Clinical trial · Interventional
Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically in NMIBC Patients
Evaluation of the Clinical Response of Mitomycin-C (MMC) Embedded in Hydrogel (TC-3) in Comparison to Mitomycin C in Saline, When Administered Intravesically, Pre-TURBT in Non Muscle Invasive Bladder Cancer (NMIBC) Patients. Muscle Invasive Bladder Cancer (NMIBC) Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of ureters 6 hr post instillation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Urinary Bladder Diseases | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
| Urologic Diseases | — | UNRESOLVED | — |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 40 mg MMC in 40 mL TC-3. | Device | — | UNRESOLVED |
| 80 mg MMC in 40 mL TC-3. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 40 mg MMC in 40 mL TC-3.
- description
- TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 40 ml of TC-3 gel mixed with 40 mg MMC will be instilled using catheter.
- interventionNames
- Device: 40 mg MMC in 40 mL TC-3.
- type
- EXPERIMENTAL
- label
- 80 mg MMC in 40 mL TC-3.
- description
- TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 40 ml of TC-3 gel mixed with 80 mg MMC will be instilled using catheter.
- interventionNames
- Device: 80 mg MMC in 40 mL TC-3.
Primary outcomes (6)
- measure
- Subject's degree of response at 2-4 weeks post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion criteria: 1. Single or multiple tumors (n≤7) 2. Recurrent or Naive tumor. 3. No prior history of T1 and/or Tis 4. At least one tumor \>1mm. 5. Largest tumor diameter ≤ 30mm 6. Cystoscopic appearance of papillary Low or high grade tumor Main Exclusion Criteria: 1. Carcinoma In Situ (CIS) 2. Over 7 lesions 3. Lesion is larger than 30mm in diameter 4. Cystoscopic appearance suspicious for Tis 5. Tumor located in prostatic urethra 6. Previous systemic chemotherapy or pelvic radiotherapy.
References
Publications (0)
Data not yet available