Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

• Status: Completed
• Trial end date: 2015-05-27
• Target enrollment: 0
• Participant gender: All

Summary

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.

• Diagnosis of CML chronic phase confirmed.

• Adequate hepatic and renal function.

• Able to take oral tablets.

Exclusion Criteria:

• Exclusions include Philadelphia negative CML.

• Prior anti-leukemia treatment.

• Prior stem cell transplant.