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

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

A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.

The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.

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