NCT02807805

Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Mamta Parikh · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Carcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given PO
DRUG	Niclosamide	Given PO
DRUG	Prednisone	Given PO

Timeline

• Start date: 2016-10-01
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2016-06-21
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States