Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT01410565. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.
Study identification
- NCT ID
- NCT01410565
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2011 (Type not available)
- Primary completion
- Mar 2014 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Dec 13, 2016
2011 – 2014
United States locations
- U.S. sites
- 28
- U.S. states
- 20
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Urologic Associates | Glendale | Arizona | 85308 | — |
| Precision Trials, LLC | Phoenix | Arizona | 85032 | — |
| South Orange County Medical Research Center | Laguna Woods | California | 92653 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Connecticut Clinical Research Center | Middlebury | Connecticut | 06762 | — |
| Urology Enterprises | Marietta | Georgia | 30060 | — |
| North Idaho Urology | Coeur d'Alene | Idaho | 83814 | — |
| Idaho Urologic Institute, P.A. | Meridian | Idaho | 83642 | — |
| Northeast Indiana Research, LLC | Fort Wayne | Indiana | 46825 | — |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | — |
| Anne Arundel Urology | Annapolis | Maryland | 21401 | — |
| Spectrum Health Medical Group | Grand Rapids | Michigan | 49546 | — |
| University of Minnesota | Minneapolis | Minnesota | 55418 | — |
| Five Valleys Urology | Missoula | Montana | 59802 | — |
| Delaware Valley Urology, LLC - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Delaware Valley Urology, LLC-Westampton | Woodlane | New Jersey | 08060 | — |
| University Urology Associates | New York | New York | 10016 | — |
| Urology Associates of Rochester, LLC | Rochester | New York | 14618 | — |
| TriState Urologic Services PSC, Inc. | Cincinnati | Ohio | 45212 | — |
| Urologic Consultants of Southeastern Pennsylvania, LLP | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Urology Health Specialists | Bryn Mawr | Pennsylvania | 19010 | — |
| Urological Associates of Lancaster | Lancaster | Pennsylvania | 17604 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates of South Texas | McAllen | Texas | 78503 | — |
| Urology of Virginia, PC | Virginia Beach | Virginia | 23454 | — |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | — |
| Integrity Medical Research, LLC | Mountlake Terrace | Washington | 98043 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01410565, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01410565 live on ClinicalTrials.gov.