At a glance
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Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
In Brief
A Phase 2 clinical trial evaluating NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, and 2 other interventions for Bladder Cancer and 8 related conditions. Completed, enrolled 36 participants across 5 sites.
Detailed Summary
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 Details
Timeline
Interventions
Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.