A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
Condition: Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms
Intervention: UGN-102
Intervention description: UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-muscle invasive bladder cancer; Low grade non-muscle invasive bladder cancer; Intermediate risk non-muscle invasive bladder cancer; NMIBC; UGN-102; Mitomycin

Summary:

      This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as
      primary chemoablative therapy in patients with low grade intermediate risk
      non-muscle-invasive bladder cancer (LG IR NMIBC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to sign an informed consent and comply with the protocol.

          2. Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup
             biopsy at screening or within 6 weeks of screening.

          3. Is at intermediate risk of recurrence, 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).

          4. Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of
             enrollment.

          5. Willing to use 2 acceptable forms of effective contraception from enrollment through 6
             months post treatment if the participant is female or the female partner of a male
             participant and is of childbearing potential (defined as premenopausal women who have
             not been sterilized).

          6. Has adequate organ and bone marrow function as determined by routine laboratory tests
             as below:

               -  Leukocytes ≥ 3,000 per μL;

               -  Absolute neutrophil count ≥ 1,500 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 ≤ 2.5 × ULN;

               -  Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

          7. 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 drug will be postponed until resolution. In the case of
                  asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of
                  study drug is left to the discretion of the Principal Investigator (PI).

        Exclusion Criteria:

          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 2 years.

          3. History of HG papillary UC in the past 2 years.

          4. Known allergy or sensitivity to mitomycin.

          5. Clinically significant urethral stricture that would preclude passage of a urethral
             catheter.

          6. History of pelvic radiotherapy.

          7. History of:

               -  Neurogenic bladder;

               -  Active urinary retention;

               -  Any other condition that would prohibit normal voiding.

          8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper
             tract urothelial carcinoma (UTUC).

          9. Has participated in a study with an investigational agent or device within 30 days of
             enrollment.

         10. History of prior treatment with an intravesical chemotherapeutic agent with the
             exception of a single dose of chemotherapy immediately after any previous
             transurethral resection of bladder tumors (TURBT).

         11. 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.