Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer
Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
Locations
United States
Alabama
Birmingham
Washington, D.c.
Washington
Florida
Fort Myers
Georgia
Atlanta
Georgia Cancer Specialists
Tucker
Illinois
Decatur
Minnesota
Minneapolis
Ohio
Cincinnati
Tennessee
Chattanooga
Nashville
Texas
Temple
Virginia
Richmond
Time Frame
Start Date: 2007-08-15
Completion Date: 2010-08-20
Participants
Target number of participants: 65
Treatments
Experimental: CS-1008 + gemcitabine
CS-1008 + gemcitabine
Authors
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo