Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT01200992. 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, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide. Subjects with either recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study. Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. Approximately 450 subjects will be randomized. The primary objective of this study is to evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance and Follow-Up and will be conducted over 3 years.
Study identification
- NCT ID
- NCT01200992
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 84 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
- Nov 2010 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Aug 24, 2017
2010 – 2013
United States locations
- U.S. sites
- 56
- U.S. states
- 22
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Clinical Research Center, LLC | Anchorage | Alaska | 99508 | — |
| BCG Oncology, PC | Phoenix | Arizona | 85032 | — |
| Arizona Urologic Specialists | Tucson | Arizona | 85712 | — |
| Urology Specialists of Southern California - Burbank | Burbank | California | 91505 | — |
| Urology Specialist of Southern California - Encino | Encino | California | 91436 | — |
| American Institute of Research | Los Angeles | California | 90017 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| West Coast Clinical Research | Tarzana | California | 91356 | — |
| Urology Specialists of Southern California - Torrance | Torrance | California | 90505 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Genitourinary Surgical Consultants, PC | Denver | Colorado | 80220 | — |
| Urology Associates | Englewood | Colorado | 80113 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| Grove Hill Medical Center | New Britain | Connecticut | 06052 | — |
| Florida Urological Associates, PA | Coral Springs | Florida | 33071 | — |
| Urological Research Network | Hialeah | Florida | 33016 | — |
| Urology Health Team, PLLC | Ocala | Florida | 34474 | — |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | — |
| Northwestern Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | — |
| Northeast Indiana Research, LLC | Fort Wayne | Indiana | 46825 | — |
| Kansas City Urology Care, P.A. | Overland Park | Kansas | 66211 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Chesapeake Urology Research Associates | Baltimore | Maryland | 21237 | — |
| Corbin Clinical Resources | Cumberland | Maryland | 21502 | — |
| Chesapeake Urology Research Associates | Glen Burnie | Maryland | 21061 | — |
| Myron I. Murdock, MD, LLC | Greenbelt | Maryland | 20770 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Bay State Urologists | Watertown | Massachusetts | 02472 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| Delaware Valley Urology, LLC Burlington | Mount Laurel | New Jersey | 08054 | — |
| Delaware Valley Urology | Voorhees Township | New Jersey | 08043 | — |
| The Capital Region Medical Research Foundation, Inc. | Albany | New York | 12208 | — |
| Accumed Research Associates | Garden City | New York | 11530 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| TriState Urologic Services PSC, Inc. | Cincinnati | Ohio | 45212 | — |
| Columbus Urology | Columbus | Ohio | 43220 | — |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | — |
| Unison Clinical Research | Toledo | Ohio | 43615 | — |
| Parkhurst Research Organization, LLC | Bethany | Oklahoma | 73008 | — |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Urology Health Specialists, LLC | Bryn Mawr | Pennsylvania | 19010 | — |
| Ilumina Clinical Associates | Indiana | Pennsylvania | 15701 | — |
| Triangle Urological Group | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Mount Nittany Physician Group | State College | Pennsylvania | 16801 | — |
| Pharma Resource | East Providence | Rhode Island | 02915 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Urology Associates of North Texas | Arlington | Texas | 76017 | — |
| Urology Clinics of North Texas, PA | Dallas | Texas | 75231 | — |
| Urology Associates of South Texas | McAllen | Texas | 78503 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01200992, 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 Aug 24, 2017 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01200992 live on ClinicalTrials.gov.