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

  • STATUS
    Recruiting
  • End date
    Dec 9, 2023
  • participants needed
    632
  • sponsor
    UroGen Pharma Ltd.
Updated on 9 July 2021
Investigator
Christine Lentowski
Primary Contact
Chesapeake Urology Research Associates (9.3 mi away) Contact
+124 other location
anesthesia
cancer
neutrophil count
EGFR
mitomycin
bladder cancer
invasive bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision
transurethral resection of bladder tumor

Summary

This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without () transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

Description

Eligible patients will be randomized in a 1:1 ratio to UGN-102 TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 TURBT group will receive 6 once-weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone group will undergo TURBT.

Patients in both treatment groups will return to the clinic at approximately 3 months after the initiation of treatment (7 weeks 1 week after the last weekly instillation for the UGN-102 TURBT group and 12 weeks 1 week after TURBT for the TURBT alone group) to determine response to treatment. Patients determined to have a complete response (CR) will receive no further treatment and will enter the follow-up period of the study. Patients determined to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and will then enter the follow-up period of the study.

During the follow-up period, patients will return to the clinic every 3 months to determine durability of response. Patients will remain on study until completion of all follow-up visits (approximately 24 months after the initiation of treatment) or until recurrence or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.

The study is event-driven and patients may be followed beyond 24 months or additional patients may be enrolled to achieve the target number of events required for the study.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Transitional cell carcinoma, Transitional Cell Carcinoma of the Bladder, Urothelial Cancer, Urothelial Carcinoma Bladder, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, Urothelial Carcinoma, transitional cell carcinoma of bladder, carcinoma of the bladder, bladder tumor
Treatment UGN-102, TURBT
Clinical Study IdentifierNCT04688931
SponsorUroGen Pharma Ltd.
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Is at intermediate risk for progression, 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 high grade (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 L
Absolute neutrophil count 1,500 cells per L
Platelets 100,000 per L
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 Criteria

History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment
Received Bacillus Calmette-Gurin (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 grading 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 post 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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