Metastatic Colorectal Cancer Clinical Trial
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
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%.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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