Panitumumab DDI Irinotecan
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan. The hypothesis is panitumumab does not affect the PK of irinotecan. This will be concluded if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC for irinotecan with and without concomitant panitumumab administration fall inside the interval of 70-143%.
Metastatic Colorectal Cancer
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-label Study to Determine the Effect of Panitumumab on the Pharmacokinetics of Irinotecan in Subjects With Unresectable Metastatic Colorectal Cancer|
|Study Start Date:||January 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
This is a single arm PK study of panitumumab and irinotecan.
The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
Other Name: VectibixDrug: Irinotecan
The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
Other Name: Camptosar
|United States, Montana|
|Billings, Montana, United States|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada|
|Toronto, Ontario, Canada|