At a glance
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A Phase I Study of MK-0646 in Combination With Cetuximab and Irinotecan in Patients With Advanced or Metastatic Colorectal Cancer
In Brief
A Phase 1 clinical trial evaluating Dalotuzumab 10 mg/kg, Cetuximab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 20 participants.
Detailed Summary
The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.
Study Details
Timeline
Interventions
Dalotuzumab at 10 mg/kg was intravenously administered once weekly
Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2
Irinotecan was administered with an intravenous infusion of 150 mg/m\^2, once every other week for 42 days
Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg