Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 20 to 75 Pharmaceutical / Industry CA180-031 NCT00337454

Trial Description

Summary

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Eligibility Criteria

Inclusion Criteria:

• Philadelphia chromosome positive or bcr-abl gene positive

• Chronic Myelogenous Leukemia (CML)

• Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate

• Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)

• Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy

• Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2

• Men and women, ages 20 - 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 or ALL

• Adequate hepatic function

• Adequate renal function

• Medication that increase bleeding risk

• Medication that change heart rhythms

• Subjects who are compulsorily detained for legal reasons or 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

Taku Seriu, MD, PhD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00337454
Information obtained from ClinicalTrials.gov on July 15, 2008