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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

Study Summary

This trial is testing whether it's just as good to do a medical procedure at home as it is in a clinical setting.

Eligible Conditions

Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Urinary incontinence

Urinary retention

Nocturia

Vulvovaginal discomfort

Pruritus genital

Accidental exposure to product

Cardiac disorder

Chronic obstructive pulmonary disease

Stress cardiomyopathy

Acute myeloid leukemia

Pneumonia klebsiella

Gastroenteropancreatic neuroendocrine tumor disease

Transitional cell carcinoma metastatic

Pneumonia

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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, MBBSStudy DirectorUroGen Pharma

1 Previous Clinical Trials

87 Total Patients Enrolled

Sunil Raju, MDStudy DirectorUroGen Pharma

Frequently Asked Questions

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

Why do people usually take UGN-102?

"UGN-102 is a medication that is most often prescribed to patients with cervical cancer. It can also be used as part of treatments for lg-utuc, glaucoma, and mesotheliomas."

Answered by AI

Are there any short-term dangers associated with taking UGN-102?

"UGN-102 is a promising medication that has received a 3 for safety from our team at Power. This rating comes because UGN-102 is in Phase 3 clinical trials, meaning that there is already some data to support its efficacy and multiple rounds of data affirming its safety."

Answered by AI

Are there a plurality of locations where this experiment is taking place within the confines of our state?

"Right now, there are 5 sites where this trial is enrolling patients. They are in Homewood, Nashville, Greensboro and other places too. If you want to make travel easier, try and pick a location near you."

Answered by AI

Can you provide some context for this UGN-102 study by listing other similar studies that have been completed?

"There are currently 45 clinical trials studying the effects of UGN-102. 12 of those trials are in Phase 3, which is the final stage before potential approval. The majority of trials for this medication are taking place in Bethesda, Maryland, but there are a total of 2070 locations running clinical trials for this treatment across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC)

2021. "Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136898.