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Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
RECRUITINGPhase 2Sponsored by Wake Forest University Health Sciences
Actively Recruiting
PhasePhase 2
SponsorWake Forest University Health Sciences
Started2021-03-05
Est. completion2028-02
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT04337580
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria: * 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 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.
Conditions4
CancerCastration-Resistant Prostatic CancerProstate CancerRefractory Cancer
Locations2 sites
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, 28144
Study Coordinatorahumbert@wakehealth.edu
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Study Coordinatorahumbert@wakehealth.edu
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Actively Recruiting
PhasePhase 2
SponsorWake Forest University Health Sciences
Started2021-03-05
Est. completion2028-02
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT04337580