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Clinical Trial 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.


Clinical Trial Description

Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by partial response (PR) or complete response (CR) Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus): - Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target - Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current "failing" taxane regimen. (16) - Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04337580
Study type Interventional
Source Wake Forest University Health Sciences
Contact Study Nurse
Phone 336-716-5440
Email jethomas@wakehealth.edu
Status Recruiting
Phase Phase 2
Start date March 5, 2021
Completion date September 2024

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