A Phase II III Study of MK0646 Treatment in Combination With Cetuximab and Irinotecan For Patients With Metastatic Colorectal Cancer
Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the insulin-like growth
factor type 1 receptor-1 (IGF-1R).
Dalotuzumab may act through:
Inhibition of insulin-like growth factor-1 (IGF-1)-mediated cell signaling to cause
reductions in tumor growth and spread Antibody dependent cell-mediated cytotoxicity
In preclinical studies, dalotuzumab improved the activity of an anti-epidermal growth factor
receptor (EGFR) mAb and the activity of Erlotinib, a small molecule inhibitor of EGFR.
All eligible participants will receive cetuximab 400 mg/m2 infusion over 120 minutes
followed by weekly infusions of 250 mg/m2 over 60-120 minutes along with irinotecan infusion
over 30-90 minutes. Dosage of irinotecan will be the same as most recent pre-study therapy.
Participants will then be assigned to one of 3 treatment arms.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Every three months
United States: Food and Drug Administration