Metastatic Prostate Carcinoma Clinical Trial
Official title:
A Phase I Study of Niclosamide in Combination With Enzalutamide in Men With Castration-Resistant Prostate Cancer
This phase I trial studies the side effects and best dose of niclosamide when given together with enzalutamide in treating patients with castration resistant prostate cancer that has spread from the primary site to other places in the body. Androgens such as testosterone can cause the growth of prostate cancer cells. Drugs like enzalutamide block androgens from driving tumor growth; however, when androgen receptor splice variants are present, these drugs may not be effective. Niclosamide may decrease the amount of androgen receptor splice variant present within tumor cells, thus promoting the anti-tumor effects of enzalutamide. Giving niclosamide together with enzalutamide may be a better treatment for prostate cancer.
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of three-times-daily (TID) oral niclosamide combined
with enzalutamide in men with castration-resistant prostate cancer (CRPC) that has progressed
on abiraterone (abiraterone acetate).
SECONDARY OBJECTIVES:
I. Determine the effect of niclosamide plus enzalutamide on androgen receptor splice variant
(AR-V) expression as determined by quantitative
reverse-transcriptase-polymerase-chain-reaction (qRT-PCR).
II. Determine the pharmacokinetic profile of three-times-daily (TID) oral niclosamide in men
with castration-resistant prostate cancer (CRPC) that has progressed on abiraterone.
III. Determine the prostate specific antigen (PSA) response rate (i.e. proportion of subjects
with >= 50% decline in PSA from pre-study baseline) after 28-days of niclosamide plus
enzalutamide.
IV. Determine the effect of niclosamide plus enzalutamide on protein expression and the
transcriptional program of circulating tumor cells.
OUTLINE: This is a dose-escalation study of niclosamide.
Patients receive niclosamide orally (PO) TID and enzalutamide PO daily. Treatment continues
for 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at days 58 and 88.
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