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Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

NCT04375813 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

eRapa

0.5mg eRapa (encapsulated rapamycin) oral capsules

DRUG

Placebos

placebo capsules visually identical to eRapa oral capsules

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Robert Svatek

    lead OTHER

Principal Investigators

  • Robert S Svatek, MD, MSC · UT Health San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375813 on ClinicalTrials.gov