MedTrace Logo

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT04688931 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2024-06-06

Study results available
· View outcomes & findings →

Summary

This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Conditions

Interventions

DRUG

UGN-102

UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

PROCEDURE

TURBT

The current standard of care for treatment of LG-IR-NMIBC is TURBT under general anesthesia.

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Sandip Prasad, MD · Atlantic Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2023-03-17
Completion
2023-03-17
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Estonia
  • Georgia
  • Israel
  • Latvia
  • Poland
  • Russia
  • Serbia
  • Ukraine

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 NCT04688931 on ClinicalTrials.gov