Clinical trial · Interventional
Niclosamide and Enzalutamide in Treating Patients With Castration-Resistant, Metastatic Prostate Cancer
A Phase I Study of Niclosamide in Combination With Enzalutamide in Men With Castration-Resistant Prostate Cancer
NCT02532114CI-TRIAL-00032558completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Levels of Testosterone | — | UNRESOLVED | — |
| Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Niclosamide | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (niclosamide, enzalutamide)
- description
- Patients receive niclosamide PO TID and enzalutamide PO daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Enzalutamide
- Other: Laboratory Biomarker Analysis
- Drug: Niclosamide
- Other: Pharmacological Study
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- timeFrame
- Up to 28 days
- measure
- Recommended phase 2 dose
- timeFrame
- Up to 28 days
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
* Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Documented histologically confirmed adenocarcinoma of the prostate
* Patient must have evidence of castration resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 \[PCWG2\] criteria) and a castrate serum testosterone level (i.e. =\< 50 mg/dL)
* Patient must be eligible for treatment with enzalutamide
* Patient must have previously progressed on abiraterone (either by PCWG2 criteria or Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria)
* Documented metastatic disease on bone scan, computed tomography (CT) scan or magnetic resonance imaging (MRI)
Exclusion Criteria:
* Have known allergies, hypersensitivity, or intolerance to enzalutamide or niclosamide or their excipients
* Ongoing systemic therapy (other than a gonadotropin releasing hormone \[GnRH\] agonist/antagonist) for prostate cancer including, but not limited to:
* Cytochrome P450, family 17 (CYP-17) inhibitors (e.g. ketoconazole, abiraterone)
* Antiandrogens (e.g. bicalutamide, nilutamide)
* Second generation antiandrogens (e.g. ARN-509)
* Note: patients receiving ongoing treatment with enzalutamide will be allowed to join the study
* Immunotherapy (e.g. sipuleucel-T, ipilimumab)
* Chemotherapy (e.g. docetaxel, cabazitaxel)
* Radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153)
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
* Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
* Severe hepatic impairment (Child-Pugh class C)
* Severe renal impairment (creatinine clearance =\< 30 ml/min)
* History of prior seizures
* Central nervous system metastases
* Symptomatic patients who, in the opinion of the investigator, may benefit from docetaxel-based chemotherapyReferences
Publications (1)
- DERIVEDSchweizer MT, Haugk K, McKiernan JS, Gulati R, Cheng HH, Maes JL, Dumpit RF, Nelson PS, Montgomery B, McCune JS, Plymate SR, Yu EY. A phase I study of niclosamide in combination with enzalutamide in men with castration-resistant prostate cancer. PLoS One. 2018 Jun 1;13(6):e0198389. doi: 10.1371/journal.pone.0198389. eCollection 2018. PMID 29856824