drugset
drugset / Trial / NCT01605344

Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI

NCT01605344 ↗

Phase 1 Withdrawn UNC Lineberger Comprehensive Cancer Center
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination with atorvastatin.

Timeline

Start
2012-04
Primary completion
2013-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg Oral
Subject Irinotecan Small molecule — Other
Background Leucovorin Small molecule — Other
Background fluorouracil Small molecule — Other

Indications

colorectal adenocarcinoma