Open-label Study of CS1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Primary Objective:

- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival rate at 16 weeks.

Secondary Objectives:

• To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response and overall survival.
• To determine the pharmacokinetics of C-1008 and gemcitabine
• To study potential biomarkers of CS-1008 activity
• To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.

• Drug: CS-1008 (humanized anti-DR5 antibody)
  CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
  Other Name: CS1008
• Drug: gemcitabine
  Gemcitabine - 1000mg/meter sq
  Other Name: Gemzar

Inclusion Criteria:

• Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older

Exclusion Criteria:

• No anticipated need for major surgery or radiation therapy during the study
• Heart Disease exclusions:myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
• No clinically significant active infection or history of HIV
• No partial or complete bowel obstruction
• Cannot have poorly controlled psychiatric illness