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
Drug: cis-UCA solution
Drug: cis-UCA solution
Drug: cis-UCA solution
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Full eligibility criteria for NCT01458847
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Informed consent obtained prior to any screening procedures
Patients with primary or recurrent non-muscle invasive bladder cancer
The patient is eligible for intravesical instillation
Age 18-80 years
WHO performance status 0-2
Body weight at least 50 kg for males and 45 kg for females; body mass index (BMI) 18-35 kg/m2
Diagnostic cystoscopy performed within 30 days prior to screening visit
Negative pregnancy test (premenopausal female patients) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the cis-UCA dose oPremenopausal female volunteers should be either surgically sterile or using a reliable contraception method: intrauterine device
(hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner
(surgical vasectomy) oPatients with no current heterosexual relationship may be included according to the judgment of the Investigator oIf menopause occurred 2 years ago at the minimum, no contraception is required for female participants, nor pregnancy tests oReliable contraception for male patients is concordant with above listed methods for females, as applicable
Acceptable liver function, renal function and hematological status at screening
Urinalysis showing no clinically significant abnormalities except those attributable for bladder cancer
Previously diagnosed bladder fibrosis
Total bladder capacity estimated by cystoscopy to be less that 150 ml
Urinary incontinence of that severity that according to the opinion of the Urologist/Investigator would compromise the ability of the patient to retain the study drug intravesical instillation for one hour
Severe irritative voiding symptoms, such as urgency, frequency and nocturia that could compromise protocol objectives in the opinion of the Urologist/Investigator
Serious disease (e.g., hydronephrosis, renal or liver failure or other condition) that could compromise protocol objectives in the opinion of the Urologist/Investigator
Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection
Previous treatment with radiotherapy, or systemic chemotherapy.
Intravesical instillation(s) within 6 months with BCG or cytostatic agents
Known allergy to cis-UCA-instillation solution (see Section 5.1 for excipients).
Having participated in a clinical study with cis-UCA previously
Known any serious immunodeficiency condition
Donation of blood or participation in another drug study within 60 days (males) or 90 days (females) before the intravesical instillation in this study
Any clinically significant laboratory test result (including positive tests for HIV and hepatitis B or C) according to Investigator/Urologist
Excessive use of alcohol (on average more than 24 units per week for males, and more that 16 units per weeks for females; unit = 4 cl spirits or equivalent)
Clinically significant illness (except bladder cancer) within 30 days before the screening visit or any other condition, such as vesicourethral reflux (VUR), or complicated urinary stone disease that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the patient
Regular use of urine alkalinizing agents/drugs (e.g., acetazolamide, calcium phosphates, aluminium hydroxide, sodium bicarbonate, sodium carbonate, sodium citrate, potassium citrate) that might interfere with the evaluation of the study results
Unwillingness or doubtful capacity to comply with the protocol
Doubtful availability, in the opinion of the Investigator, to complete the study
Poor peripheral venous access -
All locations for NCT01458847
Tampere University Hospital, Department of Urology
Tampere, Finland, 33520
Turku University Hospital, Department of Surgery, Division of Urology
Turku, Finland, 20520
View full eligibility
Tris trial is registered with FDA with number: NCT01458847. The sponsor of the trial is BioCis Pharma Ltd and it is looking for 12 volunteers for the current phase.
Official trial 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
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