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Chemotherapy
UGN-103 for Bladder Cancer (UTOPIA Trial)
Phase 3
Recruiting
Research Sponsored by UroGen Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of multiple tumors.
Solitary tumor > 3 cm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
" This trial will test a new treatment called UGN-103 for patients with a certain type of bladder cancer. The study will look at how well the treatment works and if it is safe for patients
Who is the study for?
This trial is for patients with a type of bladder cancer called low-grade non-muscle invasive bladder cancer (LG-NMIBC). Participants must have had at least one prior episode, may have multiple tumors or a tumor larger than 3 cm, and should show signs of early or frequent recurrence. They need normal blood counts and no high-grade disease in recent tests. Patients must consent to follow the study rules.
What is being tested?
The trial is testing UGN-103, which is an updated version of UGN-102. It's given as a treatment directly into the bladder for those with LG-NMIBC. The goal is to see how effective and safe this new formulation is when used by itself in patients.
What are the potential side effects?
Specific side effects are not listed here but typically, treatments instilled in the bladder can cause discomfort during urination, increased frequency or urgency to urinate, possible blood in urine, and risk of urinary tract infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have more than one tumor.
Select...
My tumor is larger than 3 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response rate (CRR)
Secondary study objectives
Durable complete response (DCR) rate
Duration of response (DOR)
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: UGN-103Experimental Treatment1 Intervention
Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses).
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Who is running the clinical trial?
UroGen Pharma Ltd.Lead Sponsor
18 Previous Clinical Trials
1,261 Total Patients Enrolled
Sunil Raju, MBBSStudy DirectorUroGen Pharma
2 Previous Clinical Trials
68 Total Patients Enrolled
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