drugset / Trial / NCT00940758

Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy

NCT00940758

Phase 1 Completed 18 enrolled PharmaEngine
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.

Timeline

Start
2009-06
Primary completion
2012-05
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Sucrosofate Other / unclassified 50 mg/m2
Subject Irinotecan Sucrosofate Other / unclassified 100 mg/m2

Indications