Effect of Panitumumab on the Pharmacokinetics of Irinotecan
Study Details
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
Protocol Summary
Maximum observed plasma concentration (Cmax) of irinotecan
Timeframe: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).
Area under the plasma concentration-time curve from the time of dosing to infinity (AUCinf) for irinotecan
Timeframe: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).
Area under the plasma concentration-time curve from the time of the last quantifiable concentration (AUClast) for irinotecan
Timeframe: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).
Number of Participants with Clinically Significant Adverse Events (AEs)
Timeframe: The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months.