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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Experimental |
| |
| A3 | Experimental |
| |
| B1 | Experimental |
| |
| B2 | Experimental |
| |
| B3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 50mg BID, once daily, 24 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Local Institution |
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| Dasatinib | Drug | Tablets, Oral, 70mg BID, once daily, 24 weeks. |
|
|
| Dasatinib | Drug | Tablets, Oral, 90mg BID, once daily, 24 weeks. |
|
|
| Dasatinib | Drug | Tablets, Oral, 70mg BID, once daily, 24 weeks. |
|
|
| Dasatinib | Drug | Tablets, Oral, 70mg BID, once daily, 12 weeks. |
|
|
| Dasatinib | Drug | Tablets, Oral, 70mg BID, once daily, 12 weeks. |
|
|
| Nagoya |
| Aichi-ken |
| 466-8550 |
| Japan |
| Local Institution | Nagoya | Aichi-ken | 467-8602 | Japan |
| Local Institution | Maebashi | Gunma | 371-0821 | Japan |
| Local Institution | Nishinomiya-Shi | Hyōgo | 663-8501 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 890-0064 | Japan |
| Local Institution | Isehara-Shi | Kanagawa | 259-1193 | Japan |
| Local Institution | Kanagawa | Kanagawa | Japan |
| Local Institution | Kyoto | Kyoto | Japan |
| Local Institution | Sendai | Miyagi | Japan |
| Local Institution | Nagasaki | Nagasaki | Japan |
| Local Institution | Okayama | Okayama-ken | 700-0082 | Japan |
| Local Institution | Moriguchi | Osaka | 570-8540 | Japan |
| Local Institution | Iruma-Gun | Saitama | 350-0495 | Japan |
| Local Institution | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Local Institution | Tochigi | Tochigi | 329-0498 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-8677 | Japan |
| Local Institution | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 162-8666 | Japan |
| Local Institution | Tokyo | Tokyo | Japan |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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