Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Trial Status: Closed to Accrual
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Inclusion Criteria
- Men with metastatic castration-resistant prostate cancer
- Progressive disease on androgen deprivation therapy
- Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
- ECOG performance score ≤ 1
- Estimated life expectancy of ≥ 12 months
Exclusion Criteria
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
- Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
- History of brain metastasis, active leptomeningeal disease or seizure
- Severe cardiovascular or hepatic disease
- Pituitary or adrenal dysfunction
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Mary-Ellen Taplin
Phone: 866-790-4500
Email:
mtaplin@partners.org
Trial Phase Phase IV
Trial Type Treatment
Lead Organization
Pfizer Inc
- Primary ID MDV3100-10
- Secondary IDs NCI-2014-01568, 2013-000722-54, C3431013, PLATO, C3431013
- Clinicaltrials.gov ID NCT01995513