Can a mood stabilizer help fight colorectal cancer?
NCT ID NCT06714357
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding valproic acid (a drug used for epilepsy) to a repeat course of anti-EGFR therapy (irinotecan and panitumumab) can improve outcomes for people with a specific type of metastatic colorectal cancer (RAS/BRAF wild-type). The study will enroll 130 participants whose cancer has progressed after prior treatment. The main goal is to see if the combination delays cancer growth for at least 16 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- valproic acid combined with irinotecan and panitumumab
- What this could lead to
- If it works, this could offer a new treatment option for people with metastatic colorectal cancer whose tumors have stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial (130 people) and the combination may not improve outcomes. Valproic acid can cause side effects like drowsiness and liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (Study Part 1): 1. Written informed consent to study procedures and to correlative studies. 2. Either sex aged ≥ 18. 3. Histologically proven of colorectal adenocarcinoma. 4. Diagnosis of metastatic disease. 5. 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 6. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing). 7. 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. a. Note. Patients must have received at least 2 lines of treatment. Previous treatment with regorafenib, trifluridine/tipiracile, trifluridine/tipiracile + bevacizumab or fruquintinib is allowed. Previous rechallenge with anti-EGFR MoAb is NOT allowed. Adjuvant treatment will be considered as one line of therapy in case of progression within 6 months from the last dose of treatment. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry. 9. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 10. Estimated life expectancy of more than 12 weeks 11. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL. 12. 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. 13. 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). 14. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range. Exclusion Criteria (Study Part 1): 1. 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. 2. Any contraindication to panitumumab or irinotecan. 3. Not received immunotherapy if dMMR or MSI-H. 4. 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. 5. Major surgical intervention within 4 weeks prior to enrollment. 6. Pregnancy and breast-feeding. 7. Any brain metastasis. 8. Patients with long QT-syndrome or QTc interval duration \> 480 msec or concomitant medication with drugs prolonging QTc . 9. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study. 10. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form. 11. Participation in any interventional drug or medical device study within 30 days prior to treatment start. 12. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment. 13. History of interstitial pneumonitis or pulmonary fibrosis. 14. History of corneal perforation or ulceration keratitis. 15. Hypersensitivity to valproic acid or any of listed excipients. 16. Acute hepatitis or chronic hepatitis. 17. Personal or familial anamnesis of severe hepatopathy. 18. History of Hepatic porphyria 19. Known coagulation disorders. 20. Known Polymerase-gamma (POLG) mitochondrial mutation (e.g. Alpers-Huttenlocher Syndrome). 21. Known urea cycle disorders. * Inclusion Criteria (Study Part 2): 1\. Have provided written informed consent to study procedures and to correlative studies. 2\. Enrolled in VICTORIA - Study Part 1 and randomized to ARM A (control arm) 3. Progressed to treatment within ARM A (control arm). 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry. 5\. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 6. Estimated life expectancy of more than 12 weeks. 7. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL. 8. 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. 9. 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). 10. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range. -Exclusion Criteria (Study Part 2): 1. Did not receive a subsequent line of therapy upon progression to ARM A. 2. Any brain metastasis. 3. Pregnancy and breast-feeding. 4. Serious Adverse events with panitumumab or irinotecan, leading to treatment interruption and discontinuation. 5. Patients with long QT-syndrome or QTc interval duration \> 480 msec or concomitant medication with drugs prolonging QTc 6. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study. 7. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AORN San Giuseppe Moscati Avellino
ACTIVE_NOT_RECRUITINGAvellino, Italy, Italy
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AORN Sant'Anna e San Sebastiano
RECRUITINGCaserta, CE, Italy
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Azienda Sanitaria Universitaria Friuli Centrale
NOT_YET_RECRUITINGUdine, Italy, Italy
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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITINGNaples, Napoli, 80131, Italy
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Ospedale Civile San Giovanni di Dio
NOT_YET_RECRUITINGFrattamaggiore, Napoli, Italy
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Pia Fondazione Di Culto E Religione Card G Panico
NOT_YET_RECRUITINGTricase, Lecce, Italy
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Presidio Ospedaliero "Santa Maria delle Grazie"
NOT_YET_RECRUITINGPozzuoli, PZ, Italy
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Università degli studi della Campania Luigi Vanvitelli
RECRUITINGNaples, Italia, Italy
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