MedTrace Logo

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

NCT03636256 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-14

Study results available
· View outcomes & findings →

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.

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

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.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Donald Lamm, MD, FACS · BCG Oncology, PC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2021-11-02
Completion
2021-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636256 on ClinicalTrials.gov