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

NCT03224182 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-09-28

Study results available
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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

Interventions

DRUG

Qapzola

Qapzola administered by the intravesical route.

DRUG

Placebo

Qapzole-matching placebo administered by the intravesical route.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Shanta Chawla, MD · Spectrum Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2019-09-26
Completion
2019-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03224182 on ClinicalTrials.gov