Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
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
1 other identifier
interventional
202
1 country
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2007
Longer than P75 for phase_1
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 25, 2014
March 1, 2014
2.8 years
February 14, 2008
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Length of study
Secondary Outcomes (6)
Objective response rate
Length of study
Duration of response
Length of study
Time-to-response
Length of study
Overall survival
Length of study
AMG 655 pharmacokinetic parameters
Length of study
- +1 more secondary outcomes
Study Arms (3)
AMG 655 Low Dose
EXPERIMENTALAMG 655 (low dose) + mFOLFOX6 + Bevacizumab
Placebo
PLACEBO COMPARATORPlacebo + mFOLFOX6 + Bevacizumab
AMG 655 High Dose
EXPERIMENTALAMG 655 (high dose) + mFOLFOX6 + Bevacizumab
Interventions
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
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 will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (61)
Research Site
Hot Springs, Arkansas, 71913, United States
Research Site
Downey, California, 90241, United States
Research Site
La Jolla, California, 92093-0957, United States
Research Site
Loma Linda, California, 92354, United States
Research Site
Orange, California, 92868, United States
Research Site
Rancho Mirage, California, 92270, United States
Research Site
San Diego, California, 92123, United States
Research Site
Denver, Colorado, 80218, United States
Research Site
Newark, Delaware, 19718, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Boca Raton, Florida, 33486, United States
Research Site
Kissimmee, Florida, 34741, United States
Research Site
Leesburg, Florida, 34788, United States
Research Site
Miami, Florida, 33136, United States
Research Site
Miami, Florida, 33176, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Lawrenceville, Georgia, 30045, United States
Research Site
Harvey, Illinois, 60426, United States
Research Site
Maywood, Illinois, 60153, United States
Research Site
Indianapolis, Indiana, 46227, United States
Research Site
Overland Park, Kansas, 66210, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Baltimore, Maryland, 21215, United States
Research Site
Baltimore, Maryland, 21237, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Ann Arbor, Michigan, 48106-0995, United States
Research Site
Saint Joseph, Michigan, 49085, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
St Louis, Missouri, 63136, United States
Research Site
Great Falls, Montana, 59405, United States
Research Site
Long Branch, New Jersey, 07740, United States
Research Site
Albuquerque, New Mexico, 87109-4397, United States
Research Site
Buffalo, New York, 14263, United States
Research Site
Hudson, New York, 12534, United States
Research Site
New York, New York, 10021, United States
Research Site
The Bronx, New York, 10469, United States
Research Site
Asheville, North Carolina, 28801, United States
Research Site
Burlington, North Carolina, 27215, United States
Research Site
Gastonia, North Carolina, 28054, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Cincinnati, Ohio, 45226, United States
Research Site
Columbus, Ohio, 43219, United States
Research Site
Middletown, Ohio, 45042, United States
Research Site
Portland, Oregon, 97227, United States
Research Site
Harrisburg, Pennsylvania, 17109, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Pottsville, Pennsylvania, 17901, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
Memphis, Tennessee, 38120, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Austin, Texas, 78731, United States
Research Site
Richardson, Texas, 75080, United States
Research Site
Tyler, Texas, 75702, United States
Research Site
Wichita Falls, Texas, 76310, United States
Research Site
Ogden, Utah, 84403, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Norfolk, Virginia, 23502, United States
Research Site
Richmond, Virginia, 23235, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Vancouver, Washington, 98684, United States
Related Publications (1)
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.
PMID: 24122767BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 28, 2008
Study Start
October 1, 2007
Primary Completion
August 1, 2010
Study Completion
September 1, 2011
Last Updated
April 25, 2014
Record last verified: 2014-03