EN3348 for treatment of Non-Muscule Invasive Bladder Cancer
Research type
Research Study
Full 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
IRAS ID
93566
Contact name
Owen Cole
Sponsor organisation
Endo Pharmaceuticals Inc.
Eudract number
2011-003496-11
Clinicaltrials.gov Identifier
Research summary
RThis is a Phase 3 international study investigating an experimental new drug EN3348 (MCC - myobacterial cell wall-DNA complex) in patients with non-muscle invasive bladder cancer resistant to standard therapy. The purpose of this study is to evaluate the safety and effectiveness of EN3348, how well investigational drug works in subjects with bladder cancer compared to mitomycin C. Mitomycin C has been used by doctors for many years to treat bladder cancer. EN3348 is made up of pieces of the cell wall (the material that holds a cell together) taken from a type of bacteria called mycobacteria, which is found naturally in the soil, on plants or in drinking water. The bacteria in EN3348/MCC are not alive. Several research studies have been completed in which EN3348/MCC has been given to subjects with bladder cancer. Results of these studies indicate that EN3348 may be effective for treatment of this type of cancer. In this study patients with bladder cancer will receive study treatment with either EN3348 or mitomycin C for up to 12 months. The study consists of 4 phases: Screening phase will last up to 6 weeks. During this phase patients will undergo test and procedures that will confirm that they can participate in the study. During Induction phase (6 weeks) patients will receive weekly instillations (administration through a catheter) of either EN3348 or mitomycin C for total of 6 doses. During the Maintenance phase (10 months) patients will receive monthly instillations of study drug for up to an additional 10 doses (up to Month 12). In addition, subjects will undergo disease assessments every 3 months, with a mandatory biopsy required at Month 6. Subjects will have completed the Maintenance Phase after completing the Month 12 instillation. During Follow up Phase (Up to approximately 24 months) all patients, regardless of number of study drug instillations received, will be monitored for disease progression and adverse events. 450 patients will participate in the study in North America, Europe and India.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
11/SC/0533
Date of REC Opinion
7 Feb 2012
REC opinion
Further Information Favourable Opinion