Non-muscle Invasive Bladder CancerPhase 1NCT01458847
Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer
A Phase 1 study testing cis-UCA solution in people with Non-muscle Invasive Bladder Cancer, run by BioCis Pharma Ltd at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- cis-UCA solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFinland
- Study dates
- Oct 2009to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 -
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere University Hospital, Department of Urology
Tampere, 33520
Turku University Hospital, Department of Surgery, Division of Urology
Turku, 20520
About this study
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.
Read the 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
- Being tested
- cis-UCA solution
- Keywords
- bladder cancer, cis-urocanic acid, primary, recurrent, non-muscle
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cis-UCA solutionDrug
Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients
cis-UCA solutionDrug
Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients
cis-UCA solutionDrug
Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients
| Study group | Role | What they receive |
|---|---|---|
| Cohort I: 2% cis-UCA solution (50 ml) | Experimental | Not described Receives: Drug: cis-UCA solution |
| Cohort II: 4% cis-UCA solution (50 ml) | Experimental | Not described Receives: Drug: cis-UCA solution |
| Cohort III: 6% cis-UCA solution (50 ml) | Experimental | Not described Receives: Drug: cis-UCA solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder-related AEs
Measured: until resection, max 2 months
Urinalysis
Measured: 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
Measured: participants will be followed until resection, an expected average of 2 months
Secondary outcomes (2)
Area Under Curve (AUC)
Measured: Predose, 30 min, 45 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, and 24 h post-dose
Efficacy
Change in tumor size from baseline by cystoscopy, change in tumor proliferation marker Ki-67 by immunohistochemistry, change in caspase-3 expression by immunohistochemistry
Measured: Predose, up to 2 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCis Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital, Tampere University Hospital, FinnMedi Oy
- Responsible party
- Sponsor
- Investigators
- Juha Peltonen, MD, Principal investigator, CRST (Clinical Research Services Turku)Liisa Pylkkänen, MD, PhD, Study chair, BioCis Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458847
- Sponsor's protocol ID
- CL08003
- Other IDs
- 2009-011287-11, 2009
- Status last verified
- Nov 2012
- First submitted
- 4 Oct 2011
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01458847
- Acronym / sponsor ID
- CL08003
- Conditions
- Non-muscle Invasive Bladder Cancer
- Keywords
- bladder cancer, cis-urocanic acid, primary, recurrent, non-muscle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BioCis Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital, Tampere University Hospital, FinnMedi Oy
- Study start
- Oct 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cis-UCA solutionCohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients | Drug | Cohort I: 2% cis-UCA solution (50 ml) |
| cis-UCA solutionCohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients | Drug | Cohort II: 4% cis-UCA solution (50 ml) |
| cis-UCA solutionCohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients | Drug | Cohort III: 6% cis-UCA solution (50 ml) |
Primary outcome
Bladder-related AEs
Time frame: until resection, max 2 months
Urinalysis
Time frame: 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
Time frame: participants will be followed until resection, an expected average of 2 months
cystoscopy descriptions
2 secondary outcomes
Area Under Curve (AUC)
Time frame: Predose, 30 min, 45 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, and 24 h post-dose
Efficacy
Time frame: Predose, up to 2 months post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha Peltonen, MD principal investigator
CRST (Clinical Research Services Turku)
Liisa Pylkkänen, MD, PhD study chair
BioCis Pharma Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cis-UCA solution in people with Non-muscle Invasive Bladder Cancer, run by BioCis Pharma Ltd at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder-related AEs (time frame: until resection, max 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.