A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myeloid Leukemia, Chronic

Treatments

Drug: dasatinib

Drug: Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00482703

CA180-138

Details and patient eligibility

About

The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)

Enrollment

23 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
Men and women, ages 20 to 75
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion criteria

Subjects who are eligible and willing to undergo transplantation at pre-study
Women who are pregnant or breastfeeding
Uncontrolled or significant cardiovascular disease
History of significant bleeding disorder unrelated to CML
Adequate hepatic function
Adequate renal function
Medication that increases bleeding risk
Medication that changes heart rhythms
Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study