NCT00101660

Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib

A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

Conditions

• Chronic Myeloid Leukemia
• Philadelphia-Positive Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets; oral; 70 mg BID, depending on response

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-09-01
• Completion: 2008-04-01
• First posted: 2005-01-13
• Last updated: 2012-03-02
• Results posted: 2010-02-24

Locations

85 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Peru, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom