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Anti-tumor antibiotic

UGN-102 for Bladder Cancer (ATLAS Trial)

Phase 3
Waitlist Available
Led By Sandip Prasad, MD
Research Sponsored by UroGen Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights

ATLAS Trial Summary

This trial is testing a new treatment for patients with low grade bladder cancer. The new treatment is mitomycin (UGN-102) given as an intravesical solution with or without TURBT.

Eligible Conditions
  • Bladder Cancer

ATLAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival (DFS)
Secondary outcome measures
Changes from baseline in health-related quality of life
Heart rate
Duration of response (DOR)
+4 more

Side effects data

From 2020 Phase 2 trial • 63 Patients • NCT03558503
41%
Dysuria
21%
Pollakiuria
14%
Micturition urgency
14%
Urinary tract infection
14%
Hematuria
11%
Fatigue
8%
Urinary incontinence
6%
Urinary retention
6%
Nocturia
6%
Vulvovaginal discomfort
6%
Pruritus genital
6%
Accidental exposure to product
2%
Cardiac disorder
2%
Chronic obstructive pulmonary disease
2%
Stress cardiomyopathy
2%
Acute myeloid leukemia
2%
Pneumonia klebsiella
2%
Gastroenteropancreatic neuroendocrine tumor disease
2%
Transitional cell carcinoma metastatic
2%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
UGN-102

ATLAS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UGN-102 ± TURBTExperimental Treatment2 Interventions
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients who have a NCR at the 3-month Visit (3 months after the start of treatment with UGN-102).
Group II: TURBT AloneActive Control1 Intervention
TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month Visit (3 months after the initial TURBT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TURBT
2017
Completed Phase 3
~1700
UGN-102
2018
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

UroGen Pharma Ltd.Lead Sponsor
17 Previous Clinical Trials
959 Total Patients Enrolled
Sandip Prasad, MDPrincipal InvestigatorAtlantic Health System
1 Previous Clinical Trials
220 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA greenlit UGN-102 for therapeutic use?

"UGN-102 has been studied in multiple Phase 3 trials, which is the gold standard for clinical research. This gives us confidence that it is a safe medication."

Answered by AI

What is the precedent for UGN-102 in medical research?

"The study of UGN-102 began in 2007 at the Labbafinejad Medical Center in Tehran. So far, there have been 58 completed studies and 45 ongoing trials. Many of these ongoing studies are taking place in San Antonio, Texas."

Answered by AI

What are the most common maladies that UGN-102 is effective against?

"UGN-102 is most commonly used to treat cervical cancer. However, it has also been found useful in treating other conditions such as low-grade upper tract urothelial cancer (lg-utuc), mesotheliomas, and glaucoma."

Answered by AI

How many different facilities are helping to manage this clinical trial?

"There are 35 locations enrolling patients for this clinical trial, which are situated in cities such as San Antonio, Santa Monica and Bloomfield. To limit travel if you choose to enroll, it is best to select a site near you."

Answered by AI
~69 spots leftby Mar 2025