Status:
COMPLETED
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Myeloid Leukemia
Blast Crisis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either r...
Eligibility Criteria
Inclusion
- Subjects with myeloid blast phase chronic myeloid leukemia
- Subjects who are either resistant or intolerant of imatinib mesylate
Exclusion
- Subjects who are eligible and willing to undergo transplantation
- Serious uncontrolled medical disorder or active infection
- Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
- Subjects receiving medications that may affect heart rhythm
- Other malignancy/cancer other than CML
- History of significant bleeding disorder unrelated to CML
- Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
- Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
- Subject is receiving medications that affect platelet function or an anticoagulant
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00101816
Start Date
December 1 2004
End Date
March 1 2008
Last Update
August 10 2010
Active Locations (62)
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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