Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ramy Yaacoub, MD

Description

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).

Official Title

A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (LG IR NMIBC)

Details

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.

Keywords

Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder Non-muscle invasive bladder cancer Low grade non-muscle invasive bladder cancer Intermediate risk non-muscle invasive bladder cancer NMIBC UGN-102 Mitomycin Transurethral resection of bladder tumors TURBT Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Mitomycins UGN-102 ± TURBT TURBT Alone

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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.
  2. Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 8 weeks of screening.
  3. Is at intermediate risk for progression, defined as having 1 or 2 of the following:
  4. Presence of multiple tumors;
  5. Solitary tumor > 3 cm;
  6. Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
  7. Negative voiding cytology for high grade (HG) disease within 6 weeks of screening.
  8. Has adequate organ and bone marrow function as determined by the following routine laboratory tests:
  9. Leukocytes ≥ 3,000 cells per μL;
  10. Absolute neutrophil count ≥ 1,500 cells per μL;
  11. Platelets ≥ 100,000 per μL;
  12. Hemoglobin ≥ 9.0 g/dL;
  13. Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
  14. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
  15. Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
  16. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
  17. Has no evidence of active urinary tract infection (UTI).
  18. 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.

You CAN'T join if...

  1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
  2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
  3. History of HG papillary UC in the past 2 years.
  4. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
  5. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
  6. History of pelvic radiotherapy.
  7. History of:
  8. Neurogenic bladder;
  9. Active urinary retention;
  10. Any other condition that would prohibit normal voiding.
  11. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.
  12. Current tumor grading of T1.
  13. . 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.
  14. . History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately post any previous TURBT.
  15. . Has previously participated in a study in which they received UGN-102.
  16. . Has participated in a study with an investigational agent or device within 30 days of randomization.

Locations

  • UC Irvine Health not yet accepting patients
    Orange California 92868 United States
  • Urology Group of Southern California accepting new patients
    Los Angeles California 90017 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UroGen Pharma Ltd.
ID
NCT04688931
Phase
Phase 3
Study Type
Interventional
Last Updated