NCT04375813

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Robert Svatek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a multi-site phase II double-blind randomized trial. Subjects will be randomized into placebo arm or intervention arm with low dose (0.5 mg) eRapa (encapsulated rapamycin) Monday-Friday for one year or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for 2 years, then every 6 months for 2 years, and at year 5. Some patients may also concurrently receive BCG immune therapy maintenance (weekly for 6 weeks for induction period, weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 7 maintenance cycles following tumor removal) per standard of care. Patient-reported outcome (PRO) assessments, cognitive assessments, and physical assessments will be completed according to the study calendar. Research blood to assess safety, immune response and rapamycin level will be collected regularly throughout the study period. Participants will be followed for up to 5 years following enrollment.

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	eRapa	0.5mg eRapa (encapsulated rapamycin) oral capsules
DRUG	Placebos	placebo capsules visually identical to eRapa oral capsules

Timeline

• Start date: 2021-01-25
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-05-05
• Last updated: 2025-05-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study