RecruitingPhase 2NCT04337580

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


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Mar 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether inhibiting an enzyme called fatty acid synthase (FASN) — which cancer cells use to fuel their growth — can slow down castration-resistant prostate cancer that has already progressed after standard chemotherapy. The drug being studied works by blocking this energy pathway in tumor cells. **You may be eligible if...** - You are 18 years or older - You have prostate cancer that no longer responds to hormone therapy (castration-resistant) - You have already received docetaxel chemotherapy for your castration-resistant disease - Your cancer is progressing (rising PSA, new bone lesions, or lymph node growth) - You are in reasonably good physical condition (ECOG 0–2) - You agree to use contraception during and for 3 months after treatment **You may NOT be eligible if...** - You are currently taking another experimental drug - You have an allergy to omeprazole or taxane drugs - You have an uncontrolled infection, heart failure, unstable heart condition, or psychiatric illness that would prevent compliance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmeprazole 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.


Locations(2)

W.G. Bill Hefner VA Medical Center

Salisbury, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT04337580


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