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Chemotherapy

UGN-102 for Bladder Cancer

Phase 3
Waitlist Available
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 3 months
Awards & highlights

Summary

This trial is testing if UGN-102 can be given at home to treat a type of bladder cancer that is not very aggressive but has a chance of coming back. The goal is to make treatment easier and more comfortable for patients by avoiding trips to the clinic.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Feasibility questionnaires
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and abnormal clinical laboratory tests (hematology, serum chemistry, and urinalysis).
Secondary outcome measures
Complete response rate (CRR)

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%
Nocturia
6%
Urinary retention
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: UGN-102Experimental Treatment1 Intervention
Patients will receive 6 once-weekly intravesical instillations of UGN-102. Treatment Visit 1 will occur at the investigative site and instillation will be performed by a qualified physician. Treatment Visits 2 to 6 will occur at the patient's home and instillation will be performed by a properly trained and qualified home health professional.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UGN-102
2018
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

UroGen Pharma Ltd.Lead Sponsor
18 Previous Clinical Trials
1,320 Total Patients Enrolled
Sunil Raju, MDStudy DirectorUroGen Pharma
Takekazu Aoyama, MD, PhDStudy DirectorUroGen Pharma
~2 spots leftby Sep 2025
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