Could a mood stabilizer help fight colorectal cancer?
NCT ID NCT05694936
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding the drug sodium valproate (commonly used for seizures and mood disorders) to standard targeted therapy (panitumumab or cetuximab) can help control metastatic colorectal cancer longer. The study involves 38 adults with a specific genetic type (RAS wild type) whose cancer has spread and cannot be cured by surgery. Researchers are measuring how long the cancer stays under control and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sodium valproate combined with panitumumab or cetuximab
- What this could lead to
- If successful, this combination could extend the time patients with metastatic colorectal cancer live without their disease worsening.
- What could go wrong
- This is a small, early-phase trial with only 38 participants, so results may not apply broadly. The added drug, valproate, 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
38 people
The number who actually took part.
- Started
-
Jan 2023
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Age ≥ 18 years. 2. Histological diagnosis of colorectal cancer. 3. Metastatic colorectal cancer that is being treated with non-curative intent. This may be because the disease is anatomically not resectable, resection is contra-indicated for any reason, or the patient refuses resection. 4. Measurable disease as assessed by CT scan (by RECIST 1.1). 5. Evidence of RAS wild type status (KRAS exons 2, 3 and 4 and NRAS exons 2, 3, and 4) as assessed by the investigators' choice of testing laboratory. 6. ECOG performance status 0, 1. 7. Suitable, as deemed by the investigator, for maintenance treatment with panitumumab or cetuximab alone or in combination with oral sodium valproate. 8. Completed four months of first-line induction treatment with fluoropyrimidine-based chemotherapy (which may be intravenous or oral, in which case 15 weeks of treatment is required; and either alone or in combination with oxaliplatin or irinotecan) and anti-EGFR monoclonal antibody (panitumumab or cetuximab) without progressive disease. 9. Prior palliative radiotherapy is allowed, provided that (i) no concurrent chemotherapy was administered, (ii) at least 2 weeks after completion of therapy has elapsed before enrolment, and (iii) any toxicities have resolved or are Grade 1. Prior fluoropyrimidine chemotherapy given concurrent with radiation as neoadjuvant treatment for rectal cancer is allowed. 10. Adequate hepatic function with serum total bilirubin \< x1.5 upper limit of normal range and ALT or AST \< x3 upper limit of normal range. 11. Adequate bone marrow function with platelets ≥ 80 X 109/L; neutrophils ≥ 1.5 X 109/L; haemoglobin ≥ 8g/dL. 12. Adequate renal function, with calculated creatinine clearance ≥ 50 mL/min. 13. Any abnormalities in magnesium are not \> Grade 2. Any abnormalities in total calcium are not \> Grade 1. Total calcium should be corrected for albumin level as per the institution's usual calculation method. Serum potassium levels should be above 4.0 mmol/L. 14. Archival formalin-fixed paraffin embedded (FFPE) tumour tissue is available for storage and use by the central laboratory. 15. Life expectancy of at least 12 weeks. 16. Women and partners of women of childbearing potential must agree to use adequate contraception uninterrupted for the duration of receiving VPA, cetuximab and panitumumab, and for an additional 2 months after the last dose of cetuximab and 6 months after the last dose of panitumumab. Adequate contraceptive measures are barrier methods (condoms, diaphragm); oral, injectable, or implant birth control; or abstinence. 17. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 18. Written informed consent including consent for donation of tumour tissue for biomarker studies and collection of peripheral blood for research. Exclusion Criteria: 1. BRAFV600E mutant CRC. 2. CRC with HER2 IHC score of 3+. Note that IHC evaluation for HER2 amplification is required for determining eligibility. HER2 testing using ISH is not required. 3. Prior chemotherapy before first-line induction chemotherapy. Exceptions are adjuvant chemotherapy which was given in association with (i) complete resection of primary colon or rectal cancer provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment, and/or (ii) complete resection of limited colorectal metastases to liver and/or lung provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment. 4. History of life-threatening hypersensitivity reactions to panitumumab or cetuximab, or any product excipients of panitumumab or cetuximab. 5. Known hypersensitivity to sodium valproate. 6. Any other contraindication/s to sodium valproate including mitochondrial disorders and urea cycle disorders. 7. Pre-existing acute or chronic hepatic dysfunction or family history of severe hepatitis 8. Patients with systemic lupus erythematosus are eligible, however the investigator should discuss the potential risk of immune disorders with the participant, which have been noted only exceptionally during the use of VPA. 9. Patients with long QT syndrome, or QTc interval duration \> 480 msec, or use of concomitant medications that significantly prolong the QTc interval. 10. Prior or current treatment with HDAC inhibitor or compounds with HDAC inhibitor-like activity, including hydroxamic acid (e.g vorinostat/zolinza, panobinostat/farydak. Belinostat/beleodaq), benzamide (tucidinostat/epidaza/chidamide), cyclic tetrapeptide (Romidepsin/Istodax) or carboxylic acid (e.g sodium valproate, phenylbutyrate) based HDAC inhibitors. 11. Active treatment with sodium valproate for non-oncological conditions. 12. Active epilepsy or convulsive conditions that require continuous use of anticonvulsants. 13. History of interstitial lung disease or pulmonary fibrosis. 14. Leptomeningeal disease as the only manifestation of malignancy. 15. Untreated/active CNS metastases (i.e., progressing, requiring ongoing corticosteroids or anticonvulsants for symptom control). Patients with CNS metastases are eligible if they have previously been successfully treated with surgery and/or radiotherapy at least 8 weeks prior to cycle 1 day 1, have ceased taking all corticosteroids and/or anticonvulsants for at least 4 weeks and if imaging within 4 weeks of cycle 1 day 1 excludes any progression. 16. Invasive malignant disease, other than CRC, diagnosed within 2 years of randomisation. Patients with non-melanotic skin cancer, carcinoma in situ of the uterine cervix, or any other cancer which was treated with curative intent \> 2 years prior to randomisation and without evidence of relapse, are eligible. 17. Active infection requiring systemic therapy and/or other concurrent uncontrolled medical conditions. 18. Positive pregnancy test prior to the initiation of the study medications. 19. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate. 20. Medical, psychiatric conditions or any other reason that, as assessed by the investigator, may compromise the patient's ability to give informed consent or to comply with the protocol-specified treatments and assessments.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Austin Health
Melbourne, Victoria, 3084, Australia
-
Eastern Health
Box Hill, Victoria, 3128, Australia
-
Grampians Health
Ballarat Central, Victoria, 3350, Australia
-
Peninsula Health
Frankston, Victoria, 3199, Australia
-
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3000, Australia
-
Queen Elizabeth Hospital
Adelaide, South Australia, 5000, Australia
-
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
-
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
-
South West Healthcare
Warrnambool, Victoria, 3280, Australia
-
Southern Adelaide Local Health Network Incorporated
Bedford Park, South Australia, 5042, Australia
-
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010, Australia
-
Western Sydney Local Health District
Westmead, New South Wales, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?