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Therapeutic Areas: Oncology | Nephrology | Family Medicine
Disease Category: Bladder Cancer
Location: United States, NY
EN3348 As Compared With Mitomycin C in the Treatment of BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
This is a phase 3 , randomized, multicenter study designed to evaluate the efficacy and safety of EN3348 as compared to Mitomycin C in subjects with BCG recurrent or refractory non muscle invasive bladder cancer. The study is divided into four phases with participation lasting about three years.
Patient Inclusion Criteria:
- 1. 18 years of age and older.
- 2. Have either BCG recurrent or refractory non muscle invasive bladder cancer.
- 3. Available for the duration of the study (approximately 36 months).
Patient Exclusion Criteria:
- 1. Current or previous history of muscle invasive bladder tumors.
- 2. Current or previous history of lymph node positive or metastatic bladder cancer.
- 3. Currently receiving systemic anti-cancer therapy.
- 4. Current or prior history of pelvic external beam radiotherapy.
- 5. current or prior history of systemic lupus.
- 6. Current or history of documented or suspected malignancy of any organ system, daignosed, treated or untreated, within the past 5 years.
Monica Johnson, RN, Research Coordinator
The Arthur Smith Institute for Urology
450 Lakeville Road, Suite M41
New Hyde Park, NY 11040
Phone: 516 734-8515
Fax: 516 734-8535
If you would like to learn more about participating in this study, please send an email message using the form below.
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