Trials / Completed
CompletedNCT00123487
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 638 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dasatinib | Tablets, Oral, 70 mg BID, indefinitely, survival study |
| DRUG | dasatinib | Tablets, Oral, 140 mg QD, indefinitely, survival study |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2006-11-01
- Completion
- 2013-06-01
- First posted
- 2005-07-25
- Last updated
- 2014-11-03
- Results posted
- 2014-10-22
Locations
119 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom
Source: ClinicalTrials.gov record NCT00123487. Inclusion in this directory is not an endorsement.