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NCT04375813 · ClinicalTrials.gov registry record · Phase 2
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
A Phase 2 study of Non-muscle Invasive Bladder Cancer, sponsored by Robert Svatek.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
- 2
- Study locations
NCT04375813: Recruiting Phase 2 study of Non-muscle Invasive Bladder Cancer, sponsored by Robert Svatek.
NCT04375813 is a Phase 2 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by Robert Svatek. The registered enrollment target is 166 participants, below the 221-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (25% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375813, a Phase 2 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by Robert Svatek.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The primary analysis will be the estimation of the RFS rate with the 95% confidence interval and comparison of the rate to the historical rate of 68% using the single arm log-rank test (one-sided alpha = 0.05). If the observed rate of RFS is 80% the expected number of events is about 20-28. Recurrence confirmed by pathologic examination of biopsied tissue.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG eRapa
Study Locations (2)
Texas
- UT Southwestern Medical Center - Dallas
- UT Health San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What NCT04375813 shows while recruiting
NCT04375813 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT04375813 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04375813 about?
NCT04375813 is a clinical study titled "Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention". 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 ...
What is the current status of trial NCT04375813?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2021-01-25. Estimated completion is 2026-01.
What conditions does trial NCT04375813 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT04375813?
The interventions under investigation include: Placebos (DRUG), eRapa (DRUG).
Who is sponsoring clinical trial NCT04375813?
This trial is sponsored by Robert Svatek, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375813 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04375813's enrollment target sits among peer trials
166 12th of 30 higher than 19 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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