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NCT05519241 · ClinicalTrials.gov registry record · Phase 1

A Phase I Intravesical PPM Therapy for NMIBC

A Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 1
Development phase
29
Enrollment target
1
Study location

NCT05519241 is a Phase 1 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 29 participants, below the 232-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05519241, a Phase 1 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 1
Development phase
29 participants
Enrollment target
1
Study location

Study Summary

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug BCG. Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.

Conditions Studied

Non-muscle Invasive Bladder Cancer

Interventions

  • DRUG PLZ4-coated paclitaxel-loaded micelles (PPM)

Study Locations (1)

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2022-10-10
Est. Completion 2026-08-31
Phase Phase 1

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT05519241

The ClinicalTrials.gov registry entry for NCT05519241 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 232-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (87% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 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 1 intervention - of which PLZ4-coated paclitaxel-loaded micelles (PPM) is the first listed.

NCT05519241 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05519241 about?

NCT05519241 is a clinical study titled "A Phase I Intravesical PPM Therapy for NMIBC". This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specificall...

What is the current status of trial NCT05519241?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2022-10-10. Estimated completion is 2026-08-31.

What conditions does trial NCT05519241 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.

What interventions are being tested in trial NCT05519241?

The interventions under investigation include: PLZ4-coated paclitaxel-loaded micelles (PPM) (DRUG).

Who is sponsoring clinical trial NCT05519241?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05519241 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.