drugset / Trial / NCT04375813
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sirolimus | Small molecule | 0.5 mg | Oral |