Actively Recruiting
ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer
Led by National Cancer Institute, Naples · Updated on 2025-12-17
130
Participants Needed
8
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent for study procedures and correlative studies
- Adults aged 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Diagnosis of metastatic disease
- RAS/BRAF wild-type status at initial diagnosis and in liquid biopsy at study entry
- Candidate for anti-EGFR rechallenge therapy with panitumumab and irinotecan
- Prior anti-EGFR treatment with major response or stable disease for 6 months or more
- Received at least 2 lines of treatment (including allowed prior therapies)
- ECOG Performance Status of 0 or 1 at study entry
- Imaging-documented measurable disease according to RECIST 1.1
- Estimated life expectancy greater than 12 weeks
- Adequate bone marrow function: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL
- Adequate liver function: total bilirubin ≤ 1.5 x ULN or ≤ 2 with biliary stent, AST/ALT ≤ 5 x ULN
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min (males) or ≥ 50 mL/min (females)
- Electrolytes within normal laboratory range (magnesium, calcium, sodium, potassium)
You will not qualify if you...
- History of another malignancy within 5 years, except treated skin cancers or in situ cervical cancer
- Contraindication to panitumumab or irinotecan
- Did not receive immunotherapy if dMMR or MSI-H
- Prior treatment with HDAC inhibitors or valproic acid
- Major surgery within 4 weeks before enrollment
- Pregnant or breastfeeding
- Presence of brain metastases
- Long QT syndrome or QTc interval > 480 msec, or use of QT-prolonging drugs
- Severe or uncontrolled systemic disease or conditions affecting study participation
- Poor cooperation, non-compliance, or inability to understand consent
- Participation in another interventional drug or device study within 30 days before treatment
- Sexually active patients unwilling to practice contraception during and 6 months after study
- History of interstitial pneumonitis or pulmonary fibrosis
- History of corneal perforation or ulcerative keratitis
- Hypersensitivity to valproic acid or excipients
- Acute or chronic hepatitis
- Personal or family history of severe liver disease
- History of hepatic porphyria
- Known coagulation disorders
- Known mitochondrial POLG mutations
- Known urea cycle disorders
AI-Screening
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Trial Site Locations
Total: 8 locations
1
AORN Sant'Anna e San Sebastiano
Caserta, CE, Italy
Actively Recruiting
2
Università degli studi della Campania Luigi Vanvitelli
Naples, Italia, Italy
Actively Recruiting
3
AORN San Giuseppe Moscati Avellino
Avellino, Italy, Italy
Active, Not Recruiting
4
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy, Italy
Not Yet Recruiting
5
Pia Fondazione Di Culto E Religione Card G Panico
Tricase, Lecce, Italy
Not Yet Recruiting
6
Ospedale Civile San Giovanni di Dio
Frattamaggiore, Napoli, Italy
Not Yet Recruiting
7
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Napoli, Italy, 80131
Actively Recruiting
8
Presidio Ospedaliero "Santa Maria delle Grazie"
Pozzuoli, PZ, Italy
Not Yet Recruiting
Research Team
A
Antonio Avallone, MD
CONTACT
A
Alfredo Budillon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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