NCT04337580RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Apr 2020
- Start date
- 5 Mar 2021
- Primary completion date
- Feb 2028
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Prostate cancer
- NCT number
- NCT04337580
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 5 Mar 2021 to the primary completion date, Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may not be receiving any other investigational agents.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Who the study is looking for
- Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting
- Cancer Progression as defined by prostate cancer working group 3 (PCWG3) any type- prostate specific antigen only, bone only +nodal, nodal only or new lesions
- Age 18 or older.
- ECOG 0, 1, or 2
- Life expectancy of greater than 2 months
- Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for three (3) months after study treatment discontinuation.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- Organ \& marrow function as defined below: Absolute neutrophil count \>1,200/mcL, Platelets \>75,000/mcL; total bilirubin = within normal institutional limits; AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal; creatinine \<2.5 X institutional upper limit of normal
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| W.G. (Bill) Hefner VA Medical Center Coordinator of this site? Confirm its status | Salisbury | United States | Recruiting |
| Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.