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

NCT01458847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-11-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Tampere University Hospital

    collaborator OTHER

  • FinnMedi Oy

    collaborator INDUSTRY

  • BioCis Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Juha Peltonen, MD · CRST (Clinical Research Services Turku)

  • Liisa Pylkkänen, MD, PhD · BioCis Pharma Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458847 on ClinicalTrials.gov