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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04046094
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
* Cisplatin-ineligible, muscle invasive bladder cancer
* Adequate organ and marrow functions
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control
Exclusion Criteria:
* Patient simultaneously enrolled in any therapeutic clinical trial
* Current or anticipated use of other investigational agents while participating in this study
* Psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
* Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
* Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
* Uncontrolled intercurrent illness
* Current consumption of tobacco products
* History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04046094
Study Brief:
Protocol Section:
NCT04046094