NCT04337580

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Refractory Cancer
• Castration Resistant Prostatic Cancer

Interventions

Type	Name	Description
DRUG	Omeprazole 80 mg twice daily	Participants will be treated with omeprazole 80 mg twice daily on Day 0. Within 10 days of starting omeprazole, participants will be treated with standard prostate cancer dosing of every three week docetaxel or cabazitaxel based on package insert. Participants that have only had docetaxel will be retreated with docetaxel along with concurrent omeprazole. Patients that have had both docetaxel and cabazitaxel will be retreated with either cabazitaxel or docetaxel (investigators choice) along with concurrent omeprazole. However investigators encourage investigator to choose cabazitaxel in patients previously treated with cabazitaxel.

Timeline

• Start date: 2021-03-05
• Primary completion: 2028-02-01
• Completion: 2028-03-01
• First posted: 2020-04-07
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study