To be declared a DLT an adverse experience had a causality related to study therapy. DLTs could be adverse experiences possibly, probably, or definitely related to study therapy by the Investigator, and included the following : Grade 4 neutropenia lasting >= 5 days; Grade 3 or 4 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except inadequately treated diarrhea, nausea and vomiting, rash, hyperglycemia, and transient abnormality of electrolytes. Anemia, infusion reactions, hypersensitivity reactions, and adverse experiences not-related to study therapy did not qualify as DLTs.

Participants treated with study medication. The Dmab 10 mg/kg - Cetux/Irin arm was not evaluated. In the Cetux/Irin - Dmab 10 mg/kg (DDI) arm two participants were not analyzed because one had febrile neutropenia (Grade 3) before the first treatment, and the second had a skin toxicity (Grade 3) before the DLT evaluation period.

Sera were collected from participants prior to administration of the first dose of study drug, every 6 weeks during the study period, then 4 weeks, 8 weeks and 12 weeks post-treatment. A sandwich format enzyme-linked immunosorbent assay (ELISA) was used to detect the presence of HAHA in serum.

All treated participants, excluding those without measurable data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Tmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Ceoi of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Cmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The T1/2 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The CL of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Vss of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-24 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-168 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.

Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Tmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Cmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The T1/2 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The CL of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Vss of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-24 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-168 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Tmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Cmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The T1/2 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29..

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The CL of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Vss of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The AUC0-24 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.

Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

Participants treated with study medication.