drugset / Trial / NCT00337454
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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)
Timeline
- Start
- 2005-07
- Primary completion
- 2007-03
- Completion
- 2007-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dasatinib anhydrous | Small molecule | 50 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 70 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 90 mg | Oral |