Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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 resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

Inclusion Criteria:

• Subjects with myeloid blast phase chronic myeloid leukemia

• Subjects who are either resistant or intolerant of imatinib mesylate

Exclusion Criteria:

• 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