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 years or older
• Men, or women who are not pregnant and who agree to follow the contraception requirements set out in the study protocol
• People who have a gastrointestinal (digestive system) cancer that has spread to other parts of the body or cannot be removed by surgery, confirmed by laboratory testing of tumour tissue — and for one specific group (Arm VII), only those who have received exactly one prior treatment for their advanced cancer
• People whose cancer can be measured using standard imaging guidelines (called RECIST v1.1)
• People whose doctors expect them to survive for at least 16 weeks
• People who are up and about and able to carry out light daily activities, with a fitness score of 0 or 1 on the standard ECOG scale
• People whose liver, kidneys, and other organs are functioning well enough to meet the study's requirements
• People who are on stable doses of any medications that might affect how the liver breaks down drugs or how the kidneys clear them
• People who have been fully informed about their illness and the research nature of the study, and who have signed an approved consent form
• For one specific group (Arm VII): people whose tumour has a particular genetic profile known as BRAF wild-type (confirm with trial site)

Who may not be able to join:

• People with significant nerve damage (neuropathy above grade 2)
• People who have previously had a serious reaction or intolerance to the chemotherapy drugs fluorouracil or oxaliplatin
• People who have had a stroke in the six months before treatment would start
• People who have, or have had, cancer that has spread to the brain or the lining around the brain or spinal cord
• People with serious medical conditions that could get worse with treatment or that might make it hard to follow the study requirements
• People with a significant history of heart disease
• People who have coughed up blood, had a brain bleed, or had a significant gastrointestinal bleed in the six months before treatment would start
• People who have had another cancer diagnosed within the three years before treatment would start
• People with an active digestive tract condition that affects the body's ability to absorb nutrients or medications
• People with a wound, bone fracture, or ulcer that is not healing, or who have symptoms of poor blood circulation in the limbs
• People who have had radiation therapy or surgery within four weeks before treatment would start
• People who have lost more than 10% of their body weight in the three months before treatment would start
• People living with HIV who are on combination anti-retroviral therapy, due to possible interactions with the study drug
• People who have received another experimental or anti-cancer treatment within four weeks before treatment would start
• People who are currently breastfeeding
• People who have a deficiency of an enzyme called Dihydropyrimidine Dehydrogenase (DPD), which affects how certain chemotherapy drugs are processed by the body
• People who are currently taking, or have previously taken, strong medications that block the DPD enzyme
• For one specific group (Arm VII): people who have previously been treated with the study drug BOLD-100
• For one specific group (Arm VII): people whose tumour has a characteristic known as microsatellite instability-high (MSI-H) (confirm with trial site)
• For one specific group (Arm VII): people currently receiving certain targeted antibody therapies for colorectal cancer (including anti-EGFR, anti-VEGF, or anti-HER2 treatments)

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