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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Neoplasm, Intravesical Drug Administration, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ, Mycobacterium

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Trial Information

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


Inclusion Criteria:



- Is 18 years of age and older at time of consent signing

- Have either BCG recurrent or refractory NMIBC:

- 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

- A full induction course of BCG is defined as at least 5 out of 6 total
expected instillations of BCG within a period of 2 months, regardless of
dose strength

- Have histologically confirmed NMIBC (according to 2004 WHO classification) within 8
weeks prior to randomization

- High grade Ta papillary lesion(s)

- High or low grade T1 papillary lesion(s)(biopsy sample must include evidence of
muscularis propria)

- CIS, with or without Ta or T1 papillary tumor(s) of any grade

- Have had all visible papillary and resectable CIS lesion(s) removed by TURBT within 8
weeks prior to randomization

- Available for the duration of the study including follow-up (approximately 36 months)

- Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or
less

- Have no evidence of urothelial carcinoma involving the upper urinary tract or the
urethra (confirmed by extravesical work up, which may include radiological imaging
and/or biopsy) within 6 months of randomization:

- If previous work up occurred more than 6 months from randomization, extravesical
work up must be repeated prior to randomization in order to determine
eligibility

- Subjects (male and female) of child-bearing potential (including female subjects who
are post-menopausal for less than 1 year) must be willing to practice effective
contraception (as defined by the Investigator) during the study and be willing and
able to continue contraception for 30 days after their last dose of study treatment

- Is able to understand and give written informed consent

Exclusion Criteria:

- Current or previous history of muscle invasive bladder tumors

- Current or previous history of lymph node positive and/or metastatic bladder cancer

- Current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure
undifferentiated carcinoma of the bladder

- Currently receiving systemic cancer therapy (cytotoxic/cytostatic or immunotherapy)

- Currently receiving treatment with a prohibited therapy

- Current or prior history of systemic lupus erythematosus

- Systemic immunotherapy within 6 months of randomization

- Treatment with an investigational agent within 30 days or 5 half lives from
randomization, whichever is longer

- Prior treatment with an intravesical chemotherapeutic agent within 3 months of
randomization except for single perioperative dose of chemotherapy immediately
post-TURBT

- Prior treatment with EN3348 (MCC) or any other mycobacterial cell wall composition or
formulation

- Refractory to mitomycin C (failure to achieve tumor-free status following minimum of
a 6 week induction course of mitomycin C)

- Contraindication to mitomycin C

- Untreated urinary tract or bladder infection

- ANC <1000/┬ÁL and hemoglobin <10 g/dL

- Known cardiovascular disease such as myocardial infarction within the past 3 months,
unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or
uncontrolled cardiac arrhythmia

- Female subjects who are pregnant or lactating

- Congenital or acquired immune deficiency

- Have current or history of documented or suspected malignancy of any organ system
(diagnosed, treated or untreated) within the past 5 years (with the exception of
localized transitional cell carcinoma of the ureter treated with ureterectomy or
nephroureterectomy, adequately treated basal cell or squamous cell carcinoma of the
skin or asymptomatic non-metastatic prostate cancer either previously successfully
treated or currently under active surveillance or receiving hormone therapy only)

- Bladder contracture or history of an inability to retain the instillate for a minimum
of 1 hour, even with premedication

- Inability to tolerate intravesical administration or intravesical surgical
manipulation (cystoscopy or biopsy)

- Clinically significant active infections

- Any medical or psychiatric condition which, in the opinion of the investigator, would
preclude the participant from adhering to the protocol or completing the trial per
protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

EN3348-303

NCT ID:

NCT01200992

Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Bladder Neoplasm
  • Intravesical Drug Administration
  • Neoplasm Recurrence, Local
  • Transitional Cell, Carcinoma
  • Carcinoma in Situ
  • Mycobacterium
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Neoplasms by Site
  • Urinary Bladder Diseases
  • Urologic Diseases
  • Mycobacterial cell wall DNA complex
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Mycobacterium Infections
  • Neoplasm Recurrence, Local
  • Recurrence

Name

Location

University of Connecticut Health Center Farmington, Connecticut  06360-7106
Montefiore Medical Center Bronx, New York  10467-2490
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Michigan Institute of Urology Detroit, Michigan  48236
Urology Associates of North Texas Arlington, Texas  76015
University of Pittsburgh Pittsburgh, Pennsylvania  15261
University of Maryland Baltimore, Maryland  21201
University of Chicago Chicago, Illinois  60637
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
AccuMed Research Associates Garden City, New York  11530
Northeast Indiana Research, LLC Fort Wayne, Indiana  46825-1675
Advanced Research Institute, Inc. New Port Richey, Florida  34652
Triangle Urological Group Pittsburgh, Pennsylvania  15212
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Columbia University Medical Center New York, New York  10032
Arizona Urologic Specialists Tucson, Arizona  85712
West Coast Clinical Research Tarzana, California  91356
Urology Associates Denver, Colorado  80210
Urology Associates of South Texas McAllen, Texas  78503
San Diego Clinical Trials San Diego, California  92120
Chesapeake Urology Research Associates Towson, Maryland  21204
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
The Urology Center of Colorado Denver, Colorado  80211
Kansas City Urology Care, P.A. Overland Park, Kansas  66211
TriState Urologic Services PSC, Inc. Cincinnati, Ohio  45212
Urologic Consultants of SE PA Bala Cynwyd, Pennsylvania  19004
Urology Clinics of North Texas, PA Dallas, Texas  75231
Pharma Resource East Providence, Rhode Island  02915
Deaconess Clinic, Inc. Evansville, Indiana  47713
BCG Oncology, PC Phoenix, Arizona  85032
Grove Hill Medical Center New Britain, Connecticut  
Virginia Urology Richmond, Virginia  23235
American Institute of Research Whittier, California  90603
Urology Specialists of Southern California - Burbank Burbank, California  91505
Urology Specialist of Southern California - Encino Encino, California  91436
Urology Specialists of Southern California - Torrance Torrance, California  90505
Genitourinary Surgical Consultants, PC Denver, Colorado  80220
Florida Urological Associates, PA Coral Springs, Florida  33071
Urological Research Network Hialeah, Florida  33016
Urology Health Team, PLLC Ocala, Florida  34474
Northwestern Medicine Chicago, Illinois  60611
Corbin Clinical Resources Cumberland, Maryland  21502
Myron I. Murdock, MD, LLC Greenbelt, Maryland  20770
Bay State Urologists Watertown, Massachusetts  02472
Delaware Valley Urology, LLC Burlington Mt. Laurel, New Jersey  08054
Delaware Valley Urology Sewell, New Jersey  08080
The Capital Region Medical Research Foundation, Inc. Albany, New York  12208
Premier Medical Group of the Hudson Valley Poughkeepsie, New York  12601
Columbus Urology Columbus, Ohio  43220
Unison Clinical Research Toledo, Ohio  43615
Parkhurst Research Organization, LLC Bethany, Oklahoma  73008
Urology Health Specialists, LLC Bryn Mawr, Pennsylvania  19010
Ilumina Clinical Associates Indiana, Pennsylvania  15701
Mount Nittany Physician Group State College, Pennsylvania  16801