NCT01458847

Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer

A Single Dose, Dose-escalating, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Intravesical Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: BioCis Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive bladder cancer.

Detailed description

This is a single dose, dose-escalating, Phase I study to evaluate safety, tolerability and pharmacokinetics of intravesical cis-urocanic acid (cis-UCA) in patients with primary or recurrent non-muscle invasive bladder cancer. The primary objectives is to evaluate safety and tolerability of cis-UCA after a single intravesical instillation with escalating doses and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cis-UCA after a single intravesical instillation with escalating doses. The secondary objectives are to evaluate pharmacokinetics of cis-UCA after a single intravesical instillation with escalating doses, to obtain preliminary information on possible anti-tumor effects of cis-UCA by cystoscopy and histological evaluation after a single intravesical instillation with escalating doses, and to evaluate the effects of cis-UCA on different surrogate biochemical markers on tumor growth and differentiation after a single intravesical instillation with escalating doses. The key eligibility criteria are the following: Patients with primary or recurrent non-muscle invasive bladder cancer; eligible for intravesical treatment; age 18-80 years; WHO performance status 0-2; acceptable liver, renal and hematological function within 30 days prior to inclusion. At minimum 3 patients and at maximum 24 patients is planned to be included in the study. The fixed dose-escalation levels will be used. Up to three dose cohorts are planned to be included: * Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients * Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients * Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	cis-UCA solution	Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients
DRUG	cis-UCA solution	Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients
DRUG	cis-UCA solution	Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-10-25
• Last updated: 2012-11-12

Locations

2 sites across 1 country: Finland