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Brief Title: QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
Official Title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer
Study ID: NCT00630552
Brief Summary: This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Alhambra, California, United States
Research Site, Bakersfield, California, United States
Research Site, Fullerton, California, United States
Research Site, La Jolla, California, United States
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Northridge, California, United States
Research Site, Oxnard, California, United States
Research Site, Rancho Mirage, California, United States
Research Site, Redondo Beach, California, United States
Research Site, San Francisco, California, United States
Research Site, Santa Maria, California, United States
Research Site, Santa Monica, California, United States
Research Site, Miami, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Atlanta, Georgia, United States
Research Site, Marietta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Harvey, Illinois, United States
Research Site, Baltimore, Maryland, United States
Research Site, Westminster, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Henderson, Nevada, United States
Research Site, Albany, New York, United States
Research Site, New York, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Hickory, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Eugene, Oregon, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Providence, Rhode Island, United States
Research Site, Greenville, South Carolina, United States
Research Site, Austin, Texas, United States
Research Site, Austin, Texas, United States
Research Site, Austin, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Round Rock, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Tacoma, Washington, United States
Research Site, Yakima, Washington, United States
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR