drugset / Trial / NCT06714357

ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer

NCT06714357

Phase 2 Recruiting 130 enrolled National Cancer Institute, Naples
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.

Timeline

Start
2025-03-12
Primary completion
2026-12-20
Completion
2027-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule 500 mg Oral
Background Irinotecan Small molecule 180 mg/m2
Background Panitumumab Monoclonal antibody 6 mg/kg Intravenous

Indications