Status:
COMPLETED
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are...
Eligibility Criteria
Inclusion
- Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
- Men and women, 18 years of age or older.
- Adequate hepatic function.
- Adequate renal function.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
Exclusion
- Women who are pregnant or breastfeeding.
- Subjects who are eligible and willing to undergo transplantation during the screening period.
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease.
- Medications that increase bleeding risk.
- Medications that change heart rhythms.
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- History of significant bleeding disorder unrelated to CML.
- Concurrent incurable malignancy other than CML.
- Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
- Prior therapy with dasatinib (BMS-354825).
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00101647
Start Date
December 1 2004
End Date
March 1 2008
Last Update
April 15 2011
Active Locations (70)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Anaheim, California, United States
3
Local Institution
Los Angeles, California, United States
4
Local Institution
Stanford, California, United States