Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Urologic Neoplasms

Carcinoma in Situ

Mycobacterium Infections

Urologic Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Neoplasm Recurrence, Local

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Disease Attributes

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Mitomycins

Mitomycin

BCG Vaccine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

8 mg mixed with sterile water for injection for a total volume of 50mL

40 mg powder will be reconstituted with sterile water for injection to a total volume of 40 mL

Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12

EN3348

Mitomycin C

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.

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, 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

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.

Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.

Bioniche Life Sciences Inc.

8 mg mixed with sterile water for injection for a total volume of 50mL

Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)

40 mg mixed with sterile water for injection to a total volume of 40 mL

Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)

8 mg EN3348 mixed with water for injection for a total volume of 50mL

EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12

40 mg mitomycin C mixed with water for injection to a total volume of 40 mL

Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12

Total

Age, Continuous

Sex: Female, Male

Aline Hagerimana, MD, Senior Director Clinical Affairs

8 mg mixed with water for injection for a total volume of 50mL

Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)

40 mg mixed with water for injection to a total volume of 40 mL

Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)

The study was discontinued early. The number of subjects randomized at time of closure represented 18.7% of the planned enrollment of 450 subjects. Thus, the planned analysis as stated in the protocol was not performed. Only 2 subjects (5.1%) in the EN3348 arm and 4 subjects (8.9%) in the mitomycin C arm completed all planned doses.

Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.

Dysuria

Hematuria

Pollakiuria

Fatigue

Urinary tract infection

Diarrhea

Back pain

Nausea

Relevant safety data are presented in the Adverse Events and Serious Adverse Events Modules. Any clinically significant findings pertaining to other secondary outcomes such as vital signs, physical exams and laboratory test results would appear in these Modules as well. No statistical comparisons have been performed between the 2 treatment arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT01200992	Bladder Neoplas... Neoplasm Recurr... Transitional Ce... Carcinoma in Si... Mycobacterium	EN3348 Mitomycin C	18 Years -	Bioniche Life Sciences Inc.
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	NCT01200992	Bladder Neoplas... Neoplasm Recurr... Transitional Ce... Carcinoma in Si... Mycobacterium	EN3348 Mitomycin C	18 Years -	Bioniche Life Sciences Inc.

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