Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02807805
Other study ID # 871875
Secondary ID UCDCC#260UCDCC#2
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date July 2024

Study information

Verified date November 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.


Description:

PRIMARY OBJECTIVES: I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline. SECONDARY OBJECTIVES: 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. OUTLINE: 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 37
Est. completion date July 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients must have histologically or cytologically confirmed cancer of prostate (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP - Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable): - Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug - Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans) - Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (second [2nd] beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure - Measurable disease is not required - Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug - Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug - Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease - If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher - Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) - Life expectancy of greater than 6 months - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Total bilirubin within normal institutional limits - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 × institutional upper limit of normal - Creatinine =< 1.5 x institutional upper limit of normal - Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abiraterone and PDMX1001/niclosamide administration - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients who are receiving any other investigational agents within the preceding 4 weeks - Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES - Patient has received abiraterone or ketoconazole for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, enzalutamide, flutamide and nilutamide) or chemotherapy (docetaxel, cabazitaxel or mitoxantrone) is allowed - Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers - Patients with known brain metastases should be excluded - History of allergic reactions attributed to compounds of similar chemical or biologic composition to abiraterone or PDMX1001/niclosamide - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible - Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) - Patients with an active bleeding diathesis - History of noncompliance to medical regimens - Patients unwilling to or unable to comply with the protocol - Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been taken care of

Study Design


Intervention

Drug:
Abiraterone Acetate
Given PO
Niclosamide
Given PO
Prednisone
Given PO

Locations

Country Name City State
United States University of California Davis Comprehensive Cancer Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Mamta Parikh National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PSA response rate Percent of patients achieving greater than or equal to 50% PSA declines following initiation of treatment Up to 2 years
Secondary 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 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. 4 weeks
Secondary Overall response as determined by PCWG2 criteria 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
Secondary Overall survival Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed. Up to 2 years
Secondary PFS 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. Up to 2 years
See also
  Status Clinical Trial Phase
Terminated NCT02491411 - Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel N/A
Active, not recruiting NCT01685125 - Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT00936975 - Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases Phase 2
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Active, not recruiting NCT03511196 - Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Early Phase 1
Completed NCT01881867 - CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Completed NCT01385059 - Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer Phase 2
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT01026623 - Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer Phase 1/Phase 2
Completed NCT01682941 - Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen N/A
Terminated NCT00536991 - Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer Phase 1/Phase 2
Completed NCT00074022 - GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors Phase 1/Phase 2
Completed NCT03707184 - Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone Phase 2
Withdrawn NCT00003534 - Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer Phase 2
Recruiting NCT04113096 - Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer Early Phase 1
Active, not recruiting NCT03344211 - Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer Phase 2
Terminated NCT02985021 - Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies Phase 2
Recruiting NCT02615223 - Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer N/A
Terminated NCT00527124 - Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy Phase 2