RecruitingPhase 2NCT04375813

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Phase II Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention


Sponsor

Robert Svatek

Enrollment

166 participants

Start Date

Jan 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that eRapa decreases the risk of cancer relapse for patients with NMIBC. Secondary hypotheses are that eRapa can improve certain immune parameters and improve cognition and physical function without adversely affecting patient-reported outcomes and quality of life.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether encapsulated rapamycin (eRapa) — a drug that may slow cancer cell growth — can prevent non-muscle-invasive bladder cancer from coming back after surgery. It is designed for people whose early-stage bladder cancer was completely removed but who are at risk for recurrence. **You may be eligible if...** - You are 18 or older - You have early-stage bladder cancer (Ta, Tis, or T1 — meaning it has not grown into the muscle wall) confirmed by biopsy in the past 90 days - All visible tumors have been removed - You have not previously received BCG (a bladder cancer immunotherapy treatment) or rapamycin - You are not on oral corticosteroids - You do not have active infections **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle wall (T2 or higher) - You have another active cancer requiring treatment - You have lymph node involvement or metastatic disease - You are pregnant, breastfeeding, or unwilling to use contraception during the study - You have a history of prior BCG or rapamycin treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGeRapa

0.5mg eRapa (encapsulated rapamycin) oral capsules

DRUGPlacebos

placebo capsules visually identical to eRapa oral capsules


Locations(2)

UT Southwestern Medical Center

Dallas, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04375813


Related Trials