A Phase 1b Study of Enzalutamide plus CC-115 in Men with Castration-Resistant Prostate Cancer (CRPC) (Sponsor Protocol c15-160)
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary purpose of this study is to determine if the combination of fixed dose of enzalutamide with the study drug CC-115 will overcome the resistance to prior hormonal therapy and promote prostate tumor death through inhibition of both AR and /P13K signaling and accumulation of unrepaired DNA damage.
Must have proof of prostate cancer. Willing to provide a tumor sample or archived biopsy. Must have progression of disease upon entry. Good performance status. Normal organ function shown in initial laboratory values. Able to take oral pills. Must adhere to the study visit schedule. Cannot have had prior abiraterone, enzalutamide or ketoconazole. Can not have clinically significant cardiac disease. Cannot have uncontrolled diabetes.
Patients will take Enzalutamide 160 mgs by mouth every day and study drug CC-115 based upon the escalation dose of 5/10/or 20 mgs by mouth twice a day. The patient will be in clinic for blood draws throughout the day on C1D1. Will also be in clinic on days 8, 15, and 22 of the first cycle Each cycle is 28 days in length.
12/12/2019 05:03 AM