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NCT03224182 · ClinicalTrials.gov registry record · Phase 3
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT03224182: Clinical Trial Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT03224182 is a Phase 3 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03224182, a Phase 3 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study 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)
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Qapzola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 3 |
Why NCT03224182 stopped before completion
NCT03224182 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03224182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03224182 about?
NCT03224182 is a clinical study titled "A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)". 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 ...
What is the current status of trial NCT03224182?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2017-08-04. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03224182?
The interventions under investigation include: Placebo (DRUG), Qapzola (DRUG).
Who is sponsoring clinical trial NCT03224182?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03224182's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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