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

Completed · Phase 2

Conditions studied: Chronic Myeloid Leukemia, Blast Crisis

In brief

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.

Key facts

Study ID

NCT00101816

Run by

Bristol-Myers Squibb

People needed

124

Starts

2004-12-01

Expected to finish

2008-03-01

Last updated by the study team

2010-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with myeloid blast phase chronic myeloid leukemia
• Subjects who are either resistant or intolerant of imatinib mesylate

You may not qualify if…

• 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

Where it is running

• Local Institution — Anaheim, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Stanford, California, United States
• Local Institution — Vallejo, California, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Atlanta, Georgia, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Kansas City, Kansas, United States
• Local Institution — Baltimore, Maryland, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Detroit, Michigan, United States
• Local Institution — St Louis, Missouri, United States
• Local Institution — Hackensack, New Jersey, United States
• Local Institution — New Brunswick, New Jersey, United States
• Local Institution — New York, New York, United States
• Local Institution — Portland, Oregon, United States
• Local Institution — Pittsburgh, Pennsylvania, United States
• Local Institution — Nashville, Tennessee, United States
• Local Institution — Houston, Texas, United States
• Local Institution — Seattle, Washington, United States
• Local Institution — Adelaide, South Australia, Australia
• Local Institution — Vienna, Austria
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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