Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer

Intervention(s):

  • Drug: Bosutinib
  • Drug: imatinib

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting