Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)

Inclusion Criteria:

- Have Philadelphia chromosome positive chronic myelogenous leukemia (CML) in chronic
phase, as per IBMTR criteria

- Have documented hematologic resistance to Gleevec (Imatinib) following a prior
hematologic response to Gleevec administered at doses of at least 400 mg/d for at
least 3 months.

- Have WBC >20 x 109/L at study entry

- Have an ECOG performance status. Status of 0, 1 or 2

- Have an anticipated survival of at least 16 weeks.

- Be able to comply with study procedures and follow-up examinations.

- Signed informed consent must be obtained prior to any study specific procedures.

Exclusion Criteria:

- Congestive heart failure > class II as defined by the New York Heart Association
Functional Classification (NYHA)

- Cardiac arrhythmias requiring antiarrythmics (excluding beta blockers or digoxin)

- Active coronary artery disease or ischemia

- History of HIV infection or chronic hepatitis B or C

- Active clinically serious infections (> grade 2 NCI-CTC)

- Patients with seizure disorder requiring anti-epileptic drugs

- History of solid organ allograft