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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00101647 |
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.
Condition | Intervention | Phase |
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Chronic Myelogenous Leukemia |
Drug: Dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate |
Enrollment: | 194 |
Study Start Date: | December 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dasatinib
Tablets, Oral, 70 mg, twice daily, until disease porgression or untolerable toxicity, switch to the roll-over study or study closure
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA180-005 |
Study First Received: | January 12, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00101647 |
Health Authority: | United States: Food and Drug Administration |
Chronic myelogenous leukemia (CML): Accelerated phase |
Imatinib Leukemia Chronic myelogenous leukemia Hematologic Diseases Leukemia, Myeloid, Accelerated Phase |
Dasatinib Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |