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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

202

Study ID:

NCT00625651

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 61 Locations for this study

See Locations Near You

Research Site
Hot Springs Arkansas, 71913, United States
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Downey California, 90241, United States
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La Jolla California, 92093, United States
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Loma Linda California, 92354, United States
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Orange California, 92868, United States
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Rancho Mirage California, 92270, United States
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San Diego California, 92123, United States
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Denver Colorado, 80218, United States
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Newark Delaware, 19718, United States
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Washington District of Columbia, 20007, United States
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Boca Raton Florida, 33486, United States
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Kissimmee Florida, 34741, United States
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Leesburg Florida, 34788, United States
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Miami Florida, 33136, United States
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Miami Florida, 33176, United States
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Atlanta Georgia, 30309, United States
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Lawrenceville Georgia, 30045, United States
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Harvey Illinois, 60426, United States
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Maywood Illinois, 60153, United States
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Indianapolis Indiana, 46227, United States
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Overland Park Kansas, 66210, United States
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Louisville Kentucky, 40202, United States
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Baltimore Maryland, 21215, United States
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Baltimore Maryland, 21237, United States
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Boston Massachusetts, 02115, United States
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Ann Arbor Michigan, 48106, United States
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St. Joseph Michigan, 49085, United States
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Rochester Minnesota, 55905, United States
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St. Louis Missouri, 63136, United States
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Great Falls Montana, 59405, United States
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Long Branch New Jersey, 07740, United States
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Albuquerque New Mexico, 87109, United States
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Bronx New York, 10469, United States
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Buffalo New York, 14263, United States
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Hudson New York, 12534, United States
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New York New York, 10021, United States
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Asheville North Carolina, 28801, United States
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Burlington North Carolina, 27215, United States
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Gastonia North Carolina, 28054, United States
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Raleigh North Carolina, 27607, United States
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Winston Salem North Carolina, 27103, United States
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Cincinnati Ohio, 45226, United States
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Columbus Ohio, 43219, United States
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Middletown Ohio, 45042, United States
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Portland Oregon, 97227, United States
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Harrisburg Pennsylvania, 17109, United States
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Philadelphia Pennsylvania, 19107, United States
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Pottsville Pennsylvania, 17901, United States
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Greenville South Carolina, 29605, United States
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Memphis Tennessee, 38120, United States
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Nashville Tennessee, 37203, United States
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Austin Texas, 78731, United States
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Richardson Texas, 75080, United States
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Tyler Texas, 75702, United States
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Wichita Falls Texas, 76310, United States
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Ogden Utah, 84403, United States
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Fairfax Virginia, 22031, United States
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Norfolk Virginia, 23502, United States
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Richmond Virginia, 23235, United States
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Tacoma Washington, 98405, United States
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Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

202

Study ID:

NCT00625651

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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