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