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Fatty Acid Synthase Inhibitor
Omeprazole for Prostate Cancer (FASN Trial)
Phase 2
Recruiting
Led By Michael Goodman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
ECOG 0, 1, or 2
Must not have
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
History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if adding omeprazole, a common stomach acid reducer, can help prostate cancer patients who are not responding well to their current treatments with cabazitaxel or docetaxel. Omeprazole may block an enzyme that helps cancer cells grow, potentially making the cancer drugs more effective. Omeprazole has been widely studied for its interactions with other drugs.
Who is the study for?
Men over 18 with advanced prostate cancer that's gotten worse despite hormone therapy and previous taxane treatment (like docetaxel). They must be fairly active, have good organ function, expect to live more than 2 months, and agree to use birth control. Can't join if they're on other experimental drugs or have serious health issues like heart failure or uncontrolled infections.
What is being tested?
The trial is testing the effects of omeprazole combined with cabazitaxel or docetaxel chemotherapy on men with castration-resistant prostate cancer. The goal is to see if omeprazole can enhance the effectiveness of chemotherapy.
What are the potential side effects?
Omeprazole may cause stomach pain, constipation, gas, nausea/vomiting; rare but severe side effects include rash, dizziness, kidney problems. Chemotherapy can lead to hair loss, fatigue, increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and perform daily activities.
Select...
My cancer has worsened according to specific criteria.
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My prostate cancer is resistant to hormone therapy and I've had taxane treatment.
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My blood counts and liver/kidney functions are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
I am allergic to medications similar to omeprazole or taxanes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change Radiographic Response - RECIST 1.1
Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Secondary study objectives
Fatty Acid Synthase Activity - Post Omeprazole Use
Fatty Acid Synthase Activity - Pre Omeprazole Use
Patient Reported Outcome - Pain
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Omeprazole Plus Standard of Care for Prostate Cancer RegimenExperimental Treatment1 Intervention
This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,560 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,940 Patients Enrolled for Prostate Cancer
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,315 Total Patients Enrolled
19 Trials studying Prostate Cancer
1,676 Patients Enrolled for Prostate Cancer
Michael Goodman, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
27 Total Patients Enrolled