A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Inclusion Criteria:

Histologically or cytologically confirmed recurrent NSCLC
Age of 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Measurable disease according to RECIST
Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
Adequate bone marrow function
Adequate renal function
Adequate liver function
At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
At least 3 weeks from major surgery
Patient must be able to swallow capsules
Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

NSCLC histology contains a component of small cell lung cancer
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 including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
Pregnant or lactating women
Known to be HIV-positive