Status:
COMPLETED
Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients
Lead Sponsor:
UroGen Pharma Ltd.
Conditions:
Bladder Cancer
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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. A total of 10 patients will be t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02307487
Start Date
December 1 2014
End Date
June 1 2017
Last Update
June 16 2017
Active Locations (2)
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1
Wolfson Medical Center of Holon, Department of Urology
Holon, Israel
2
Meir Medical Center
Kfar Saba, Israel