Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173349
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Brief Title:
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Sponsor:
Mamta Parikh
Organization:
University of California Davis
Study Overview
Official Title:
A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles PPM in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the safety and tolerability of PPM administered through intravesical instillation
SECONDARY OBJECTIVES
I Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy
II Assess event-free survival rate at 12 months
OUTLINE
Patients receive PPM intravesically over 1 hour once a week QW for 6 weeks in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI or positron emission tomography PET and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 3 weeks 6 weeks and then every 3 months per standard of care for 2 years
I Evaluate the safety and tolerability of PPM administered through intravesical instillation
SECONDARY OBJECTIVES
I Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy
II Assess event-free survival rate at 12 months
OUTLINE
Patients receive PPM intravesically over 1 hour once a week QW for 6 weeks in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI or positron emission tomography PET and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 3 weeks 6 weeks and then every 3 months per standard of care for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10047 | REGISTRY | None | None |
| UCDCC309 | OTHER | None | None |
| P30CA093373 | NIH | University of California Davis Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA093373 |