Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 to 90 Pharmaceutical / Industry CA180-034 NCT00123474

Trial Description

Summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Eligibility Criteria

Inclusion Criteria:

• Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.

• Men and women, 18 years or older

• Adequate hepatic function

• Adequate renal 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:

• Women who are pregnant or breastfeeding

• Subjects who are eligible and willing to undergo transplantation during the screening period

• 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 or rendering of informed consent

• History of significant bleeding disorder unrelated to CML

• Concurrent incurable malignancy other than 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers Squibb

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00123474
Information obtained from ClinicalTrials.gov on September 26, 2008