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Brief Title: Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Official Title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Study ID: NCT00327327
Brief Summary: AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Clinical Research Center, Tucson, Arizona, United States
US Oncology Orlando, Cancer Centers of FL, Ocoee, Florida, United States
US Oncology Indiana, Indianapolis, Indiana, United States
Univ of Michigan, Ann Arbor, Michigan, United States
US Oncology Albany, New York Oncology, Albany, New York, United States
US Oncology Kettering, Kettering, Ohio, United States
Fox Chase Cancer Ctr., Philadelphia, Pennsylvania, United States
US Oncology, Virginia Oncology Assoc, Norfolk, Virginia, United States
US Oncology Northwest, Northwest Cancer Specialists, Vancouver, Washington, United States
Name: Mark Zalupski, MD
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Cohen, MD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR