BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00103701

Collaborator

(none)

Locations

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic-phase Leukemia, Lymphoblastic, Acute, Philadelphia-positive	Drug: Dasatinib	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Dasatinib Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response. Other Names: Sprycel

Arm

Intervention/Treatment

Experimental: 1

Drug: Dasatinib

Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.

Other Names:

Sprycel

Outcome Measures

Primary Outcome Measures

Establishment of MTD and recommended Phase II dose. []

Secondary Outcome Measures

1) Hematologic Response 2) Cytogenetic Response. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
Men and women, 14 years of age or older.
Adequate renal function.
Adequate hepatic function.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

Patients who are eligible and willing to undergo transplantation during the screening period.
Women who are pregnant or breastfeeding.
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
Uncontrolled or significant cardiovascular disease.
Medications that increase bleeding risk.
Medications that change heart rhythms.
Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
History of significant bleeding disorder or unrelated to CML.
Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.