Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02807805|
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer||Drug: Abiraterone Acetate Drug: Niclosamide Drug: Prednisone||Phase 2|
I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.
I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).
II. To evaluate the progression-free survival (PFS) and overall survival of CRPC patients treated with PDMX1001/niclosamide (niclosamide), abiraterone (abiraterone acetate) and prednisone.
III. To assess the toxicity of PDMX1001/niclosamide, abiraterone and prednisone given in combination.
IV. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.
Patients receive abiraterone acetate orally (PO) once a day (QD), niclosamide PO twice a day (BID) and prednisone PO BID. 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 :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Treatment (abiraterone acetate, niclosamide, prednisone)
Patients receive abiraterone acetate PO QD, niclosamide PO BID and prednisone PO BID. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
- PSA response rate [ Time Frame: Up to 2 years ]Percent of patients achieving greater than or equal to 50% PSA declines following initiation of treatment
- Incidence of dose limiting toxicity defined as any grade III non-hematologic toxicity not reversible to grade II or less within 96 hours, or any grade IV toxicity [ Time Frame: 4 weeks ]Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.0. 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.
- Overall response as determined by PCWG2 criteria [ Time Frame: From the time measurement criteria are met for complete response/partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years ]
- Overall survival [ 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.
- PFS [ 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. Will be compared with the historic control of abiraterone alone.
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): NCT02807805
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Mamta Parikh 916-734-3772 email@example.com|
|Principal Investigator: Mamta Parikh|
|Principal Investigator:||Mamta Parikh||University of California, Davis|