drugset / Trial / NCT04034173

Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

NCT04034173 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The present hypothesis is that anti-EGFR agents are active in tumors with low-level RAS mutation when the majority of tumor cells is still sensitive. While response rate may be high and may reflect sensitivity to anti-EGFR agents, PFS is anticipated to be shorter than in RAS wild-type patients due to the faster development of resistance when sensitive cells are eradicated and when the RAS-mutant anti-EGFR resistant clones become predominant. The characteristics of low-level RAS mutant tumors would be: * Objective response rate (ORR) high (reflecting the sensitive clone) * Progression-free survival (PFS) short (reflecting the more rapid outgrowth of RAS mutant clones)

Timeline

Start
2019-08-01
Primary completion
2024-08-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous