NCT00101647

Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Myelogenous Leukemia

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: 2005-01-13
• Last updated: 2011-04-15
• Results posted: 2010-03-02

Locations

70 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Peru, Philippines, Singapore, South Korea, Sweden, Switzerland, Taiwan, Thailand, United Kingdom