Non-muscle Invasive Bladder Cancer Clinical Trial
Official title:
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 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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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