Status:
COMPLETED
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Lead Sponsor:
Pfizer
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chro...
Eligibility Criteria
Inclusion
- 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.
- At least 3 months post stem cell transplantation
- Able to take daily oral capsules/tablets reliably
Exclusion
- Subjects with Philadelphia chromosome, and bcr-abl negative CML
- Overt leptomeningeal leukemia
- Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
Key Trial Info
Start Date :
January 18 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2015
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT00261846
Start Date
January 18 2006
End Date
August 6 2015
Last Update
July 27 2017
Active Locations (111)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
HealthONE Presbyterian
Denver, Colorado, United States, 80218
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
4
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007