A Study to Assess the Effectiveness and Safety of UGN-102 as a Primary Chemoablation Agent in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (LG NMIBC) at Intermediate Risk of Recurrence

Overview

About this study

The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 years of age.
  • 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 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).
  • Has negative voiding cytology for 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 female partner 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/μL (≥3×109/L), Absolute neutrophil count ≥1,500/μL (≥1.5×109/L), Platelets ≥100,000/μL (≥100×109/L), Hemoglobin ≥9.0 mg/dL, Total bilirubin ≤1.5 upper limit of normal (ULN), AST (SGOT)/ALT (SGPT) ≤2.5 × upper limit of normal (ULN), ALP ≤2.5 × ULN, and 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 medication will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of study medication is left to the discretion of the Principal Investigator (PI).

Exclusion Criteria:

  • History of Carcinoma in Situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
  • Received Bacillus Calmette-Guérin (BCG) treatment for 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 (i.e., 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 post-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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Tyson, M.D., M.P.H.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Tyson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Mark Tyson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions