A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)

• Status: Terminated
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Apaziquone

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.