Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.

Time frame: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

Population: Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.

Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.

Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Levels of HAHA in serum were detected at baseline.

Time frame: Baseline (Day 1 of Cycle 1)

Population: All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.

Levels of HAHA in serum were detected at the last follow-up visit.

Time frame: The last follow-up visit (150 days post last dose)

Population: All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.

Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an X in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block.

Time frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Population: The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.

Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations

Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.

Time frame: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)

Population: Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.

The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.

Time frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Population: The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.

Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.

Time frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

Population: Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.

Time frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

Population: Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.