A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Qapzola; Placebo
Intervention description: Qapzola administered by the intravesical route.; Qapzole-matching placebo administered by the intravesical route.
Intervention MeSH terms: Apaziquone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk NMIBC.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola
      in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC),
      assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically,
      only participants with the following low-to intermediate-risk tumor characteristics were
      included in the study.

      2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:

      Low Risk

        -  Low grade solitary Ta ≤3 centimeters (cm)

        -  Papillary urothelial neoplasm of low malignant potential (PUNLMP)

      Intermediate Risk

        -  Recurrence within 1 year, low-grade Ta

        -  Solitary low-grade Ta >3 cm

        -  Low-grade Ta, multifocal

        -  High-grade Ta, ≤3 cm (solitary tumor)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must have had a clinical diagnosis of low- to intermediate-risk non-muscle
             invasive bladder cancer according to the 2016 American Urological Association (AUA)
             Guidelines, except for strongly-suspected papillary urothelial neoplasm of low
             malignant potential (PUNLMP).

          2. Participant was willing to give written informed consent and was able to adhere to
             dosing and visit schedules, and meet all study requirements.

          3. Participant was at least 18 years of age and <90 years of age at the time Informed
             Consent is signed.

          4. Participant was willing to practice two forms of contraception, one of which must have
             been a barrier method, from study entry until at least 35 days after study treatment.
             Participants surgically sterilized or who were postmenopausal for at least 1 year
             (defined as more than 12 months since last menses) did not require contraception.

          5. Females of childbearing potential had a negative pregnancy test within 30 days prior
             to randomization. Females who were postmenopausal for at least 1 year (defined as more
             than 12 months since last menses) or were surgically sterilized did not require this
             test.

        Exclusion Criteria:

          1. Participant had malignancy or life-threatening systemic disease or a history of
             advanced, serious, life-threatening malignancy/disease within the last 5 years, except
             very low-risk prostate cancer.

          2. Participant had used any investigational drugs, biologics (vaccines, antibodies), or
             devices within 30 days prior to study treatment or had plans to use any of these
             during the course of the study.

          3. Participant had received any pelvic radiotherapy (including external beam and/or
             brachytherapy).

          4. Participant had a history of allergy to red color food dye or any other component of
             Qapzola, placebo, or their diluents.

          5. Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical
             procedures performed at the time of TURBT or within 4 weeks after TURBT.

          6. Participant had any unstable or uncontrolled medical condition that would make it
             potentially unsafe to undergo TURBT including a previous stroke or myocardial
             infarction within 6 months.

          7. Participant had an active uncontrolled infection, including a urinary tract infection,
             underlying medical condition, or other serious illness that would impair the ability
             of the participant to receive study treatment or undergo study procedures.

          8. Participant had a bleeding disorder or a screening platelet count <100×10^9/per liter
             (L), or required continuous anticoagulation or bridging anticoagulation during the
             procedure.

          9. Participant had a hemoglobin value <10 grams per deciliter (g/dL) at Screening.

         10. Participant had confirmed extravesical urothelial disease (upper tract and urethral
             including prostatic urethral).

         11. Participant had history of previous bladder cancer:

               -  High-Risk NMIBC as classified per the 2016 AUA Guidelines

               -  Bladder cancer that was muscle invasive or positive for lymph node or distant
                  metastasis.

         12. Participant had received any previous intravesical therapy for bladder cancer-
             chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.

         13. Participant had a tumor in the bladder diverticulum.

         14. Participant had a history of interstitial cystitis.

         15. Participant was pregnant or breast-feeding.