A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature \>38.5 degrees Celsius (C) or 3 oral temperatures \>38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia).

Time frame: Baseline up to Cycle 1 / Day 28

Population: Safety population: all participants who received any study treatment. Cubic millimeters (mm\^3).

FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.

Time frame: Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.

Time frame: Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.

Time frame: At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.

Time frame: Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.

Time frame: Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.

Time frame: Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

Time frame: Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.

Time frame: Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)

Population: Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Time frame: At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response

Population: Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.

PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.

Time frame: Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)

Population: Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.

Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.

Time frame: Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

HAHA assessed as an indicator of immunogenicity to CP-870893.

Time frame: Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles

Population: No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.

Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.

Time frame: Baseline up to time of determination of maximum tolerated dose (MTD)

Population: Safety population