A Phase II Study of Dasatinib in Children and Adolescents with Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib.

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• ) Sex and Reproductive Status a) WOCBP who are unwilling or unable to use a highly effective method to avoid pregnancy for the entire study period and for up to 1 month after the last dose of investigational product. b) Women who are pregnant or breastfeeding or likely to become pregnant 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) at the time when subject is assessed for enrollment b) Subjects with isolated central nervous system disease are excluded from study. Subjects with CNS-1 (no detectable blast cells in a sample of cerebrospinal fluid), CNS-2 (< 5 leukemic blast cells in a sample with < 10 erythrocytes per cubic millimeter) and CNS-3 disease (> 5 leukemic blasts per cubic millimeter in a sample with < 10 erythrocytes per cubic millimeter) are eligible for study, 28 provided this is a combined relapse which also involves the bone marrow in addition to CNS and they are asymptomatic (no convulsions or other neurological symptoms). c) Isolated extramedullary disease, with < 5% blasts in bone marrow
• ) Medical History and Concurrent Diseases a) Any serious uncontrolled medical disorder that would impair the XML File Identifier: z6kdvfPhIIlyNDn6+JcpAPdG1JU= Page 25/41 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 iv) Subjects diagnosed with the T315I mutation (mutation testing prior to inclusion is highly recommended but is not mandatory at sites without BCR-ABL testing available). v) Subjects who have experienced hypersensitivity to dasatinib or to any of the excipients. Inactive ingredients in dasatinib tablets include: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol. vi) Subjects with hereditary problems of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption. vii) Uncorrected hypokalemia or hypomagnesemia. 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. i) 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. ii) If required for control of peripheral blast cells or WBCs, 6- mercaptopurine or 6-thioguanine may be given up to 2 days before treatment start and corticosteroids or hydroxyurea can be given during the period immediately prior to treatment start and during the first month of study therapy, these agents will be discontinued (or tapered in the case of corticosteroids) as soon as possible. c) Subjects requiring ongoing medications which may: i) Have a known risk of causing QTc prolongation - see Section 5.5.1.2 ii) Irreversibly inhibit platelet function, or anticoagulants - see Section 5.5.1.3 (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