Clinical trial · Interventional
Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer
NCT04337580CI-TRIAL-00107813FASNrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Resistant Prostatic Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omeprazole 80 mg twice daily | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omeprazole Plus Standard of Care for Prostate Cancer Regimen
- description
- This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
- interventionNames
- Drug: Omeprazole 80 mg twice daily
Primary outcomes (2)
- measure
- Change Radiographic Response - RECIST 1.1
- timeFrame
- Up to approximately 2 years
- description
- Response will be defined by RECIST 1.1 as defined by Prostate Cancer Clinical Trials Working Group 3 definition for complete response (CR) - disappearance of all target lesions); partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions); progressive disease (PD) (at least a 20% increase in the sum of diameters or target lesions); stable disease (SD) (neither sufficient shrinkage to qualify for partial response nor sufficient to qualify for progressive disease); or not evaluable (NE).
- measure
- Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 prostate cancer working group 3 (PCWG3) any type- prostate specific antigen 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.
References
Publications (0)
Data not yet available
No reference posted for this study.