A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer

简要总结

主要结局

次要结局

• Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)(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)
• Overall Survival (OS)(Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011))
• Progression Free Survival (PFS)(Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011))
• Time to Progression(Monthly until death or 7.5 months after last participant was enrolled (up to January 2011))
• Maximum Serum Concentration (Cmax)(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)
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(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)
• Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)(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)
• Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)(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)
• Total and Neutralizing Human Antihuman Antibody (HAHA) Titer(Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles)
• Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)(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)
• 18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)(Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8)
• Carbohydrate Antigen 19-9 (CA 19-9)(At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response)