A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Incurable advanced solid tumors that did not respond to conventional therapy or for
which no effective therapy exists

- Age >=18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 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

Exclusion Criteria:

- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI
scan performed at 4 weeks or longer after the last treatment for CNS metastasis

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

- Uncontrolled intercurrent illness

- Pregnant or lactating women

- Known to be HIV-positive

- Known active hepatitis B and/or hepatitis C infection