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Bladder CancerPhase 2NCT02307487

Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

A Phase 2 study testing 120 mg MMC in 90ml gel, 140 mg MMC in 90ml gel and 160 mg MMC in 90ml gel in people with Bladder Cancer and Neoplasms, run by UroGen Pharma Ltd. at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
120 mg MMC in 90ml gel, 140 mg MMC in 90ml gel and 160 mg MMC in 90ml gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesIsrael
Study dates
Dec 2014to Jun 2017
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is 18 years of age or older.
  • Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
  • Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC.
  • No active urinary tract infection as confirmed by urine culture.
  • If the patient is a female of childbearing potential, she is using two acceptable \& effective methods of contraception, until 6 months post treatment
  • A negative serum pregnancy test at screening for female patient with childbearing potential
  • If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation.
  • If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable \& effective methods of contraception until 6 months post treatment.

Who cannot join

  • Tumor located in prostatic urethra (for male patient) or in the bladder diverticulum.
  • Prior or required pelvic radiotherapy.
  • Systemic chemotherapy within 1 year prior the screening.
  • Pregnant or breastfeeding female patient.
  • Treatment of bladder cancer with BCG within the last 12 months prior to screening visit . Exception: For patient that had BCG treatment within 6-12 months prior to screening visit and are not symptomatic, the patient may enroll at the investigator discretion.
  • Treatment (full course) with intravesical chemotherapy within the 3 months, prior to screening visit.
Show all 15Show fewer
  • Contraindication to MMC treatment as per investigator determination, or known sensitivity to MMC or TC-3 ingredients.
  • The patient has a known current urinary retention which requires intermittent catheterization to empty the bladder.
  • The patient has a bleeding disorder or a screening platelet count <100X109/L.
  • The patient has screening hemoglobin <10g/dL OR white blood cells < 4000 mm3.
  • GFR<30
  • Hepatic values exceeding 2 times the upper normal limit.
  • The patient has a concurrent severe and/or uncontrolled medical condition (e.g., uncontrolled diabetes, compensated congestive heart failure [NYHA III and over], myocardial infarction within 6 months of screening visit, unstable or uncontrolled hypertension or an active uncontrolled infection) or psychiatric disease, which could compromise participation, compliance with scheduled visits, and/or completion of the study in the opinion of the investigator.
  • The patient has a documented severe vesico-ureteral reflux or has an in-dwelling ureteral stent.
  • The patient participated in an investigational interventional study within the past 90 days, prior to screening visit.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Wolfson Medical Center of Holon, Department of Urology

    Holon

  • Meir Medical Center

    Kfar Saba

Other trials in Israel

About this study

Official title: Evaluation of the Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel Mixed With Mitomycin C (MMC) in Non-muscle Invasive Bladder Cancer (NMIBC) Patients

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

Read the detailed description

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients. A total of 10 patients will be treated in the first cohort with 120mg MMC-TC-3 Gel unless DLT is reached in more than 1/3 of the patients in the cohort. The next cohorts will have 3 patients/cohort, each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations. Since data is already available for 40 and 80 mg MMC in TC-3 gel, the initial cohort is 120mg MMC mixed with of 60 mL TC-3. Subsequent cohorts will be given dose levels of 140mg \& 160mg MMC mixed with 60 mL TC-3. Thus, if 160mg MMC mixed in 60ml TC-3 will be found to be safe and tolerable, no higher doses will be further explored at this stage.

If 120 mg MMC in 60 ml TC-gel (2 mg/ml) is found to be intolerable, higher concentrations will not be tested. Instead, a dose of 120 mg in 90 cc TC gel and a subsequent doses of 140 and 160 mg MMC in 90 cc TC gel will be tested in the same dose escalating manner. This will allow testing similar doses at lower concentrations (up to 1.78 mg/ml) but with a longer dwell time due to the larger volume of TC-gel.

Dose escalation is to be halted when the maximum tolerated dose (MTD) will be reached; MTD is defined as one dose level below which dose limited toxicity (DLT) is Any adverse event (AE) related to TC-3+MMC and qualified per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as grade 3 or 4 will be evaluated by board of 2 independent physicians to determine if it qualifies as DLT based on the known safety profile of MMC. If the NCI grade will not apply, the adverse event to be graded as mild, moderate, or severe.

