Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Condition: Leukemia, Chronic Myelogenous
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Bosutinib
Intervention description: All patients will receive bosutinib at a starting dose of 400 mg QD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Leukemia, Chronic Myelogenous

Summary:

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

Eligibility criteria:

        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