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

NCT01648010 | Completed

• 2 other identifiers: TAS-4M-PR-H-127-1HTA 5972
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma of Urinary Bladder, Invasive

Keywords

Non Muscle Invasive Bladder Cancer; Carcinoma of urinary bladder, invasive; Intravesical instillation; Mitomycin C; Hydrogel; Reverse thermal gelation; Drug retention; radical cystectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.

  6 hours

Study Arms (2)

TC-3 gel

EXPERIMENTAL

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

Device: TC-3 gel

MMC- gel

EXPERIMENTAL

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

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

Interventions

TC-3 gel DEVICE

One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.

TC-3 gel

TC-3 gel mixed with Mitomycin C (MMC) DEVICE

One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter

Also known as: MMC Gel

MMC- gel

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Patients with bladder cancer designated to undergo Radical Cystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (3)

Barzilai Hospital

Ashkelon, Israel

Location

Wolfson

Holon, Israel

Location

Beilinson

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Michal Jeshurun, MD

  UroGen Pharma Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 24, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2012-12

Locations

IL (3)