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

NCT ID: NCT00103701

Last Updated: 2011-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2006-03-31

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).

Conditions

Leukemia, Myeloid, Chronic-phase; Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

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

Interventions

Dasatinib

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

Intervention Type: DRUG

Other Intervention Names

Sprycel

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Los Angeles, California, United States

Local Institution

Houston, Texas, United States

Countries

United States

Other Identifiers

CA180-002

Identifier Type: -

Identifier Source: org_study_id