NCT00123474

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Conditions

• Myeloid Leukemia, Chronic, Chronic-Phase

Interventions

Type	Name	Description
DRUG	dasatinib	Tablets, Oral, 50 mg BID, indefinitely, survival study
DRUG	dasatinib	Tablets, Oral, 70 mg BID, indefinitely, survival study
DRUG	dasatinib	Tablets, Oral, 100 mg QD, indefinitely, survival study
DRUG	dasatinib	Tablets, Oral, 140 mg QD, indefinitely, survival study

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-09-01
• Completion: 2014-07-01
• First posted: 2005-07-25
• Last updated: 2016-08-25
• Results posted: 2015-08-26

Locations

137 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom