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Anti-cancer agent

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

Phase 1

Waitlist Available

Research Sponsored by Mamta Parikh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety and best dose of niclosamide and enzalutamide in patients with castration-resistant prostate cancer. Niclosamide blocks growth signals, and enzalutamide reduces/block androgen. Enzalutamide is a second-generation androgen receptor antagonist approved for treating castration-resistant prostate cancer, showing significant efficacy in clinical trials. The goal is to find an effective treatment for this hard-to-treat cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events of grade 3 or higher assessed by National Cancer Institute Common Terminology Criteria for Adverse Events 4.0

RP2D of niclosamide and enzalutamide

Secondary study objectives

Overall survival

PFS

Rate of PSA response which is defined as >= 50% decrease

+1 more

Other study objectives

Analysis of laboratory correlatives

Side effects data

From 2021 Phase 2 trial • 73 Patients • NCT04399356

21%

Nausea

Skin rash

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

Niclosamide- Experimental Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (niclosamide, enzalutamide)Experimental Treatment2 Interventions

Patients receive niclosamide PO BID and enzalutamide PO QD on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Niclosamide

2017

Completed Phase 3

~2280