NCT00101816

Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

Conditions

• Chronic Myeloid Leukemia
• Blast Crisis

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-08-01
• Completion: 2008-03-01
• First posted: 2005-01-14
• Last updated: 2010-08-10
• Results posted: 2010-03-02

Locations

62 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Philippines, Singapore, South Korea, Sweden, Switzerland, Taiwan, United Kingdom