Using ST-02 to treat low-grade upper tract urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of ST-02, a mucoadhesive gemcitabine suspension, for the treatment of low-grade upper tract urothelial carcinoma (UTUC). Participants with biopsy-confirmed low-grade tumors measuring 5 to 15 mm will receive weekly instillations of ST-02 for six weeks. The primary objective is to evaluate the complete response rate at three months post-treatment, monitored through ureteroscopy and cytology. If successful, patients will continue to receive maintenance treatments every three months for up to a year.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 (disease assessment URS) performed within 8 weeks prior to or during 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
* eGFR ≥10 mL/min; weekly creatinine monitoring recommended during treatment for participants with eGFR \<30 mL/min or a solitary functional kidney

Exclusion Criteria:

* Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1)
* 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 (D1)
* Active hepatitis B (chronic or acute) or active hepatitis C infection

Where it's running

• Vancouver Prostate Centre
  Vancouver, British Columbia, Canada Recruiting
• Men's Health Clinic
  Winnipeg, Manitoba, Canada Recruiting
• Centre of Applied Urology Research, Nova Scotia Health Authority
  Halifax, Nova Scotia, Canada Recruiting
• London Health Sciences Centre - Victoria Hospital
  London, Ontario, Canada Recruiting
• UHN - Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting
• McGill University Health Center
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Marie-Pier St-Laurent, Dr. — Vancouver Prostate Centre
• Study coordinator: Dasa Durkotova
• Email: ddurkotova@prostatecentre.com
• Phone: 236 869 3437

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.