Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib

Completed · Phase 2

Conditions studied: Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia

In brief

The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

Key facts

Study ID

NCT00101660

Run by

Bristol-Myers Squibb

People needed

387

Starts

2005-02-01

Expected to finish

2008-04-01

Last updated by the study team

2012-03-02

Who can join

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

You may qualify if…

• Age of 18 years and older.
• Chronic myeloid leukemia (CML)
• Previous treatment with imatinib at a dose of >600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR
• CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR
• Intolerance to imatinib at any dose
• Adequate organ function
• Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.

You may not qualify if…

• Woman who are pregnant or breastfeeding
• Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
• Previous diagnosis of accelerated phase or blast crisis CML.
• Participants who are eligible and willing to undergo transplantation during the screening period
• Uncontrolled or significant cardiovascular disease
• Use of imatinib within 7 days.
• Use of interferon or cytarabine within 14 days
• Use of a targeted small-molecule anticancer agent within 14 days
• Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants
• Prior therapy with dasatinib.

Where it is running

• Local Institution — Loma Linda, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Stanford, California, United States
• Local Institution — Vallejo, California, United States
• Local Institution — Hartford, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, 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 — Indianapolis, Indiana, 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 — Kansas City, Missouri, United States
• Local Institution — St Louis, Missouri, United States
• Local Institution — Omaha, Nebraska, 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 — Philadelphia, Pennsylvania, United States
• Local Institution — Pittsburgh, Pennsylvania, United States
• Local Institution — Anaheim, California, United States

Full record on ClinicalTrials.gov

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