Clinical trial · Interventional
Efficacy and Safety of UGN-101 in Recurrent Patients
A Phase 3b Multicenter Extension Trial Evaluating the Efficacy and Safety of UGN-101 (Mitomycin Gel) for Instillation on Ablation of Upper Urinary Tract Urothelial Carcinoma in Recurrent Patients From Trial TC-UT-03
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to projected low enrollment, it has decided not to move forward with the study.
Summary
Brief summary (as posted)
This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UGN-101 instillations | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UGN-101 instillations
- description
- The Mitomycin C (MMC) concentration of UGN-101 to be used in this trial will be 4 mg MMC per 1 mL of TC-3 gel, the maximum dose is 15ml. 3-6 once weekly intravesical instillations for the ablation treatment.
- interventionNames
- Drug: UGN-101 instillations
Primary outcomes (1)
- measure
- Complete response (CR) rate
- timeFrame
- An average of 11 weeks
- description
- Complete response defined dichotomously as "Success" if CR was confirmed at the end of the treatment period (PDE 2 Visit), and "Failure" otherwise.
Secondary outcomes (1)
- measure
- Long-term durability of complete response (CR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: 1. Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03). 2. Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma (up to 2 months before Visit 0). If there are tumors in both the kidney and the ureter, at least 1 biopsy should be taken from each location. 3. Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer. 4. Patients must have adequate organ and bone marrow function as determined by routine laboratory tests. 5. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis Main Exclusion Criteria: 1. Patient intends to be treated with systemic chemotherapy during the duration of the trial. 2. Patient with urinary obstruction. 3. Inability to deliver the IP to the UUT. 4. Patient has any other medical or mental condition(s) that make(s) their participation in the trial unadvisable in the opinion of the treating investigator. 5. Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.
References
Publications (0)
Data not yet available