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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Maebashi, Gunma, Japan
Local Institution
Nishinomiya-Shi, Hyōgo, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Isehara-Shi, Kanagawa, Japan
Local Institution
Kanagawa, Kanagawa, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
...and 11 more locations
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
response
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