A clinical trial to see the effect of SKI-606 in Philadelphia Chromosome Positive Leukemias
Phase 1
Completed
- Conditions
- Health Condition 1: null- Leukemia, Myeloid, Philadelphia Positive
- Registration Number
- CTRI/2009/091/000583
- Lead Sponsor
- Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 570
Inclusion Criteria
1. Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
2.At least 3 months post stem cell transplantation
3.Able to take daily oral capsules/tablets reliably
Please note: there is no upper age limit for inclusion criteria for this trial
Exclusion Criteria
1.Subjects with Philadelphia chromosome, and bcr-abl negative CML
2.Overt leptomeningeal leukemia
3.Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method