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NCT03361800 · ClinicalTrials.gov registry record · Early Phase 1
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
A Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03361800 is a Early Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 5 participants.
The verdict
NCT03361800, a Early Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only. Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its detection and treatment remains a major concern in women's healthcare. In particular, TNBC accounts for approximately 15-20% of all breast cancers. Research into treatment for breast cancer relies more and more on understanding how the cancer cells act when they are exposed to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which patients as a result may benefit the most from these drugs is not well known. Additional studies are required to determine the cells' reactions. The purpose of part 1 of this study is to better understand how TNBC tumors react to one particular cancer drug, entinostat. Entinostat is currently being studied across multiple clinical trials for the treatment of breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has not yet been FDA approved for the treatment of cancer. Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer drugs is a short-term preoperative window study. In this type of study, subjects receive a study drug a couple of days before surgery. Leftover tissue from surgery is then used to determine some of the effects that a study drug may have on the tumor. In this study, subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover tissue from this surgery will then be used to determine the effects entinostat has on tumor cells. For example, the study team will examine if the types of genes and proteins that the tumor expresses as a result of entinostat exposure increases or decreases the likelihood that the tumor will not continue to grow. A gene i
Interventions
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2019-10-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03361800
The ClinicalTrials.gov registry entry for NCT03361800 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Entinostat is the first listed.
NCT03361800 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03361800 about?
NCT03361800 is a clinical study titled "Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC". This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only. Approximately 246,660 cases of breast cancer...
What is the current status of trial NCT03361800?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2018-11-28. Estimated completion is 2019-10-11.
What interventions are being tested in trial NCT03361800?
The interventions under investigation include: Entinostat (DRUG).
Who is sponsoring clinical trial NCT03361800?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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