If one of the three patients in a cohort experienced a DLT, three more patients will be added to the cohort for AE confirmation, only if 3 patients from the given cohort will experienced DLT, the MTD will be reached If no further DLTs are observed in the cohort, the three patients will be enrolled in the next successive cohort.

Being tested
120 mg MMC in 90ml gel, 140 mg MMC in 90ml gel, 160 mg MMC in 90ml gel, 120 mg MMC in 60ml gel, 140 mg MMC in 60ml gel
Keywords
TC-3 Gel, MMC, NMIBC, Non Muscle Invasive Bladder Cancer, Hydrogel Reverse thermal gelation, Drug retention, Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases
Medical subject headings
Urinary Bladder Neoplasms, Neoplasms, Urinary Bladder Diseases, Urologic Diseases, Non-Muscle Invasive Bladder Neoplasms, Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 120 mg MMC in 90ml gelDrug

    Also called Mitomycin C

    120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

  • 140 mg MMC in 90ml gelDrug

    Also called Mitomycin C

    140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

  • 160 mg MMC in 90ml gelDrug

    Also called Mitomycin C

    160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

  • 120 mg MMC in 60ml gelDrug

    Also called Mitomycin C

    120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

  • 140 mg MMC in 60ml gelDrug

    Also called Mitomycin C

    140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

  • 160 mg MMC in 60ml gelDrug

    Also called Mitomycin C

    160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

Study groups in NCT02307487
Study groupRoleWhat they receive
Cohort A2Experimental120 mg MMC in 90ml gel
Receives: Drug: 120 mg MMC in 90ml gel
Cohort B2Experimental140 mg MMC in 90ml gel
Receives: Drug: 140 mg MMC in 90ml gel
Cohort C2Experimental160 mg MMC in 90ml gel
Receives: Drug: 160 mg MMC in 90ml gel
Cohort AExperimental120 mg MMC in 60ml gel
Receives: Drug: 120 mg MMC in 60ml gel
Cohort BExperimental140 mg MMC in 60ml gel
Receives: Drug: 140 mg MMC in 60ml gel
Cohort CExperimental160 mg MMC in 60ml gel
Receives: Drug: 160 mg MMC in 60ml gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0

    Measured: 6 weeks

  2. Vital signs findings considered to be dose limiting according to the CTCAE V 4.0

    Measured: 6 weeks

  3. Clinical evaluation findings considered to be dose limiting according to the CTCAE V 4.0

    Measured: 6 weeks

  4. Lab results considered to be dose limiting according to the CTCAE V 4.0

    Measured: 6 weeks

Secondary outcomes (4)

  1. Rates of all adverse events or clinically relevant physical examination

    Measured: 15 months

  2. Vital signs and laboratory findings

    Measured: 15 months

  3. MMC maximum plasma concentration and concentration time curve during 6 hr post instillation

    Measured: 15 months

  4. Duration of MMC retention in the bladder as detected by urine MMC levels post instillation (6-7 hours)

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionApr 2016
  4. Study completionJun 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02307487
Sponsor's protocol ID
TC-BC-10
Status last verified
Jun 2017
First submitted
28 Oct 2014
Last updated
16 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Prasad SM, Louie MJ, Burger B, Tsurutis V, Ugwuoke N, Strauss-Ayali D. Pharmacokinetics of UGN-102, an investigational mitomycin-containing reverse thermal gel for the treatment of non-muscle invasive bladder cancer. Cancer Chemother Pharmacol. 2025 Oct 11;95(1):100. doi: 10.1007/s00280-025-04821-5.

    PubMed 41074972

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 120 mg MMC in 90ml gel, 140 mg MMC in 90ml gel and 160 mg MMC in 90ml gel in people with Bladder Cancer and Neoplasms, run by UroGen Pharma Ltd. at 2 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 8 inclusion and 15 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 16 Jun 2017. 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 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0 (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02307487, which also lists 1 linked publication.

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 16 Jun 2017.

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