Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

Inclusion Criteria:

Males or females who are 18 years or older
Able to swallow capsules
Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer
Able to discontinue all anticancer therapies 2 weeks prior to study start
Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors
Life expectancy of at least 3 months
ECOG performance status of 0 or 1
Provide written informed consent

Exclusion Criteria:

Primary brain tumors or clinical evidence of active brain metastasis
Systemic corticosteroid use within 7 days before planned start of study therapy
Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy
Uncontrolled diabetes as assessed by the investigator
Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus
History of bone marrow of solid organ transplantation
History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes
Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside
Pregnant, planning a pregnancy or breast feeding during the study
Concurrent participation in another therapeutic clinical trial