This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Almac Clinical Technologies
San Francisco, California, United States
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
Time frame: up to 4 years
Response rate (complete response + partial response)
Time frame: up to 4 years
Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death
Time frame: up to 4 years
Overall survival
Time frame: up to 4 years
Safety: Incidence of adverse events
Time frame: up to 4 years
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Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States
Florida Hospital Cancer Inst
Orlando, Florida, United States
Georgia Cancer Specialists - Northside
Atlanta, Georgia, United States
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
Ingalls Memorial Hospital; Cancer Research Center
Harvey, Illinois, United States
Baptist Hospital East
Louisville, Kentucky, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
...and 13 more locations