This is a clinical trial studying the administration of NanoDoce as a direct injection to
the bladder wall immediately after tumor resection and as an intravesical instillation.
All participants will receive NanoDoce, and will be evaluated for safety and
tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03636256.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Name Not Available
In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer
(NMIBC) or muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be
stratified into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects
will receive NanoDoce injected into the index tumor resection site on the bladder wall,
immediately following transurethral resection of the bladder tumor (TURBT), followed by
an initial NanoDoce intravesical instillation.
Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects
will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations,
followed by 6 weeks of rest). After the Induction period, following confirmation of
non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly
NanoDoce intravesical instillations, followed by 9 weeks of rest).
After NanoDoce direct injection and the initial intravesical instillation, Group 2
subjects will proceed to institutional standard of care and will not receive Induction or
Maintenance intravesical instillations.
Lead OrganizationNanOlogy, LLC
