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

• progression-free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
• duration of response [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
• duration of stable disease [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
• overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).

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