Phase 2 Stomach 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:

• People aged 18 or older.
• People who have been diagnosed with a well-differentiated lung or digestive/hormonal system neuroendocrine tumour (a specific type of slow-to-moderate growing tumour, classified as NET G1, G2, or G3) that has continued to grow after at least one previous treatment such as hormone-blocking injections, targeted therapy, chemotherapy, or a specific radiation treatment called PRRT.
• People who have been diagnosed with a type of faster-growing neuroendocrine tumour called Large Cell Neuroendocrine Carcinoma, where a specific tumour activity marker (Ki67) is below 55%, and whose cancer has continued to grow after platinum-based chemotherapy.
• People whose cancer has been shown to be growing on a scan (CT or MRI) within the 12 months before joining the trial.
• People who have at least one tumour that can be measured on a scan according to standard medical criteria (called RECIST 1.1).
• People who are able to swallow tablets or capsules.
• People whose tumour either does or does not cause hormone-related symptoms.
• People who are already taking somatostatin analogue injections, provided the dose has been stable for at least two months.
• People who have waited at least 4 weeks since finishing a previous targeted cancer therapy.
• People who have waited at least 6 months since finishing PRRT treatment.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
• People whose blood counts, liver function, and kidney function meet specific minimum levels as determined by blood tests (confirm with trial site for exact values).
• People who have recovered from side effects of any previous cancer treatments.
• People with an estimated life expectancy of at least 12 weeks.
• Women who could become pregnant must agree to use effective contraception during the trial and for 4 months after the last dose of the trial treatment.
• Men who are fertile must agree to use effective contraception during the trial and for 6 months after the last dose.
• Women who could become pregnant must have a negative pregnancy blood test within 14 days before starting the trial treatment.
• People who are willing and able to give written consent to participate and to follow the trial requirements.

Who may not be able to join:

• People who have received any anticancer treatment within 4 weeks before joining.
• People who have previously been treated with either of the two drugs used in this trial: temozolomide or cabozantinib.
• People who have had radiation therapy to a bone spread within the past 2 weeks, or any other external radiation within the past 4 weeks.
• People who have received a type of radioactive treatment (PRRT or similar radionuclide therapy) within the past 6 months.
• People who are still experiencing significant ongoing health problems caused by previous radiation therapy or surgery.
• People who have cancer that has spread to the brain or the area around the brain, unless it has been treated and has been stable for at least 3 months.
• People taking blood-thinning medications (anticoagulants) or anti-platelet drugs at treatment doses.
• People with a chronic hepatitis B infection, whether currently active or not.
• People on long-term steroid or immune-suppressing medications.
• People with certain serious stomach or bowel conditions, such as inflammatory bowel disease, active stomach ulcers, recent bowel blockage or perforation, or abdominal abscess within the past 6 months (confirm full list with trial site).
• People with certain lung conditions, such as cavities forming in lung tissue or disease blocking the airways.
• People with tumours that are growing into major blood vessels such as the main lung artery or the aorta (confirm with trial site).
• People who have had significant bleeding episodes — such as blood in urine, vomiting blood, or coughing up blood — within the past 3 months.
• People with certain other serious health conditions, including active infections needing treatment, HIV or AIDS, serious non-healing wounds, a condition causing poor nutrient absorption, uncontrolled underactive thyroid, need for dialysis, or a history of organ transplantation.
• People with poorly controlled heart failure (confirm severity grading with trial site).
• People with a heart pumping function measured at 40% or below.
• People with a specific type of heart electrical abnormality on an ECG (QTcF above 470ms for women or above 450ms for men), or a condition called congenital long QT syndrome.
• People with rare inherited conditions affecting how the body processes certain sugars, such as galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption.
• People who have had major surgery within the past 3 months, or who have not fully healed from major surgery within the past month, or from minor surgery within the past 10 days.
• People who are pregnant or breastfeeding.
• People who have had another cancer diagnosis within the past 2 years, except for certain minor skin cancers.
• People with serious or unstable medical or psychiatric conditions that could affect their safety or ability to participate in the trial.
• People taking long-term medications that are known to interact with cabozantinib or temozolomide (confirm specific drugs with trial site).

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