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

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-009049
    • Scottsdale/Phoenix, Arizona: 18-009049
    • Jacksonville, Florida: 18-009049
    NCT ID: NCT03558503
    Sponsor Protocol Number: TC-BC-12

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Tyson, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Tyson, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Tyson, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20450259

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