Status:
TERMINATED
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Lead Sponsor:
UroGen Pharma Ltd.
Conditions:
Bladder Cancer
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethra...
Detailed Description
Eligible patients were randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization was stratified by the presence of a previous LG-NMIBC episode within 1 year of the current diagnosis (...
Eligibility Criteria
Inclusion
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening.
- Has intermediate risk disease, 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).
- Negative voiding cytology for HG disease within 6 weeks of Screening.
- Has adequate organ and bone marrow function as determined by the following routine laboratory tests:
- Leukocytes ≥ 3,000 cells per μL;
- Absolute neutrophil count ≥ 1,500 cells 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 (ALP) ≤ 2.5 × ULN;
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
- Has no evidence of active urinary tract infection (UTI).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.
Exclusion
- 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 1 year.
- History of HG papillary UC in the past 2 years.
- Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
- 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 UC.
- Current tumor stage of T1.
- 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.
- History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT.
- Has previously participated in a study in which they received UGN-102.
- Has participated in a study with an investigational agent or device within 30 days of randomization.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT04688931
Start Date
February 19 2021
End Date
March 17 2023
Last Update
June 6 2024
Active Locations (139)
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1
Arizona Institute of Urology, PLLC
Tucson, Arizona, United States, 85704
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92350
3
Urology Group of Southern California
Los Angeles, California, United States, 90017
4
San Diego Clinical Trials
San Diego, California, United States, 92120