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NCT01200992 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Bioniche Life Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT01200992: Clinical Trial Phase 3 study, sponsored by Bioniche Life Sciences.
NCT01200992 is a Phase 3 study that was terminated before completion, run by Bioniche Life Sciences. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200992, a Phase 3 study, was terminated before completion, sponsored by Bioniche Life Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.
Interventions
- BIOLOGICAL EN3348
- BIOLOGICAL Mitomycin C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
Why NCT01200992 stopped before completion
NCT01200992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which EN3348 is the first listed.
NCT01200992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01200992 about?
NCT01200992 is a clinical study titled "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". 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. ...
What is the current status of trial NCT01200992?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2010-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01200992?
The interventions under investigation include: EN3348 (BIOLOGICAL), Mitomycin C (BIOLOGICAL).
Who is sponsoring clinical trial NCT01200992?
This trial is sponsored by Bioniche Life Sciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01200992's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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