Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT02807805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
Sponsor:
Mamta Parikh
Organization:
Study Overview
Official Title:
A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.
SECONDARY OBJECTIVES:
I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).
II. To evaluate the progression-free survival (PFS) and overall survival of CRPC patients treated with PDMX1001/niclosamide (niclosamide), abiraterone (abiraterone acetate) and prednisone.
III. To assess the toxicity of PDMX1001/niclosamide, abiraterone and prednisone given in combination.
OUTLINE:
Patients receive abiraterone acetate orally (PO) once a day (QD), niclosamide PO twice a day (BID) and prednisone PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 months.
I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.
SECONDARY OBJECTIVES:
I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).
II. To evaluate the progression-free survival (PFS) and overall survival of CRPC patients treated with PDMX1001/niclosamide (niclosamide), abiraterone (abiraterone acetate) and prednisone.
III. To assess the toxicity of PDMX1001/niclosamide, abiraterone and prednisone given in combination.
OUTLINE:
Patients receive abiraterone acetate orally (PO) once a day (QD), niclosamide PO twice a day (BID) and prednisone PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCDCC#260 | OTHER | UC Davis IRB | View | |
| UCDCC#260 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2016-00779 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |