NCT00103844

Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Conditions

• Chronic Myeloid Leukemia
• Philadelphia-Positive Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
DRUG	Imatinib	Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-08-01
• Completion: 2008-03-01
• First posted: 2005-02-16
• Last updated: 2010-08-10
• Results posted: 2010-01-07

Locations

131 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Norway, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom