Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

• Status: Completed
• Trial end date: 2010-08-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Antibodies; Gemcitabine; Immunoglobulins

Criteria

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:

• Anticipation of 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.

• Clinically significant active infection or history of HIV

• Partial or complete bowel obstruction

• Poorly controlled psychiatric illness