Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Part 1 (Main Study)

• People aged 18 or older of any sex who are willing to give written consent to take part in the study and related tests
• People who have been confirmed through tissue testing to have colorectal cancer (a type of bowel cancer) that has spread to other parts of the body
• People whose cancer has specific gene characteristics — no changes (mutations) in genes called RAS and BRAF — confirmed both at initial diagnosis and through a blood test at the start of the study
• People whose cancer previously responded well to a type of targeted therapy called anti-EGFR treatment (meaning the cancer shrank or stayed stable for at least 6 months), who then received further treatment after the cancer grew again, and whose doctors consider them suitable candidates for a repeat course of anti-EGFR therapy using panitumumab and irinotecan
• People who have received at least 2 prior lines of cancer treatment (previous treatment with certain other medicines such as regorafenib or trifluridine/tipiracil is allowed, but a previous repeat course of anti-EGFR therapy is not allowed)
• People who are well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG score of 0 or 1)
• People who have measurable disease visible on scans
• People with an estimated life expectancy of more than 12 weeks
• People whose blood counts, liver function, kidney function, and electrolyte levels (e.g. magnesium, calcium, sodium, potassium) are within acceptable ranges as measured by blood tests

Part 2 (Second Phase — applies only to some Part 1 participants)

• People who took part in Part 1 of this study and were assigned to the control treatment group, and whose cancer has since progressed on that treatment
• People who still meet the fitness, scan, life expectancy, and blood test requirements listed above for Part 1

Who may not be able to join:

Part 1

• People who have had another cancer within the past five years (exceptions may apply for certain skin cancers or early-stage cervical cancer that has been treated — confirm with trial site)
• People for whom the medicines panitumumab or irinotecan are medically unsuitable for any reason
• People with a type of bowel cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) who have not previously received immunotherapy
• People who have previously been treated with a type of drug called an HDAC inhibitor, or medicines with similar effects (such as valproic acid, a medicine sometimes used for epilepsy or mood disorders)
• People who have had major surgery within 4 weeks before joining the study
• People who are pregnant or breastfeeding
• People who have cancer that has spread to the brain
• People with a heart condition involving a prolonged QT interval (an electrical timing issue in the heart), or who are taking medicines known to affect heart rhythm in this way
• People with serious or uncontrolled illness, or any other condition that the study doctor believes would make participation unsafe or affect the study results
• People with a history of difficulty cooperating with medical treatment or understanding medical information, or any condition that may affect their ability to understand the consent form
• People who have taken part in another clinical drug or medical device study within 30 days before starting treatment
• Sexually active people of childbearing potential who are not willing to use contraception during the study and for 6 months after the last treatment
• People with a history of a lung condition called interstitial pneumonitis or pulmonary fibrosis
• People with a history of corneal perforation, ulceration, or a serious eye condition called keratitis
• People who are allergic to valproic acid or any of its ingredients
• People with active hepatitis (acute or chronic liver inflammation)
• People with a personal or family history of severe liver disease
• People with a history of a liver condition called hepatic porphyria
• People with known blood clotting disorders
• People with a known genetic condition affecting a specific gene called POLG (for example, Alpers-Huttenlocher Syndrome)
• People with known urea cycle disorders (rare inherited conditions affecting how the body processes protein)

Part 2

• People who did not receive further cancer treatment after their cancer progressed in Part 1
• People who have cancer that has spread to the brain
• People who are pregnant or breastfeeding
• People who had serious side effects from panitumumab or irinotecan during Part 1 that caused those treatments to be stopped
• People with heart rhythm concerns (prolonged QT interval) or who are taking medicines that affect heart rhythm in this way
• People with serious or uncontrolled illness or any condition the study doctor considers unsafe
• Sexually active people of childbearing potential who are not willing to use contraception during the study and for 6 months after the last treatment

Important: Always verify eligibility with the trial site directly before applying.