Colon Cancer Clinical Trial
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
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.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
Subjects with measurable or unmeasurable disease
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Men or women at least 18 years of age
Adequate hematologic, renal, hepatic and coagulation function
Exclusion Criteria:
History or known presence of central nervous system (CNS) metastases
Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
Any investigational agent or therapy for advanced or metastatic CRC
Clinically significant cardiac disease
Clinically significant peripheral neuropathy
Active inflammatory bowel disease
Recent gastrointestinal ulcer or hemorrhage
Recent arterial thrombotic event or pulmonary embolus
Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
Recent major surgical procedure or not yet recovered from major surgery
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There are 61 Locations for this study
Hot Springs Arkansas, 71913, United States
Downey California, 90241, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Orange California, 92868, United States
Rancho Mirage California, 92270, United States
San Diego California, 92123, United States
Denver Colorado, 80218, United States
Newark Delaware, 19718, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Kissimmee Florida, 34741, United States
Leesburg Florida, 34788, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Atlanta Georgia, 30309, United States
Lawrenceville Georgia, 30045, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Indianapolis Indiana, 46227, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48106, United States
St. Joseph Michigan, 49085, United States
Rochester Minnesota, 55905, United States
St. Louis Missouri, 63136, United States
Great Falls Montana, 59405, United States
Long Branch New Jersey, 07740, United States
Albuquerque New Mexico, 87109, United States
Bronx New York, 10469, United States
Buffalo New York, 14263, United States
Hudson New York, 12534, United States
New York New York, 10021, United States
Asheville North Carolina, 28801, United States
Burlington North Carolina, 27215, United States
Gastonia North Carolina, 28054, United States
Raleigh North Carolina, 27607, United States
Winston Salem North Carolina, 27103, United States
Cincinnati Ohio, 45226, United States
Columbus Ohio, 43219, United States
Middletown Ohio, 45042, United States
Portland Oregon, 97227, United States
Harrisburg Pennsylvania, 17109, United States
Philadelphia Pennsylvania, 19107, United States
Pottsville Pennsylvania, 17901, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Richardson Texas, 75080, United States
Tyler Texas, 75702, United States
Wichita Falls Texas, 76310, United States
Ogden Utah, 84403, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23235, United States
Tacoma Washington, 98405, United States
Vancouver Washington, 98684, United States
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