Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UroGen Pharma Ltd.
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Patient is 18 years of age or older.

• Patient has signed Informed Consent Form and is willing and able to abide by the protocol.

• Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC.

• No active urinary tract infection as confirmed by urine culture.

• If the patient is a female of childbearing potential, she is using two acceptable & effective methods of contraception, until 6 months post treatment

• A negative serum pregnancy test at screening for female patient with childbearing potential

• If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation.

• If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable & effective methods of contraception until 6 months post treatment.

Exclusion Criteria:

• Tumor located in prostatic urethra (for male patient) or in the bladder diverticulum.

• Prior or required pelvic radiotherapy.

• Systemic chemotherapy within 1 year prior the screening.

• Pregnant or breastfeeding female patient.

• Treatment of bladder cancer with BCG within the last 12 months prior to screening visit . Exception: For patient that had BCG treatment within 6-12 months prior to screening visit and are not symptomatic, the patient may enroll at the investigator discretion.

• Treatment (full course) with intravesical chemotherapy within the 3 months, prior to screening visit.

• Contraindication to MMC treatment as per investigator determination, or known sensitivity to MMC or TC-3 ingredients.

• The patient has a known current urinary retention which requires intermittent catheterization to empty the bladder.

• The patient has a bleeding disorder or a screening platelet count <100X109/L.

• The patient has screening hemoglobin <10g/dL OR white blood cells < 4000 mm3.

• GFR<30

• Hepatic values exceeding 2 times the upper normal limit.

• The patient has a concurrent severe and/or uncontrolled medical condition (e.g., uncontrolled diabetes, compensated congestive heart failure [NYHA III and over], myocardial infarction within 6 months of screening visit, unstable or uncontrolled hypertension or an active uncontrolled infection) or psychiatric disease, which could compromise participation, compliance with scheduled visits, and/or completion of the study in the opinion of the investigator.

• The patient has a documented severe vesico-ureteral reflux or has an in-dwelling ureteral stent.

• The patient participated in an investigational interventional study within the past 90 days, prior to screening visit.