FDA Hold May 2007

The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.

Inclusion Criteria:

• Men or women age ≥18 years
• Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
• Measurable disease defined per RECIST
• Karnofsky Performance Status ≥50
• Expected survival ≥12 weeks
• Provide written informed consent

Exclusion Criteria:

• CNS metastases
• Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
• Radiation therapy to >25% of the bone marrow
• Clinically significant laboratory abnormalities
• 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
• The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
• 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 radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
• Pregnancy or lactation