drugset / Trial / NCT02532114
Niclosamide and Enzalutamide in Treating Patients With Castration-Resistant, Metastatic Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-12-31
- Primary completion
- 2017-11-30
- Completion
- 2017-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niclosamide | Unknown | 500 mg | Oral |
| Subject | Niclosamide | Unknown | 1000 mg | Oral |
| Subject | Niclosamide | Unknown | 1500 mg | Oral |
| Background | Enzalutamide | Other / unclassified | — | Oral |