Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA

Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

Inclusion Criteria:

• Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
• Age ≥20 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Adequate Liver and Renal Function

Exclusion Criteria:

• Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
• Any past or current CNS involvement, including leptomeningeal leukemia
• Extramedullary disease only
• Major surgery or radiotherapy within 14 days prior to registration
• History of clinically significant or uncontrolled cardiac disease
• Patients with active, uncontrolled bacterial, fungal, or viral infection
• Recent or ongoing clinically significant GI disorder
• History of another malignancy within 5 years prior to registration
• Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
• Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
• Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
• Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
• Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study