Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

简要总结

详细描述

The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.

主要结局

次要结局

• Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
• Percentage of Participants With Hematologic Laboratory Test Abnormality(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
• Percentage of Participants With Blood Chemistry Laboratory Test Abnormality(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
• Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4)
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4)
• Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab(0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4)
• Plasma Decay Half-Life (t1/2) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4)
• Maximum Observed Plasma Concentration (Cmax) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
• Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
• Trough Plasma Concentration (Ctrough) of Sunitinib(0.5 hour predose on Day 1 of Cycle 2)
• Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib(24 hours postdose on Day 15 of Cycle 1)
• Number of Participants With Anti-Drug Antibodies (ADA)(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))
• Number of Participants With Objective Response (OR)(Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug))