Carcinoma of Urinary Bladder, Invasive Clinical Trial
Official title:
An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
Verified date | December 2012 |
Source | UroGen Pharma Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Israeli Ministry of Health |
Study type | Interventional |
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent form. - Patients with bladder cancer designated to undergo Radical Cystectomy Exclusion Criteria: - Sensitivity to MMC - Acute urinary Tract Infection (UTI) - Upper urinary tract obstruction. - Patient received neoadjuvant treatment previous to Radical Cystectomy - Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant - Breastfeeding women |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Israel | Barzilai Hospital | Ashkelon | |
Israel | Wolfson | Holon | |
Israel | Beilinson | Petah-Tikva |
Lead Sponsor | Collaborator |
---|---|
UroGen Pharma Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation. | Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. During these six hours the MMC levels in urine and blood will be measured every hour and the Peak Plasma Concentration (Cmax)and Area under the plasma concentration versus time curve (AUC) will be calculated and compared to the standard toxicity level in patients treated with MMC in saline (standard of cure). In addition, patient tolerability to treatment will be evaluated. | 6 hours | Yes |
Secondary | Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC. | Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. Local (bladder) tissue levels of MMC will be evaluated and compared to MMC levels detected following treatment with MMC in saline (standard of cure). | 6 hours | Yes |