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Anti-metabolites

ST-02 for Transitional Cell Carcinoma

Phase 2 & 3

Recruiting

Led By Peter Black, Dr.

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

"This trial aims to test a new treatment called ST-02 for patients with low-grade Upper Tract Urothelial Carcinoma (UTUC). The study will determine if ST-02 can

Who is the study for?

This trial is for adults with low-grade, noninvasive Upper Tract Urothelial Carcinoma (UTUC) in the kidney's drainage system. Candidates must have a life expectancy over 12 months and at least one measurable tumor. Women of childbearing potential and men with partners of childbearing potential must use contraception.Check my eligibility

What is being tested?

The study tests ST-02, a mucoadhesive gemcitabine suspension designed for direct application to UTUC. Participants will receive this treatment weekly for six weeks to see if it can eliminate UTUC within three months and assess its safety over a year.See study design

What are the potential side effects?

While specific side effects are not listed here, gemcitabine can typically cause flu-like symptoms, nausea, low blood counts leading to increased infection risk or bleeding, liver and kidney issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit

Secondary outcome measures

Clinical impact of PR in not endoscopically resectable UTUC

Durable efficacy

Event-Free Survival (EFS)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ST-02Experimental Treatment1 Intervention

ST-02 is a new gemcitabine formulation for instillation into the upper urinary tract. Eligible participants will be enrolled and receive ST-02 once weekly for six weeks in a retrograde or antegrade fashion at the discretion of the treating urologist.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,048 Total Patients Enrolled

Peter Black, Dr.Principal InvestigatorVancouver Prostate Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this clinical investigation?

"Affirmative. The information provided on clinicaltrials.gov indicates that this research endeavor is presently seeking candidates for involvement. Initial posting of the study occurred on March 1, 2024, with the latest update dated March 28, 2024. Recruitment aims to enroll a total of 70 participants at a single designated site."

Answered by AI

Are there currently any vacancies for participants in this ongoing trial?

"Affirmative. Information accessible on clinicaltrials.gov confirms the ongoing recruitment of subjects for this trial, initially published on March 1st, 2024 and last revised on March 28th, 2024. This study aims to enroll a total of 70 participants from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

Peter Black 2024. "Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06124976.