will be offered the possibility to participate in a roll-over study, since doses > 400 mg are actually not approved in Europe for this patient population.
    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 Decision2006-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-15
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