MedTrace Logo

A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

NCT03558503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-09-16

Study results available
· View outcomes & findings →

Summary

This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in 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, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Elyse Seltzer, MD · UroGen Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-01-03
Completion
2020-10-21
FDA Drug
Yes

Countries

  • United States
  • Israel

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 NCT03558503 on ClinicalTrials.gov