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Anti-cancer agent

Niclosamide for 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

Study Summary

This trial is testing a combination of drugs to see if they're more effective than either one alone in treating prostate cancer that's resistant to hormone therapy.

Eligible Conditions
  • Prostate Cancer

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Overall survival
PFS
Rate of PSA response which is defined as >= 50% decrease
+1 more
Other outcome measures
Analysis of laboratory correlatives

Side effects data

From 2021 Phase 2 trial • 73 Patients • NCT04399356
21%
Nausea
9%
Skin rash
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Niclosamide- Experimental Group

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
~2760
Niclosamide
2017
Completed Phase 3
~2280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,213 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
PandomedxOTHER
Mamta ParikhLead Sponsor
6 Previous Clinical Trials
204 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer
Mamta Parikh 2017. "Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03123978.
~1 spots leftby Apr 2025
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