A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Incurable advanced solid tumors that are no longer responding to conventional therapy
or for which no effective therapy exists; at the RD of Part 1, an extension cohort up
to 20 patients with metastatic breast cancer who are known to be BRCA mutation
carriers will be enrolled.

- Age 18 years or older

- ECOG 0-2

- Life expectancy ≥ 3 months

- Evaluable disease

- Adequate bone marrow function

- Adequate renal function

- Adequate liver function

- At least 3 weeks from prior systemic treatments including investigational anti-cancer
therapy, radiation therapy; and have recovered from prior toxicities

- Able to swallow capsules

- At least 3 weeks from major surgery

- Agree to practice effective contraception

- Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

- Previously untreated CNS metastases or progressive CNS metastases

- Currently receiving radiotherapy, biological therapy, or any other investigational
agents

- Uncontrolled intercurrent illness including

- Pregnant or lactating women

- Known to be HIV-positive

- A history of active hepatitis B and/or hepatitis C infection