An Open-Label Phase 2 Trial 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