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

NCT03224182 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: SPI-QAP-306
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence

  Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.

  From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 years)

Secondary Outcomes (3)

• 2-Year Recurrence Rate

  2 years

• Time to Disease Progression

  From randomization to first disease progression (up to 2.1 years)

• Number of Participants With Treatment-emergent Adverse Event (TEAE), Treatment-related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, TEAEs of Special Interest, and Death

  Up to 2.1 years

Study Arms (2)

Qapzola

EXPERIMENTAL

Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.

Drug: Qapzola

Placebo

PLACEBO COMPARATOR

Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.

Drug: Placebo

Interventions

Qapzola DRUG

Qapzola administered by the intravesical route.

Qapzola

Placebo DRUG

Qapzole-matching placebo administered by the intravesical route.

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.
• Participant was at least 18 years of age and \<90 years of age at the time Informed Consent is signed.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).
• Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.
• 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.
• 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.
• 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.
• 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.
• Participant had a hemoglobin value \<10 grams per deciliter (g/dL) at Screening.
• Participant had confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral).
• 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.
• Participant had received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.
• Participant had a tumor in the bladder diverticulum.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

The study was terminated as per Sponsor's decision.

Results Point of Contact

• Title: Shanta Chawla
• Organization: Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

shanta.chawla@sppirx.com

(949) 788-6700

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk NMIBC.

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: July 21, 2017
• Study Start: August 4, 2017
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)