NCT03636256

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: NanOlogy, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bladder Cancer
• Urothelial Carcinoma
• Urinary Bladder Neoplasm
• Urinary Bladder Cancer
• Urogenital Neoplasms
• Urologic Neoplasms
• Urologic Cancer
• Malignant Tumor of the Urinary Bladder
• Cancer of the Bladder

Interventions

Type	Name	Description
DRUG	NanoDoce (direct injection)	Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
DRUG	NanoDoce (intravesical instillation) - Visit 2 Instillation	All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
OTHER	Institutional Standard of Care	Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
DRUG	NanoDoce (intravesical instillation) - Induction and Maintenance Instillations	Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.

Timeline

• Start date: 2019-04-02
• Primary completion: 2021-11-02
• Completion: 2021-11-02
• First posted: 2018-08-17
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study