A Rollover Study to Follow the Long-term Durability of Response to UGN-103 in Participants With Recurrent Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (LG-IR-NMIBC) From Study BL013

Study Identifier:
UGN-103-401
CT.gov Identifier:
N/A
EudraCT Identifier:
202652635975
EU Trial (CTIS) Number:
2026-526359-75-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To Collect long-term durability of response data from participants with an ongoing complete response to UGN-103 at the end of Study BL013

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase IV
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Patients will receive UGN-103
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • 1. Participant has provided written informed consent for the rollover study.
  • 2. Participant completed Study BL013 with an ongoing CR
Exclusion criteria
  • 1. Participant has not provided written informed consent for the rollover protocol.
  • 2.Participant did not complete Study BL013 with an ongoing CR

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Abhishek Srivastava
Status
Recruiting
Condition(s) Treated at Site
Bladder