Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

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