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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

Pivotal Trial

No Placebo-Only Group

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Score for the Post-instillation Patient Questionnaire

Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.

+2 more

Secondary study objectives

Complete Response Rate (CRR)

Side effects data

From 2023 Phase 3 trial • 8 Patients • NCT05136898

25%

Urinary tract infection

25%

Dysuria

25%

Fatigue

25%

Hypertonic bladder

13%

Benign prostatic hyperplasia

13%

Urine flow decreased

13%

Pneumonia

13%

Pollakiuria

13%

Renal cell carcinoma

13%

Sinus tachycardia

13%

Skin irritation

13%

Anxiety

13%

Cerebrovascular accident

13%

Atrial flutter

13%

Depression

13%

Haematuria

13%

Rash

13%

Carotid artery stenosis

13%

Dermatitis contact

13%

Leukocytosis

13%

Procedural pneumothorax

13%

Micturition urgency

13%

Embolic stroke

13%

Intracranial aneurysm

13%

Delirium

13%

Hypertension

13%

Pleural effusion

13%

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

UGN-102

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UGN-102Experimental Treatment1 Intervention

Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin). 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

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