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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337454

CA180-031

Details and patient eligibility

About

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)

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

A1

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

A2

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

A3

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

B1

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

B2

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

B3

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib