Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Exclusion Criteria

• •More than 2 prior chemotherapy regimens
• •Clinically significant laboratory abnormalities, specifically:
• •* Total bilirubin ≥ institutional upper limit of normal (ULN)
• •* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN
• •* Serum creatinine ≥2.0mg/dL
• •* Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
• •Untreated or symptomatic brain metastases
• •Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
• •A history of severe hypersensitivity to drugs formulated with polysorbate 80
• •Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
• •Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
• •Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.