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NCT02595372 · ClinicalTrials.gov registry record · Phase 2
Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy
A Phase 2 study, sponsored by Kathy Miller.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02595372 is a Phase 2 study that has completed, run by Kathy Miller. The registered enrollment target is 42 participants.
The verdict
NCT02595372, a Phase 2 study, has completed, sponsored by Kathy Miller.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
In preliminary laboratory science studies, the investigators show that proton pump inhibitors (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer cell survival. A preliminary retrospective study shows that PPI usage in breast cancer patients during chemotherapy significantly improved overall survival. The impact was most striking in patients with triple negative breast cancer (TNBC). Thus, PPIs may be repositioned as safe and effective breast cancer drugs to enhance the effect of chemotherapy. Many of the hurdles that slow progress from target, to lead compound, to investigational agent, to standard therapy are not barriers for the PPIs. The PPIs are FDA-approved, chronically used, and well tolerated so the investigators can move quickly from the laboratory to a proof of concept clinical trial. Incorporating the PPIs into standard care will require more than the investigators propose here, but the investigators have already plotted the additional steps needed to truly impact patient care. If successful, the data gathered in this proposal will lend support to and guide development of a definitive randomized trial.
Interventions
- DRUG Omeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02595372
The ClinicalTrials.gov registry entry for NCT02595372 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kathy Miller, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omeprazole is the first listed.
NCT02595372 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02595372 about?
NCT02595372 is a clinical study titled "Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy". In preliminary laboratory science studies, the investigators show that proton pump inhibitors (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer cell survival. A preliminary retrospective study shows that PPI usage in breast cancer patients during chemotherapy significantl...
What is the current status of trial NCT02595372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-11-12. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT02595372?
The interventions under investigation include: Omeprazole (DRUG).
Who is sponsoring clinical trial NCT02595372?
This trial is sponsored by Kathy Miller, which has 8 total clinical trials registered on ClinicalTrials.gov.
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