NCT03123978

Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer

A Safety Trial of Enzalutamide in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mamta Parikh · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose and side effects of niclosamide when given together with enzalutamide in treating patients with castration-resistant prostate cancer that has come back or has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells. Niclosamide may block signals that enhance prostate cancer cell growth. Giving enzalutamide and niclosamide may work better in treating patients with castration-resistant prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of niclosamide (PDMX1001/niclosamide) and enzalutamide in patients with castration-resistant prostate cancer (CRPC). II. To determine the recommended phase II dose (RP2D) of PDMX1001/niclosamide and enzalutamide for the treatment of patients with CRPC. SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of PDMX1001/niclosamide. II. To determine the number of patients who have a prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline. III. To identify overall responses as determined by the Prostate Cancer Working Group 2 (PCWG2) criteria. IV. To evaluate the progression-free survival (PFS) of CRPC patients treated with PDMX1001/niclosamide and enzalutamide. V. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens. OUTLINE: This is a dose-escalation study of niclosamide. Patients receive niclosamide orally (PO) twice daily (BID) and enzalutamide PO once daily (QD) on weeks 1-4. 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	Enzalutamide	Given PO
DRUG	Niclosamide	Given PO

Timeline

• Start date: 2017-01-09
• Primary completion: 2022-01-14
• Completion: 2022-04-19
• First posted: 2017-04-21
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study