Trial Information
A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
Inclusion Criteria:
- 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 Criteria:
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence and severity of drug-related adverse events.
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Belgium: Institutional Review Board
Study ID:
CA180-083
NCT ID:
NCT00349518
Start Date:
December 2006
Completion Date:
Related Keywords:
- Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Chronic and Advanced Phase CML and
- Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome