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

UroGen Pharma

Status: Completed

Conditions: Carcinoma of Urinary Bladder, Invasive

Treatments: Device: TC-3 gel; Device: TC-3 gel mixed with Mitomycin C (MMC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01648010

HTA 5972 (Other Identifier)

TAS-4M-PR-H-127-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 2 patient groups

TC-3 gel

Experimental group

Description:

TC-3 gel group undergo intravesical instillation of the investigatory device

Treatment:

Device: TC-3 gel

MMC- gel

Experimental group

Description:

MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC

Treatment:

Device: TC-3 gel mixed with Mitomycin C (MMC)