FDA Hold May 2007

This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

INCLUSION CRITERIA:

• Men or women age 18 years or older

• Histologically or cytologically confirmed NSCLC

  • Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
  • Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion

• Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC

• Measurable disease on computerized tomography (CT) scan

• ECOG Performance Status of 0 or 1

• Expected survival ≥12 weeks

• Provide written informed consent

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.