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Anti-tumor antibiotic

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive 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

No Placebo-Only Group

Pivotal 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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 months

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

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

Primary study objectives

Disease-free Survival (DFS)

Secondary study objectives

Changes From Baseline in Health-related Quality of Life

Complete Response Rate (CRR)

Duration of Response (DOR)

+6 more

Side effects data

From 2023 Phase 3 trial • 8 Patients • NCT05136898

25%

Fatigue

25%

Hypertonic bladder

25%

Urinary tract infection

25%

Dysuria

13%

Pollakiuria

13%

Procedural pneumothorax

13%

Micturition urgency

13%

Cerebrovascular accident

13%

Hypertension

13%

Intracranial aneurysm

13%

Anxiety

13%

Delirium

13%

Haematuria

13%

Hypoaesthesia

13%

Sinus tachycardia

13%

Skin irritation

13%

Atrial flutter

13%

Depression

13%

Pneumonia

13%

Urine flow decreased

13%

Leukocytosis

13%

Benign prostatic hyperplasia

13%

Embolic stroke

13%

Rash

13%

Carotid artery stenosis

13%

Pleural effusion

13%

Dermatitis contact

13%

Renal cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

UGN-102

Awards & 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

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 with NCR due to residual LG disease 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 with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UGN-102

2018

Completed Phase 3

~80

TURBT

2017