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

NCT01458847 | Completed Phase 1 DMC

• 2 other identifiers: CL080032009-011287-11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Non-muscle Invasive Bladder Cancer

Keywords

bladder cancer; cis-urocanic acid; primary; recurrent; non-muscle

Outcome Measures

Primary Outcomes (3)

• Bladder-related AEs

  until resection, max 2 months

• Urinalysis

  participants will be followed until resection, an expected average of 2 months

• Evaluation of the appearance of normal bladder epithelium after the cis-UCA dose by cystoscopy during the planned surgical procedure

  cystoscopy descriptions

  participants will be followed until resection, an expected average of 2 months

Secondary Outcomes (2)

• Area Under Curve (AUC)

  Predose, 30 min, 45 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, and 24 h post-dose

• Efficacy

  Predose, up to 2 months post-dose

Study Arms (3)

Cohort I: 2% cis-UCA solution (50 ml)

EXPERIMENTAL

Drug: cis-UCA solution

Cohort II: 4% cis-UCA solution (50 ml)

EXPERIMENTAL

Drug: cis-UCA solution

Cohort III: 6% cis-UCA solution (50 ml)

EXPERIMENTAL

Drug: cis-UCA solution

Interventions

cis-UCA solution DRUG

Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients

Cohort I: 2% cis-UCA solution (50 ml)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCis Pharma Ltd: lead
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• FinnMedi Oy: collaborator

Study Sites (2)

Tampere University Hospital, Department of Urology

Tampere, 33520, Finland

Location

Turku University Hospital, Department of Surgery, Division of Urology

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juha Peltonen, MD

  CRST (Clinical Research Services Turku)

  PRINCIPAL INVESTIGATOR

• Liisa Pylkkänen, MD, PhD

  BioCis Pharma Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

FI (2)