Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

Time frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)

Population: Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.

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

Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1

Population: 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).

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.

Time frame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4

Population: 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.

Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4

Population: 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.

Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1

Population: 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.

Time frame: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)

Population: 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.

Time frame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)

Population: 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).

Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

Population: 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.

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).

Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

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

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).

Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

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

Time frame: 24 hours postdose on Day 15 of Cycle 1

Population: 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).

Time frame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4

Population: 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.

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

Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4

Population: 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.

Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1

Population: 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).

Time frame: 0.5 hour predose on Day 1 of Cycle 2

Population: 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).