Status:
WITHDRAWN
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia...
Eligibility Criteria
Inclusion
- Males and females, 18 or older
- CP or AD CML or Ph+ ALL
- Intolerant of resistant to imatinib
- ECOG PS 0-2 (CP CML)
- ECOG PS 0-3 (AD CML and Ph+ ALL)
- Adequate hepatic and renal function
Exclusion
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00349518
Start Date
December 1 2006
Last Update
February 17 2016
Active Locations (20)
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1
Local Institution
Budapest, Hungary
2
Local Institution
Bologna, Italy
3
Local Institution
Orbassano (To), Italy
4
Local Institution
Roma, Italy