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

Not Applicable

Completed

• Conditions: Carcinoma of Urinary Bladder, Invasive
• Interventions: Device: TC-3 gel; Device: TC-3 gel mixed with Mitomycin C (MMC)

• Registration Number: NCT01648010
• Lead Sponsor: UroGen Pharma Ltd.

Brief 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.

Detailed Description

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.

TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable gel (TC-3)for MMC retention in the urinary bladder.

Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder.

Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Status Verified: 2012-12
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TC-3 gel	TC-3 gel	TC-3 gel group undergo intravesical instillation of the investigatory device
MMC- gel	TC-3 gel mixed with Mitomycin C (MMC)	MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC

Primary Outcome Measures

Name	Time	Method
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.	6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.	6 hours	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).

Trial Locations

Locations (3)

Wolfson; 🇮🇱 Holon, Israel

Barzilai Hospital; 🇮🇱 Ashkelon, Israel

Beilinson; 🇮🇱 Petah-Tikva, Israel