Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03123978|
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer||Drug: Enzalutamide Drug: Niclosamide||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety Trial of Enzalutamide in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||January 9, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Treatment (niclosamide, enzalutamide)
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.
- Incidence of adverse events of grade 3 or higher assessed by National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Up to 4 weeks ]Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.
- RP2D of niclosamide and enzalutamide [ Time Frame: Up to 2 years ]Determination of dose limiting toxicity as graded according to NCI CTCAE 4.0.
- Overall survival [ Time Frame: Up to 5 years ]Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
- PFS [ Time Frame: Up to 5 years ]Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
- Rate of PSA response which is defined as >= 50% decrease [ Time Frame: Baseline up to 2 years ]The characteristics of the study participants will be summarized using frequencies and percentages for categorical variables and descriptive statistics (mean, standard deviation, median, minimum, maximum) for numeric variables. The proportion of participants who experience a PSA response will be computed, along with the exact 95% confidence interval.
- Time to treatment failure [ Time Frame: Up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
- Analysis of laboratory correlatives [ Time Frame: Up to 2 years ]Will be performed between patients who respond and those who do not respond, and between specimens obtained during response and those specimens obtained during resistance in the same patients. Will be descriptive and exploratory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123978
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Mamta Parikh 916-734-3772 firstname.lastname@example.org|
|Principal Investigator: Mamta Parikh|
|Principal Investigator:||Mamta Parikh||University of California, Davis|