CompletedNot Applicable

Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer

Israel7 participantsStarted 2011-11

Plain-language summary

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.

Who can participate

Age range45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.

Timeframe: 6 hours

Trial details

NCT IDNCT01648010

SponsorUroGen Pharma Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Carcinoma of Urinary Bladder, Invasive trials