Clinical Trials /

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

NCT04337580

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
  • Official Title: FASN Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer Salvaging Taxane Failure

Clinical Trial IDs

  • ORG STUDY ID: WFBCCC 85220
  • SECONDARY ID: P30CA012197
  • NCT ID: NCT04337580

Conditions

  • Prostate Cancer
  • Refractory Cancer
  • Castration Resistant Prostatic Cancer

Interventions

DrugSynonymsArms
Omeprazole 80 mg twice dailyOmeprazole Plus Standard of Care for Prostate Cancer Regimen

Purpose

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.

Detailed Description

      Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the
      fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of
      subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by
      partial response (PR) or complete response (CR)

      Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer
      Center main campus):

        -  Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by
           11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase
           inhibitor (omeprazole) is hitting its target

        -  Obtain a prostate specific antigen response rate by adding the fatty acid synthase
           inhibitor omeprazole to the current "failing" taxane regimen. (16)

        -  Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS)
           at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.
    

Trial Arms

NameTypeDescriptionInterventions
Omeprazole Plus Standard of Care for Prostate Cancer RegimenExperimentalThis intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
  • Omeprazole 80 mg twice daily

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change Radiographic Response - RECIST 1.1
Time Frame:At 3, 6 and 9 months
Safety Issue:
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).

Secondary Outcome Measures

Measure:Fatty Acid Synthase Activity - Pre Omeprazole Use
Time Frame:At baseline
Safety Issue:
Description:Performed only on the first 10 participants by utilizing the 11C acetate tracer in the PET scan to evaluate the fatty acid synthase activity prior to omeprazole by examining changes in the values of standardized uptake. we will perform a two-sample t-test to see whether the change in SUV values is different between patients with an objective response versus those without an objective response.
Measure:Fatty Acid Synthase Activity - Post Omeprazole Use
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Evaluating the first 10 participants by utilizing the 11C acetate tracer in the PET scan to evaluate the fatty acid synthase activity prior to omeprazole by examining changes in the values of standardized uptake. we will perform a two-sample t-test to see whether the change in SUV values is different between patients with an objective response versus those without an objective response.
Measure:Prostate Specific Antigen (PSA) Progression
Time Frame:At baseline and up to approximately 2 years
Safety Issue:
Description:Investigators will collect PSA to determine whether PSA progression is positive or negative. Positive meaning that PSA slope is getting worse over time than it was prior to treatment and negative meaning PSA slope is improving after treatment when compared to baseline.
Measure:Prostate Specific Antigen (PSA) Response
Time Frame:At baseline and up to approximately 2 years
Safety Issue:
Description:Investigators will examine a PSA response rate (baseline on clinical definition of PSA response). In this analysis investigators will determine for each participant if they are a PSA responder (yes/no) and then using this data will estimate a 95% exact Clopper Pearson binomial interval for the PSA response rate.
Measure:Patient Reported Outcome - Pain
Time Frame:At baseline, 12 weeks, and Day 1 of every subsequent cycle (each cycle is 28 days) up to approximately 2 years
Safety Issue:
Description:Participants will report pain intensity at Cycle 1 Day 1 (baseline) compared to Cycle 5, Day 1 and Day 1 of every subsequent cycle on numeric scale of 0-to-10 (0 = no pain, 10 = worse imaginable pain). A paired t-test will be performed to determine whether the Pain score improved or worsened in patients after treatment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Wake Forest University Health Sciences

Last Updated

April 7, 2020