Phase 2 Bladder 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 been fully informed about the study and have voluntarily agreed in writing to take part and follow the study process.
• Adults aged 18 or older at the time of signing consent, of any gender.
• People who had a bladder tumour removal procedure (called TURBT) completed within the 12 weeks before the first treatment, where tissue testing confirmed a diagnosis of bladder cancer that has not grown into the bladder muscle, and which is classified as high risk according to specific international guidelines.
• People whose bladder cancer did not respond to, came back after, or who could not tolerate BCG treatment (a common bladder cancer therapy given directly into the bladder), and who either cannot have or have chosen not to have their bladder surgically removed.
• People for whom it has been confirmed that the bladder tumour was completely removed during the TURBT procedure, including people who may have needed a second TURBT to ensure complete removal (confirm with trial site for details on when a second procedure is required).
• People with a general physical fitness level rated as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work).
• People with an expected survival of at least 6 months.
• People whose major organs are working well enough to meet specific blood, liver, and kidney test results as assessed by the trial site.

Who may not be able to join:

• People whose bladder cancer has grown into the bladder muscle (stage T2–T4).
• People whose urothelial cancer affects other parts of the urinary tract (such as the kidneys or ureters), or where cancer has spread to the lymph nodes.
• People with a history of a condition where urine flows backwards from the bladder toward the kidneys (vesicoureteral reflux).
• People who have had another type of cancer within the past 2 years, except for certain easily treated skin cancers or cervical carcinoma in situ that have been fully cured.
• People who have not recovered from significant side effects of previous cancer treatments (confirm with trial site for specific recovery thresholds), or who have certain active or uncontrolled infections, breathing problems, kidney problems, bladder perforation, or urinary blockage within 3 days before the first dose.
• People with serious or uncontrolled heart conditions, including certain abnormal heart rhythms, a heart attack or heart procedure within the past 6 months, severe heart failure, or abnormal heart electrical readings above specific thresholds on testing.
• People with uncontrolled high blood pressure while on treatment, defined as a reading of 160/100 mmHg or higher.
• People with nerve damage in the hands or feet rated above a mild level (above grade 1).
• People with a known or suspected allergy to docetaxel (the study drug) or similar medicines.
• People who have previously received treatment with docetaxel.
• People who have previously had extensive radiation therapy to the pelvis covering more than 30% of the bone marrow area.
• People who have had major surgery within 28 days before the first dose, or who have not sufficiently recovered from surgery.
• People who have received any treatment directly into the bladder within 28 days before the first dose (with a specific exception — confirm with trial site).
• People who have received chemotherapy, radiation, targeted therapy, immunotherapy, biological therapy, or herbal cancer medicines within 28 days or 5 half-lives of those drugs (whichever is longer) before the first dose.
• People who have taken part in another clinical trial treatment within 28 days or 5 half-lives (whichever is longer) before the first dose.
• People who plan to receive other cancer treatments or experimental drugs during the study.
• People who are pregnant or breastfeeding, or people of childbearing potential who test positive for pregnancy within 7 days before the first dose, or who are unwilling to use highly effective contraception throughout the trial and for 30 days after the last dose.
• People with a known history of psychiatric disorders, substance abuse, or alcohol or drug addiction that may affect their ability to follow the study requirements.
• People who, in the opinion of the trial doctor, would face unnecessary risk from taking part, or are otherwise considered unsuitable for the study.

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