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:

• Adults aged 18 or older who have been diagnosed with a neuroendocrine tumour (NET) or meningioma (a type of brain tumour) and have not previously received a type of radiation treatment called PRRT.
• People whose cancer is locally advanced, cannot be surgically removed, or has spread to other parts of the body (specific tumour types are required depending on which part of the trial a person joins — confirm with trial site).
• People with meningioma whose diagnosis has been confirmed by tissue testing and falls into any grade (1, 2, or 3) under the World Health Organization brain tumour classification system.
• People whose tumours can be measured on a CT or MRI scan, with imaging taken within the required timeframe before joining.
• People whose tumours have shown signs of growth or spread on scans in the 12 months before joining the trial.
• People whose tumours show a specific protein on the surface called a somatostatin receptor, confirmed by a specialised PET scan using an approved imaging agent.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG scale, where 0 means fully active and 1 means slightly restricted — confirm with trial site).
• People living with HIV, provided their immune cell count (CD4) is above 350 cells per microlitre.
• People currently taking a type of hormone-blocking medication called a somatostatin analogue (SSA), provided they are able to pause the long-acting form for at least 28 days and the short-acting form for at least 24 hours before each treatment dose.
• People with NETs whose disease has continued to progress despite other approved treatments (not including radionuclide therapy).
• People with meningioma who are taking steroid medication, provided the daily dose is no more than 4 mg of dexamethasone (or an equivalent steroid) for at least 7 days before starting treatment.
• People with tumours that produce stress hormones (pheochromocytoma or paraganglioma) who have received appropriate medication to manage those hormones.
• People who are able to understand and sign a consent form and follow all study requirements.
• People with a life expectancy of more than 3 months.
• People whose kidney, liver, and blood test results show that their organs are functioning at an adequate level.
• Women of childbearing potential who agree to use highly effective contraception and to not donate eggs from the screening period through to at least 6 months after the last treatment dose.
• Men of reproductive potential who agree to use condoms or other effective contraception with their partner and to not donate sperm from the screening period through to at least 6 months after the last treatment dose.

Who may not be able to join:

• People with a known allergic reaction to somatostatin analogues, somatostatin receptor imaging agents, or any ingredient in the trial treatment.
• People who have another cancer that is currently growing or requires active treatment.
• People who are pregnant or currently breastfeeding.
• People who develop a fever within 48 hours of a scheduled treatment dose (the dose would need to be rescheduled to more than 48 hours after the fever resolves).
• People who have taken part in another clinical trial involving an experimental medicine within the 30 days before the planned start of treatment.
• People who have previously received PRRT-based treatments such as those using yttrium-90 or lutetium-177 (e.g., [177Lu]DOTATATE).
• People who have received a specific type of internal radiation treatment to the liver (yttrium-90 radioembolisation) unless it was completed at least 6 months before joining.
• People who have received external beam radiation therapy unless it was completed at least 30 days before joining.
• People who have received other systemic anti-cancer treatments unless those were completed at least 30 days before joining (an exception may apply for somatostatin analogues in people with hormone-producing tumours — confirm with trial site).
• People who have had major surgery unless it was completed at least 30 days before joining.
• People with NETs who have cancer that has spread to the brain, unless those brain tumours were treated and stable at least 6 months before joining and steroid medication for that condition was stopped at least 14 days before joining.
• People who have had an active infection requiring antibiotics or antifungal medication in the 3 days before joining.
• People who have received a live vaccine in the 7 days before joining.
• People experiencing severe nausea, vomiting, or diarrhoea in the 72 hours before the first planned treatment dose, despite receiving appropriate supportive care.
• People with a known medical condition that would make participation in this trial unreasonably risky.
• People with a history of severe allergic reactions such as anaphylaxis or severe swelling (angioedema) to any known components of the trial treatment.
• People currently misusing alcohol or illicit drugs (medically prescribed cannabinoids are excluded from this criterion).
• People with medical or personal circumstances that may interfere with their ability to follow study requirements, including radiation safety precautions.
• People with a specific irregularity in their heart's electrical activity (QTc interval greater than 450 milliseconds — confirm with trial site).

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