| Exclusion Criteria: | 1) Have not recovered to Grade (0 or 1) toxicity from previous anti-cancer treatments or previous investigational agents
2) Received investigational agents within 28 days of first day of study
3) Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or skull, </= 4 weeks or recieved low dose palliative radiation therapy limited to limbs </= 1 week prior to starting study drug, or who have not recovered from side effects of such therapy
4) Currently taking or having received hormones (e.g. estrogen or progesterone) within 7 days prior to the first dose of drug. Note: LHRH analogs are permissible
5) Using moderate or strong CYP450 34A modulators (inducers or inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) prior to Day 1 of dosing and during the study
6) Pregnant or breast-feeding
7) Major surgery within 4 weeks prior to Day 1 of dosing
8) Major surgery to the upper gastrointestinal tract, or have a history of inflammatory bowel disease, malabsorption syndrome or other medical condition that may interfere with oral drug absorption
9) Signs or symptoms of other major diseases including, but not limited to: end organ failure, major chronic illnesses other than cancer, coagulation disorders, hemolytic conditions (e.g. sickle cell disease ) or active infections which, in the opinion of the investigator, makes it undesirable for the subject to participate in the study
10) History of major cardiac or neurologic disease including but not limited to angina pectoris, symptomatic coronary artery disease, uncontrolled hypertension (at time of dosing), NYHA Class III or IV congestive heart failure, confirmed significant cardiac conduction abnormalities (including QTc>0.45 sec) or arrhythmias, myocardial infarction within 12 months, cerebrovascular accidents, or transient ischemic attacks
11) Other conditions which could jeopardize the patientfs ability to comply wiith the protocol including but not limited to dementia, psychosis, or other major psychiatric disorder
12) Known history of hepatitis B, C, or human immunodeficiency (HIV) infection. |