Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
Start Date
3/5/2021
Completion Date
3/1/2028
Summary
The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.
Detailed Description
Primary Objective(s): Obtain RECIST Overall Response Rate (ORR) of 29% by adding the fatty acid synthase inhibitor, omeprazole to cabazitaxel. ORR defined by partial response (PR) or complete response (CR) in tumor size and bone metastasis Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus): * Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to cabazitaxel regimen * Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Omeprazole 80 mg twice daily
Conditions
Locations
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina 28144
United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
United States