Spots Global Cancer Trial Database for Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Official Title: A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
Study ID: NCT00625651
Study Description
Brief Summary: This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC). The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Hot Springs, Arkansas, United States
Research Site, Downey, California, United States
Research Site, La Jolla, California, United States
Research Site, Loma Linda, California, United States
Research Site, Orange, California, United States
Research Site, Rancho Mirage, California, United States
Research Site, San Diego, California, United States
Research Site, Denver, Colorado, United States
Research Site, Newark, Delaware, United States
Research Site, Washington, District of Columbia, United States
Research Site, Boca Raton, Florida, United States
Research Site, Kissimmee, Florida, United States
Research Site, Leesburg, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Lawrenceville, Georgia, United States
Research Site, Harvey, Illinois, United States
Research Site, Maywood, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Overland Park, Kansas, United States
Research Site, Louisville, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, St. Joseph, Michigan, United States
Research Site, Rochester, Minnesota, United States
Research Site, St. Louis, Missouri, United States
Research Site, Great Falls, Montana, United States
Research Site, Long Branch, New Jersey, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Bronx, New York, United States
Research Site, Buffalo, New York, United States
Research Site, Hudson, New York, United States
Research Site, New York, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, Burlington, North Carolina, United States
Research Site, Gastonia, North Carolina, United States
Research Site, Raleigh, North Carolina, United States
Research Site, Winston Salem, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Middletown, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Harrisburg, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pottsville, Pennsylvania, United States
Research Site, Greenville, South Carolina, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Austin, Texas, United States
Research Site, Richardson, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Wichita Falls, Texas, United States
Research Site, Ogden, Utah, United States
Research Site, Fairfax, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Richmond, Virginia, United States
Research Site, Tacoma, Washington, United States
Research Site, Vancouver, Washington, United States
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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