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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04716725 -
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
| Withdrawn |
NCT05034562 -
Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
| Recruiting |
NCT02935023 -
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
|
Phase 2 | |
| 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 | |
| Terminated |
NCT04134208 -
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
|
Phase 4 | |
| Completed |
NCT01881867 -
CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT04423211 -
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
|
Phase 3 | |
| Active, not recruiting |
NCT02807805 -
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
|
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 | |
| Suspended |
NCT04071236 -
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02522715 -
Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04585932 -
Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
|
Phase 2 | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Active, not recruiting |
NCT05241860 -
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
|
Phase 2 | |
| Terminated |
NCT02985021 -
Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies
|
Phase 2 | |
| Not yet recruiting |
NCT05487846 -
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
|
N/A | |
| Recruiting |
NCT04159896 -
ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT04314401 -
National Cancer Institute "Cancer Moonshot Biobank"
|
||
| Completed |
NCT05547386 -
68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer
|
Phase 3 |