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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 is a Phase 3 study that was terminated before completion, run by Bioniche Life Sciences. The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01200992
The ClinicalTrials.gov registry entry for NCT01200992 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioniche Life Sciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EN3348 is the first listed.
NCT01200992 reports 0 study locations.
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.
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