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Spots Global Cancer Trial Database for QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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