drugset / Trial / NCT04375813

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

NCT04375813

Phase 2 Active not recruiting 166 enrolled Robert Svatek National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2021-01-25
Primary completion
2027-01
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sirolimus Small molecule 0.5 mg Oral