Inclusion Criteria

Key Inclusion Criteria (Part 1):

- Histologically or cytologically confirmed diagnosis of a solid tumor suitable for
treatment with gemcitabine.

- No more than 3 prior anticancer regimens for advanced disease.

- Measurable or evaluable, nonmeasurable disease.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Able to take and retain oral medications.

- Additional criteria exist.

Key Exclusion Criteria (Part 1):

- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and
is on steroids, the steroid dose must have been stable for at least 30 days).

- Treatment with prior chemotherapy within 21 days of first dose of study drug.

- Requiring IV alimentation.

- Pregnancy or lactation.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B
and/or hepatitis C.

- History of being unable to tolerate gemcitabine or any of its components.

- Additional criteria exist.