The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants with metastatic Kirsten Rat Sarcoma (K-RAS) wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance
180 mg/m² every 14 days until disease progression or participant intolerance
IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance
ImClone Investigational Site
Vallejo, California, United States
ImClone Investigational Site
Greenville, North Carolina, United States
ImClone Investigational Site
Scranton, Pennsylvania, United States
Progression-Free Survival (PFS) Rate at 18 Weeks
Time frame: Approximately 18 Weeks
Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]
Time frame: Randomization up to 26.3 months
Overall Survival (OS)
Time frame: Randomization up to 26.3 months
Progression Free Survival (PFS) Over Entire Duration
Time frame: Randomization up to 26.3 months
The Number of Participants Who Had a Complete Resection/Ablation of Metastases With no Evidence of Disease Remaining (Resection Rate)
Time frame: Randomization up to 26.3 months
Toxicity of the Irinotecan + Cetuximab + IMC-A12 Regimen
Time frame: Randomization up to 26.3 months
Post-treatment Serum Levels of IMC-A12 in Participants Receiving IMC-A12
Time frame: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks
Change in Behavioral and Health Outcomes [BAHO] Quality of Life (QoL) Questionnaire
Time frame: Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)
Serum Anti-IMC-A12 Antibody Assessment
Time frame: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks
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