Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01200992
Status:
TERMINATED
Last Update Posted:
2017-08-24
First Post:
2010-09-12
Brief Title:
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 RecurrentRefractory Non-muscle Invasive Bladder Cancer
Sponsor:
Bioniche Life Sciences Inc
Organization:
Bioniche Life Sciences Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBARC-RF
Brief 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 andor CIS at least 6 months from the start of a full induction course of BCG with or without maintenancere-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 maintenancere-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
Refractory disease is defined as evidence of persistent high grade bladder cancer Ta HG T1 andor CIS at least 6 months from the start of a full induction course of BCG with or without maintenancere-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 maintenancere-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None