Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
NCT ID: NCT00625651
Last Updated: 2014-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
202 participants
INTERVENTIONAL
2007-10-31
2011-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Modified FOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Placebo
Placebo + mFOLFOX6 + Bevacizumab
Placebo
Inactive dummy AMG 655 (to maintain blind)
Modified FOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Modified FOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Interventions
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Placebo
Inactive dummy AMG 655 (to maintain blind)
AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Modified FOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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 D.C., 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
Saint 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
Buffalo, New York, United States
Research Site
Hudson, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, 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
Countries
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References
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Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060464
Identifier Type: -
Identifier Source: org_study_id
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