OncoMatch/Clinical Trials/NCT06714357
ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer
Is NCT06714357 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including irinotecan and panitumumab for colorectal cancer metastatic.
Treatment: irinotecan · panitumumab · Valproic Acid (VPA) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS/BRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA
Required: NRAS wild-type
RAS/BRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA
Required: BRAF wild-type
RAS/BRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA
Required: KRAS wild-type
RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing)
Required: NRAS wild-type
RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing)
Required: BRAF wild-type
RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing)
Required: MMR status known
known MMR/MSI status
Disease stage
Metastatic disease required
Diagnosis of metastatic disease. Imaging-documented measurable disease, according to RECIST 1.1 criteria.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-EGFR monoclonal antibody (panitumumab)
Efficacy of anti-EGFR drug in any line of treatment with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or stable disease ≥ 6 months and received a subsequent line of therapy upon progression
Cannot have received: HDAC inhibitor (valproic acid)
Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid
Cannot have received: anti-EGFR monoclonal antibody rechallenge
Previous rechallenge with anti-EGFR MoAb is NOT allowed
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L and hemoglobin ≥ 9 g/dL
Kidney function
serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula)
Liver function
total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN
Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L and hemoglobin ≥ 9 g/dL. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula). Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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