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NCT00406068 · ClinicalTrials.gov registry record · Phase 2
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
A Phase 2 study of Bladder Neoplasms, sponsored by Bioniche Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT00406068 is a Phase 2 study of Bladder Neoplasms that has completed, run by Bioniche Life Sciences. The registered enrollment target is 129 participants, below the 1,869-participant average among 3 other Bladder Neoplasms trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00406068, a Phase 2 study of Bladder Neoplasms, has completed, sponsored by Bioniche Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).
Conditions Studied
Interventions
- DRUG Mycobacterial cell wall-DNA complex
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Centre - New York
- Hudson Valley Urology - Poughkeepsie
- University of Rochester Medical Center - Rochester
Texas
- Urology Clinics of North Texas, P.A. - Dallas
- M.D. Anderson Cancer Center - Houston
- Urology San Antonio Research, PA - San Antonio
Florida
- University of Miami School of Medicine - Miami
- Winter Park Urology Associates P.A. - Orlando
Maryland
- Johns Hopkins University - Baltimore
- Chesapeake Urology Research Associates - Towson
Arizona
- BCG Oncology - Phoenix
California
- San Diego Clinical Trials - San Diego
Connecticut
- Connecticut Urological Research at Grove Hill - New Britain
Illinois
- The University of Chicago Hospitals - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00406068
The ClinicalTrials.gov registry entry for NCT00406068 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,869-participant average among 3 other Bladder Neoplasms trials with a reported enrollment target (93% lower). The listed sponsor is Bioniche Life Sciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Mycobacterial cell wall-DNA complex is the first listed.
NCT00406068 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT00406068 about?
NCT00406068 is a clinical study titled "Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer". The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refracto...
What is the current status of trial NCT00406068?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2006-11. Estimated completion is 2011-07.
What conditions does trial NCT00406068 study?
This clinical trial studies the following conditions: Bladder Neoplasms.
What interventions are being tested in trial NCT00406068?
The interventions under investigation include: Mycobacterial cell wall-DNA complex (DRUG).
Who is sponsoring clinical trial NCT00406068?
This trial is sponsored by Bioniche Life Sciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00406068 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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