The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Solution, IV, 180 mg/m2, Q14 days, Until PD
Solution, IV, 400 mg/m2, Q14 days, Until PD
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States
Progression free survival based on tumor assessments (CT/MRI)
Time frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Time frame: every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
Time frame: every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
Time frame: weekly
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Solution, IV, 400 mg/m2, Q14 days, Until PD
Solution, IV, 2 mg/kg, Q7 days, Until PD
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Compassionate Cancer Care Medical Group, Inc
Riverside, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Midwest Center For Hematology/Oncology
Joliet, Illinois, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Gurtler, Jayne
Metairie, Louisiana, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States
Pharma Resource
East Providence, Rhode Island, United States
...and 5 more locations