A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

Completed · Phase 2

Conditions studied: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder

In brief

This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

Key facts

Study ID

NCT03558503

Run by

UroGen Pharma Ltd.

People needed

63

Starts

2018-10-15

Expected to finish

2020-10-21

Last updated by the study team

2022-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to sign an informed consent and comply with the protocol.
• Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening.
• Is at intermediate risk of recurrence, defined as having 1 or 2 of the following:
• Presence of multiple tumors;
• Solitary tumor > 3 cm;
• Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
• Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment.
• Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized).
• Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
• Leukocytes ≥ 3,000 per μL;
• Absolute neutrophil count ≥ 1,500 per μL;
• Platelets ≥ 100,000 per μL;
• Hemoglobin ≥ 9.0 g/dL;
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
• Alkaline phosphatase ≤ 2.5 × ULN;
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
• Has no evidence of active urinary tract infection (UTI) at Screening and Baseline visits.
• In the case of symptomatic UTI, the patient will be treated with a full course of antibiotics, and study drug will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of study drug is left to the discretion of the Principal Investigator (PI).

You may not qualify if…

• History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
• Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 2 years.
• History of HG papillary UC in the past 2 years.
• Known allergy or sensitivity to mitomycin.
• Clinically significant urethral stricture that would preclude passage of a urethral catheter.
• History of pelvic radiotherapy.
• History of:
• Neurogenic bladder;
• Active urinary retention;
• Any other condition that would prohibit normal voiding.
• Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).
• Has participated in a study with an investigational agent or device within 30 days of enrollment.
• History of prior treatment with an intravesical chemotherapeutic agent with the exception of a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT).
• Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

Where it is running

• Mayo Clinic Cancer Center — Phoenix, Arizona, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• Loma Linda University — Loma Linda, California, United States
• Providence Medical Institute — Santa Monica, California, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• John Hopkins University — Baltimore, Maryland, United States
• Adult & Pediatric Urology, PC — Omaha, Nebraska, United States
• Urology Las Vegas — Las Vegas, Nevada, United States
• Manhattan Medical Research — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center (Albert Einstein) — New York, New York, United States
• Western New York Urology Associates — New York, New York, United States
• The University of North Carolina — Chapel Hill, North Carolina, United States
• Penn State Hershey State College — Hershey, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates, PC — Nashville, Tennessee, United States
• Urology San Antonio — Fredericksburg, Texas, United States
• Carmel Medical Center — Haifa, Israel
• Rabin Medical Center — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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