Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Patients must have castrate refractory prostate cancer with prior taxane treatment (docetaxel or cabazitaxel) which was used in the castrate refractory setting

• Cancer Progression as defined by PCWG3

• 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 the duration of study participation.

• 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 Criteria:

• 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.