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Brief Title: Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Official Title: 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
Study ID: NCT00521404
Brief 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.
Detailed Description: 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 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 BIP CS-1008 and DSC CS-1008. * To study potential biomarkers of CS-1008 activity * To assess possible human anti-human antibody formation after exposure to CS-1008 * To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Washington, District of Columbia, United States
, Fort Myers, Florida, United States
, Atlanta, Georgia, United States
Georgia Cancer Specialists, Tucker, Georgia, United States
, Decatur, Illinois, United States
, Minneapolis, Minnesota, United States
, Cincinnati, Ohio, United States
, Chattanooga, Tennessee, United States
, Nashville, Tennessee, United States
, Temple, Texas, United States
, Richmond, Virginia, United States
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR