Status:
RECRUITING
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
Lead Sponsor:
University of British Columbia
Conditions:
Urothelial Carcinoma of the Renal Pelvis and Ureter
Transitional Cell Cancer of the Renal Pelvis and Ureter
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carc...
Detailed Description
This study is a prospective, multicenter, single-arm, open-label clinical trial assessing the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to chemo...
Eligibility Criteria
Inclusion
- Adult (≥ 18 years) male or female
- Primary or recurrent low-grade (LG), noninvasive (Ta) Upper Tract Urothelial Carcinoma (UTUC) in the renal pelvis, infundibulum, and/or calyces, based on ureteroscopy, biopsy and cytology performed within 8 weeks prior to the Screening Visit
- At least 1 measurable papillary tumor measuring 5-15 mm
- Low grade tumor(s) in the ipsilateral ureter. Every attempt should be made to ablate this tumor completely, but residual ipsilateral ureteral tumor is not an exclusion criterion.
- Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy
- A life expectancy of greater than 12 months
- No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis
- Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visit and must use two acceptable contraceptives methods until six months post-treatment
- All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation
Exclusion
- Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1
- Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception
- Unresolved infection requiring active treatment with systemic antimicrobial drugs
- History of high-grade non-muscle invasive bladder cancer within the past 6 months
- History of muscle-invasive bladder cancer during the past 2 years
- Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial
- Urinary obstruction in the ipsilateral Upper Urinary Tract (UUT)
- Any contraindicated to gemcitabine or sensitivity to gemcitabine or any of the ST-02 ingredients
- Currently receiving another investigational agent or involved in a clinical trial with an investigational product within the past 30 days prior to Visit 1
- Active hepatitis B (chronic or acute) or active hepatitis C infection
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06124976
Start Date
June 19 2024
End Date
April 1 2026
Last Update
September 15 2025
Active Locations (4)
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1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
2
Men's Health Clinic
Winnipeg, Manitoba, Canada, R3P 2S8
3
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
4
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada