Carcinoma of Urinary Bladder, InvasiveNCT01648010
Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer
A study testing TC-3 gel and TC-3 gel mixed with Mitomycin C (MMC) in people with Carcinoma of Urinary Bladder, Invasive, run by UroGen Pharma Ltd. at 3 sites in Israel.
Trial summary
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Carcinoma of Urinary Bladder, Invasive
- What is being tested?
- TC-3 gel and TC-3 gel mixed with Mitomycin C (MMC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2011to May 2013
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Patients with bladder cancer designated to undergo Radical Cystectomy
Who cannot join
- Sensitivity to MMC
- Acute urinary Tract Infection (UTI)
- Upper urinary tract obstruction.
- Patient received neoadjuvant treatment previous to Radical Cystectomy
- Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant
- Breastfeeding women
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
Read the detailed description
Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.
TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable gel (TC-3)for MMC retention in the urinary bladder.
Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder.
Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.
- Conditions
- Carcinoma of Urinary Bladder, Invasive
- Being tested
- TC-3 gel, TC-3 gel mixed with Mitomycin C (MMC)
- Keywords
- Non Muscle Invasive Bladder Cancer, Carcinoma of urinary bladder, invasive, Intravesical instillation, Mitomycin C, Hydrogel, Reverse thermal gelation, Drug retention, radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-3 gelDevice
One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
TC-3 gel mixed with Mitomycin C (MMC)Device
Also called MMC Gel
One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter
| Study group | Role | What they receive |
|---|---|---|
| TC-3 gel | Experimental | TC-3 gel group undergo intravesical instillation of the investigatory device Receives: Device: TC-3 gel |
| MMC- gel | Experimental | MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC Receives: Device: TC-3 gel mixed with Mitomycin C (MMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.
Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. During these six hours the MMC levels in urine and blood will be measured every hour and the Peak Plasma Concentration (Cmax)and Area under the plasma concentration versus time curve (AUC) will be calculated and compared to the standard toxicity level in patients treated with MMC in saline (standard of cure). In addition, patient tolerability to treatment will be evaluated.
Measured: 6 hours
Secondary outcomes (1)
Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.
Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. Local (bladder) tissue levels of MMC will be evaluated and compared to MMC levels detected following treatment with MMC in saline (standard of cure).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Urinary Bladder, InvasiveStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- UroGen Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michal Jeshurun, MD, Study director, UroGen Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648010
- Sponsor's protocol ID
- TAS-4M-PR-H-127-1
- Other IDs
- HTA 5972
- Status last verified
- Dec 2012
- First submitted
- 17 Jul 2012
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
- ClinicalTrials.gov ID
- NCT01648010
- Acronym / sponsor ID
- TAS-4M-PR-H-127-1
- Conditions
- Carcinoma of Urinary Bladder, Invasive
- Keywords
- Non Muscle Invasive Bladder Cancer, Carcinoma of urinary bladder, invasive, Intravesical instillation, Mitomycin C, Hydrogel, Reverse thermal gelation, Drug retention, radical cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- UroGen Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Jul 2012 (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 the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
Detailed description
Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.
TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable gel (TC-3)for MMC retention in the urinary bladder.
Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder.
Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TC-3 gel | Experimental | Device: TC-3 gelTC-3 gel group undergo intravesical instillation of the investigatory device |
| MMC- gel | Experimental | Device: TC-3 gel mixed with Mitomycin C (MMC)MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent form.
- Patients with bladder cancer designated to undergo Radical Cystectomy
Key exclusion criteria (6 listed)
- Sensitivity to MMC
- Acute urinary Tract Infection (UTI)
- Upper urinary tract obstruction.
- Patient received neoadjuvant treatment previous to Radical Cystectomy
- Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant
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 |
|---|---|---|
| TC-3 gelOne intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter. | Device | TC-3 gel |
| TC-3 gel mixed with Mitomycin C (MMC)Also: MMC GelOne intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter | Device | MMC- gel |
Primary outcome
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.
Time frame: 6 hours
Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. During these six hours the MMC levels in urine and blood will be measured every hour and the Peak Plasma Concentration (Cmax)and Area under the plasma concentration versus time curve (AUC) will be calculated and compared to the standard toxicity level in patients treated with MMC in saline (standard of cure). In addition, patient tolerability to treatment will be evaluated.
1 secondary outcome
Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.
Time frame: 6 hours
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 7 May 2013.
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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.
Michal Jeshurun, MD study director
UroGen Pharma Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC-3 gel and TC-3 gel mixed with Mitomycin C (MMC) in people with Carcinoma of Urinary Bladder, Invasive, run by UroGen Pharma Ltd. at 3 sites in Israel.
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 2 inclusion and 6 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 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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.
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?
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation. (time frame: 6 hours). 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 7 May 2013; AzTrials last refreshed its copy on 27 Oct 2026.