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NCT04337580 · ClinicalTrials.gov registry record · Phase 2
Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
A Phase 2 study of Prostate Cancer and Refractory Cancer, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT04337580: Recruiting Phase 2 study of Prostate Cancer and Refractory Cancer, sponsored by Wake Forest University Health Sciences.
NCT04337580 is a Phase 2 study of Prostate Cancer and Refractory Cancer that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 50 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04337580, a Phase 2 study of Prostate Cancer and Refractory Cancer, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Omeprazole 80 mg twice daily
Study Locations (2)
North Carolina
- W.G. Bill Hefner VA Medical Center - Salisbury
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT04337580 shows while recruiting
NCT04337580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Omeprazole 80 mg twice daily is the first listed.
NCT04337580 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04337580 about?
NCT04337580 is a clinical study titled "Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer". 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.
What is the current status of trial NCT04337580?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-03-05. Estimated completion is 2028-03.
What conditions does trial NCT04337580 study?
This clinical trial studies the following conditions: Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic Cancer.
What interventions are being tested in trial NCT04337580?
The interventions under investigation include: Omeprazole 80 mg twice daily (DRUG).
Who is sponsoring clinical trial NCT04337580?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04337580 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04337580's enrollment target sits among peer trials
50 469th of 735 higher than 247 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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