Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT02360618
Eligibility Criteria:
Inclusion Criteria
1. Age ≥18 years and 85≤.
2. Patients must have biopsy proven invasive bladder cancer by TURBT, previously untreated prior to TURBT by systemic chemotherapy.
3. Patients must be able to swallow and tolerate oral medication
4. Hemoglobin A1c ≤ 6.5%.
5. Able to comprehend written and verbal study instructions related to study protocol and provide informed consent.
6. Any women with childbearing potential must use a highly effective contraception method, of which include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
Exclusion Criteria
1. Patient has been treated for a prior cancer diagnosis with cisplatin-derived chemotherapy regimens or has had pelvic radiation therapy.
2. Previous or current diagnosis of type 1 or 2 diabetes mellitus.
3. Metformin exposure within the previous 12 months.
4. Expected or simultaneous use of sulfonylureas, thiazolidinediones, or insulin.
5. Known metformin allergy or intolerance.
6. Participation in another drug trial either within 30 days prior to study enrollment or during the time when they are on study protocol.
7. Serious cardiovascular disease including myocardial infarction within 6 months, unstable angina, serious cardiac arrythmias excluding atrial fribrillation, or cerebrovascular accident within 6 months prior to screening visit.
8. Abnormal liver function tests: Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \> 1.8 X upper limit of normal
9. Estimated glomerular filtration rate (eGFR) of ≤40 mL/min.
10. History of other malignancy, except non-muscle invasive bladder cancer, treated non-melanoma skin cancer, stage I melanoma and solid tumors adequately treated, with no persistent evidence of disease for 5 years.
11. Concomitant medical condition predisposing to metformin hydrochloride-associated lactic acidosis; examples include NYHA class III or IV congestive heart failure, history of acidosis and chronic alcohol intake averaging ≥ 4 beverages per day.
12. A history of rhabdomyolysis.
13. The use of medications including niacin and colchicine, as well as strong inhibitors of cytochrome p-450 3A4 (see list in section 4.2).
14. Untreated hypothyroidism.
15. Pregnancy.
16. Breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02360618
Study Brief:
Protocol Section:
NCT02360618