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). Revised protocol 06 incorporating administrative letters 01, 02, 03, 04 and 05 and amendments 01, 02, 03, 04 and 05 (v1.0 dated 14 Sep 2010).
- Conditions
- Subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia who are resistant or intolerant to imatinib mesylate.MedDRA version: 14.1Level: HLTClassification code 10024296Term: Leukaemias chronic myeloidSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-001294-99-IT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method