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

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00521404

Run by

Daiichi Sankyo

People needed

65

Starts

2007-08-15

Expected to finish

2010-08-20

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Myers, Florida, United States
• Study site — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Tucker, Georgia, United States
• Study site — Decatur, Illinois, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Temple, Texas, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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