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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 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 227-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 1 state.

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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.

Interventions

  • DRUG Placebos
  • DRUG eRapa

Study Locations (2)

Texas

  • UT Southwestern Medical Center - Dallas
  • UT Health San Antonio - San Antonio

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2021-01-25
Est. Completion 2026-01
Phase Phase 2

Sponsor

Robert Svatek

1 total trials

What the Registry Record Tells You About NCT04375813

The ClinicalTrials.gov registry entry for NCT04375813 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (27% lower). The listed sponsor is Robert Svatek, which has 1 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.