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

NCT02307487 | Completed Phase 2 DMC

• 1 other identifier: TC-BC-10
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bladder Cancer; Neoplasms; Urinary Bladder Diseases; Urologic Diseases

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

Outcome Measures

Primary Outcomes (4)

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  6 weeks

Secondary Outcomes (4)

• Rates of all adverse events or clinically relevant physical examination

  15 months

• Vital signs and laboratory findings

  15 months

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

  15 months

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

  15 months

Other Outcomes (2)

• Rate of patients with Complete Response (CR) to treatment

  8-10 weeks post treatment

• Rate of patients with durable Complete Response (CR) to treatment

  3, 6, 9 and 12 months post PDE visit

Study Arms (6)

Cohort A2

EXPERIMENTAL

120 mg MMC in 90ml gel

Drug: 120 mg MMC in 90ml gel

Cohort B2

EXPERIMENTAL

140 mg MMC in 90ml gel

Drug: 140 mg MMC in 90ml gel

Cohort C2

EXPERIMENTAL

160 mg MMC in 90ml gel

Drug: 160 mg MMC in 90ml gel

Cohort A

EXPERIMENTAL

120 mg MMC in 60ml gel

Drug: 120 mg MMC in 60ml gel

Cohort B

EXPERIMENTAL

140 mg MMC in 60ml gel

Drug: 140 mg MMC in 60ml gel

Cohort C

EXPERIMENTAL

160 mg MMC in 60ml gel

Drug: 160 mg MMC in 60ml gel

Interventions

120 mg MMC in 90ml gel DRUG

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

Also known as: Mitomycin C

Cohort A2

140 mg MMC in 90ml gel DRUG

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

Also known as: Mitomycin C

Cohort B2

160 mg MMC in 90ml gel DRUG

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

Also known as: Mitomycin C

Cohort C2

120 mg MMC in 60ml gel DRUG

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

Also known as: Mitomycin C

Cohort A

140 mg MMC in 60ml gel DRUG

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

Also known as: Mitomycin C

Cohort B

160 mg MMC in 60ml gel DRUG

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

Also known as: Mitomycin C

Cohort C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (2)

Wolfson Medical Center of Holon, Department of Urology

Holon, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (1)

• 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.

  PMID: 41074972 DERIVED

Related Links

• UroGen pharma official website

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Non-Muscle Invasive Bladder Neoplasms; Urologic Neoplasms

Interventions

Gels; Mitomycin

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ifat Klein, PhD

  UroGen Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

IL (2)