Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer

A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).

A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.

Inclusion Criteria:

• Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens
• Must have measurable disease according to RECIST
• Eastern Cooperative Oncology Group performance status 0-1
• Adequate bone marrow, hepatic and renal function
• Ability to swallow capsules
• 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

Exclusion Criteria:

• Non-small cell cancer histology contains a component of small cell lung cancer
• Previously untreated CNS metastasis or progressive CNS metastasis
• Prior treatment with a CDK inhibitor
• Currently receiving radiotherapy, biological therapy, or any other investigational therapy
• Uncontrolled intercurrent illness
• Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer
• Pregnant or lactating women
• Known to be HIV-positive
• Active hepatitis B and/or hepatitis C infection