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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the good and bad effects of omeprazole with either cabazitaxel or docetaxel. Researchers think omeprazole may help the other drugs work better. It is for adults whose prostate cancer keeps growing despite treatment to lower testosterone and who have already received docetaxel for this condition.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have prostate cancer that keeps growing despite treatment to lower testosterone, and have received docetaxel for this condition.
  • Have cancer that is getting worse based on PSA blood tests or changes in cancer in bones, lymph nodes, or other areas.
  • Be able to do self-care and be out of bed or a chair for at least half of waking hours (ECOG score 0–2).
  • Be expected to live longer than 2 months.
  • Agree to use barrier birth control, such as condoms, or avoid sex before joining and for 3 months after stopping study treatment.
  • Be able and willing to give written consent, either yourself or through a legally authorized representative.
  • Meet study blood test limits for infection-fighting cells, platelets that help blood clot, and liver and kidney function.

Who can't join

  • Are receiving another experimental drug.
  • Have had an allergic reaction to drugs similar to omeprazole or taxane cancer drugs.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat; or have mental health or social problems that would make it hard to follow study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

NC