Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia

A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

Inclusion Criteria:

• Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
• Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
• Men and women, 18 years of age or older.
• Adequate hepatic function.
• Adequate renal function.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Subjects who are eligible and willing to undergo transplantation during the screening period.
• A serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
• Uncontrolled or significant cardiovascular disease.
• Medications that increase bleeding risk.
• Medications that change heart rhythms.
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• History of significant bleeding disorder unrelated to CML.
• Concurrent incurable malignancy other than CML.
• Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
• Prior therapy with dasatinib (BMS-354825).
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.