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NCT06173349 · ClinicalTrials.gov registry record · Phase 1
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
A Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06173349: Recruiting Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by University of California, Davis.
NCT06173349 is a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8 that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 12 participants, below the 244-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06173349, a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.
Primary Outcome
Number of participants experiencing treatment-related AEs, classified by severity and graded according to the NCI CTCAE v5.0
Conditions Studied
Interventions
- DRUG PLZ4-coated paclitaxel loaded micelles (PPM)
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-11-22 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06173349 shows while recruiting
NCT06173349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 244-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Stage 0a Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which PLZ4-coated paclitaxel loaded micelles (PPM) is the first listed.
NCT06173349 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06173349 about?
NCT06173349 is a clinical study titled "PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer". This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a b...
What is the current status of trial NCT06173349?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-11-22. Estimated completion is 2027-06.
What conditions does trial NCT06173349 study?
This clinical trial studies the following conditions: Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Recurrent Non-Muscle Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT06173349?
The interventions under investigation include: PLZ4-coated paclitaxel loaded micelles (PPM) (DRUG).
Who is sponsoring clinical trial NCT06173349?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06173349 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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