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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Chronic Myeloid Leukemia

Blast Crisis

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101816

CA180-006

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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