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
Wake Forest University Health Sciences
50 participants
Mar 5, 2021
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
Inclusion Criteria8
- Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting
- Cancer Progression as defined by PCWG3 any type- PSA 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
Exclusion Criteria3
- Patients may not be receiving any other investigational agents.
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT04337580