Status:
RECRUITING
Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Refractory Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 om...
Detailed Description
Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using Pros...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04337580
Start Date
March 5 2021
End Date
April 1 2028
Last Update
October 27 2025
Active Locations (2)
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1
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States, 28144
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157