ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorec… (NCT06714357) | Clinical Trial Compass
RecruitingPhase 2
ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer
Italy130 participantsStarted 2025-03-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent to study procedures and to correlative studies.
✓. Either sex aged ≥ 18.
✓. Histologically proven of colorectal adenocarcinoma.
✓. Diagnosis of metastatic disease.
✓. RAS/BRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR/MSI status
✓. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing).
✓. Patient candidate to anti-EGFR rechallenge therapy with panitumumab and irinotecan as clinical practice; 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.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.
Exclusion criteria
✕. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
✕. Any contraindication to panitumumab or irinotecan.
✕. Not received immunotherapy if dMMR or MSI-H.
What they're measuring
1
Study Part 1 - Progression Free Survival rate at 16 weeks in the two arms.
. 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.
✕. Major surgical intervention within 4 weeks prior to enrollment.
✕. Pregnancy and breast-feeding.
✕. Any brain metastasis.
✕. Patients with long QT-syndrome or QTc interval duration \> 480 msec or concomitant medication with drugs prolonging QTc .