Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).

Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).

AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).

Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.

Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.

Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.

Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).

Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.

Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).

Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.

Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).

Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.

Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.

AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.

AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).

AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).

PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).

Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.

ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.

Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.

Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.

Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.

Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.