Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two treatments—omeprazole combined with either cabazitaxel or docetaxel—on men with a type of prostate cancer that has not responded to hormone therapy. Researchers want to see if omeprazole can help these chemotherapy drugs work better. The trial is currently looking for men aged 18 and older who have previously been treated with taxane chemotherapy and whose cancer has continued to progress.

To be part of this study, participants must have a life expectancy of at least two months and meet certain health criteria. They should not be taking other experimental drugs or have serious health issues that could interfere with the trial. If eligible and they choose to participate, men will be closely monitored for any positive or negative effects of the treatments. It’s important for participants to understand the study and agree to follow the guidelines, including using contraception during the trial. This study aims to find better ways to treat prostate cancer that doesn’t respond to usual therapies.

Gender

MALE

Eligibility 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.