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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: Recruiting Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by VA Office of Research and Development.
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 226-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to determine any adverse events and assess the grade. All toxicity as well as Grade 3 or higher adverse events will be analyzed.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
What NCT05519241 shows while recruiting
NCT05519241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 226-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Non-muscle Invasive Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05519241's enrollment target sits among peer trials
29 26th of 30 higher than 5 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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