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

Leukemia, Myeloid, Chronic-phase Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103701
• Other study ID #: CA180-002
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2005
• Last updated: April 13, 2011
• Start date: November 2003
• Est. completion date: March 2006

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blast Crisis
• Leukemia
• Leukemia, Lymphoblastic, Acute, Philadelphia-positive
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Local Institution	Houston	Texas
United States	Local Institution	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of MTD and recommended Phase II dose.
Secondary	1) Hematologic Response 2) Cytogenetic Response.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm