Phase 2 Bladder 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 who are able to understand the study and are willing to sign a written consent form agreeing to take part
• People who agree to take part in a related biological sample storage study (a separate biorepository study at the same institution)
• People aged 18 or older, of any gender
• People whose general health and ability to carry out daily activities falls within an acceptable range (rated 0–2 on a standard medical scale, meaning they are fully active to capable of all self-care but unable to do heavy physical work)
• Women who could potentially become pregnant must have a negative blood pregnancy test within 72 hours before starting treatment
• People who have been diagnosed with muscle-invasive bladder cancer and who are either unable to receive cisplatin (a specific chemotherapy drug) or have chosen not to receive it — ineligibility for cisplatin is determined by specific medical criteria such as significant nerve damage, significant hearing loss, reduced kidney function, or moderate-to-severe heart failure
• People whose blood counts, kidney, and liver function meet specific minimum levels required by the trial (confirm with trial site for exact values)
• People who have normal levels of a specific enzyme called G6PD (glucose-6-phosphate dehydrogenase)
• Women who could potentially become pregnant, and men whose partners could potentially become pregnant, must agree to use approved contraception during the study and for a set period after treatment ends (6 months for women, 3 months for men), or to abstain from sexual activity during that time; men must also agree not to donate sperm during this period

Who may not be able to join:

• People who are currently enrolled in another clinical trial that involves a treatment or therapy
• People who are currently using, or planning to use, other cancer-fighting or experimental drugs while participating in this study
• People who have a diagnosed psychiatric illness or personal circumstances that would make it difficult to follow the study requirements
• People who are currently pregnant or breastfeeding, as the treatment may cause harm to an unborn baby or a breastfeeding infant
• Women who are planning to become pregnant during treatment or within 6 months of the last dose, or men planning to father a child during treatment or within 3 months of the last dose
• People who have had a severe allergic reaction to any ingredient in the study drug
• People who have had a serious active infection (viral, bacterial, or fungal, rated Grade 3 or 4 on a standard medical severity scale) within the 2 weeks before starting the study treatment
• People with other serious uncontrolled health conditions, such as active infection, uncontrolled high blood pressure, unstable heart conditions, certain lung diseases, or serious ongoing digestive conditions causing diarrhoea
• People whose bladder cancer biopsy sample shows a tumour made up entirely of certain specific cell types (pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma)
• People who currently use tobacco products — participants may be asked to stop smoking for at least 2 weeks before joining, and tobacco use may be tested during the trial
• People who have a history of G6PD enzyme deficiency
• People with a history of kidney stones made of oxalate (confirm with trial site, as this may be considered case by case)

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