Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan

A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Inclusion Criteria:

• Philadelphia chromosome positive or bcr-abl gene positive
• Chronic Myelogenous Leukemia (CML)
• Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
• Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
• Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
• Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
• Men and women, ages 20 - 75
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

• Subjects who are eligible and willing to undergo transplantation at pre-study
• Women who are pregnant or breastfeeding
• Uncontrolled or significant cardiovascular disease
• History of significant bleeding disorder unrelated to CML or ALL
• Adequate hepatic function
• Adequate renal function
• Medication that increase bleeding risk
• Medication that change heart rhythms
• Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study