Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from the 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 who have a well-differentiated (slow-growing), locally advanced or spread neuroendocrine tumour (NET) of the digestive tract, lung, or pancreas, and who have received no more than 2 previous treatments (not counting somatostatin analog drugs such as octreotide)
• People with a hormone-producing (functional) NET, provided they have been on a stable dose of a somatostatin analog drug for at least 12 weeks and their tumour has continued to grow or spread during that time
• People who have at least one tumour that can be measured on a scan using standard criteria
• People aged 18 or older
• People who are generally well enough to carry out light activity and care for themselves, as assessed by a standard medical scale (confirm with trial site)
• People whose liver is working well enough, based on blood test results within accepted ranges (confirm with trial site)
• People whose kidneys are working well enough, based on blood test results within accepted ranges (confirm with trial site)
• People whose blood counts (white cells, platelets, and haemoglobin) are within accepted ranges, even if support medications are needed to achieve this
• People whose fasting blood fat levels (triglycerides and cholesterol) are within accepted ranges
• People who have had at least 4 weeks since any major surgery or radiation treatment and have largely recovered from any side effects of past treatments
• People who are not pregnant or breastfeeding; women who could become pregnant must agree to use effective contraception from 28 days before starting treatment until 3 months after the last dose, and must have a negative pregnancy test at the start; men must agree to use contraception and not donate sperm during the study and for 3 months after the last dose
• People who are able and willing to attend scheduled visits, undergo tests, and follow all study procedures
• People with a known history of HIV infection may be eligible if they have not had a serious HIV-related illness in the past 12 months, have been on a stable HIV treatment for at least 4 weeks, have a very low HIV viral level in their blood, and their HIV medications do not interact with the study drug (confirm with trial site)
• People (or their legal guardian) who are able to read and sign the informed consent form

Who may not be able to join:

• People who have previously been treated with a type of drug called an mTOR inhibitor, including nab-sirolimus (the study drug itself)
• People with a hormone-producing NET whose tumour-related symptoms (such as flushing or diarrhoea) are not well controlled
• People whose tumour has specific genetic changes in the TSC1 or TSC2 genes, identified through tumour or blood genetic testing
• People who have a serious active infection (grade 3 or worse) that requires antibiotic or antifungal treatment, either currently or completed within the last 7 days
• People with cancer spread to the brain, or suspected brain involvement
• People with serious heart problems, including unstable chest pain, severe heart failure, a heart attack within the past 6 months, or serious uncontrolled heart rhythm problems
• People with severely reduced lung function or low blood oxygen levels at rest
• People with other serious or uncontrolled medical or psychiatric conditions that could affect their ability to participate safely
• People with uncontrolled high blood pressure (systolic 160 mmHg or higher and/or diastolic 100 mmHg or higher)
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease, pneumonitis) or high blood pressure in the lungs
• People with active Hepatitis B or C infection with a detectable viral level, despite antiviral treatment
• People with another cancer diagnosis within the past 5 years (some exceptions may apply, such as certain skin cancers or other low-risk conditions — confirm with trial site)
• People who need to take certain medications that strongly interact with the study drug (including some antifungals, some antibiotics such as erythromycin or clarithromycin, and some medications such as rifampin) — these medications would need to be stopped before the study drug could be started

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