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NCT03018249 · ClinicalTrials.gov registry record · Early Phase 1
Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT03018249: Completed Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03018249 is a Early Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03018249, a Early Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This randomized surgical window trial evaluates the effect of adding entinostat to medroxyprogesterone acetate before surgery works on progesterone receptors on endometrioid endometrial tumors. Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving medroxyprogesterone acetate with or without entinostat may effect tumors from endometrioid endometrial cancer.
Primary Outcome
The H-score is defined as the percent cells staining positive (0-100) multiplied by the staining intensity (0, 1, 2 or 3) measured in the tumor by immunohistochemistry and averaged over 3 reviewers. This score can range from 0 to 300. In general, PRs are expected to decrease in response to medroxyprogesterone acetate. It was hypothesized that entinostat would mitigate the decrease in PR relative to the medroxyprogesterone acetate only arm post treatment. Higher PR H-scores post treatment in the
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Entinostat
- PROCEDURE Hysterectomy
- DRUG Medroxyprogesterone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2021-03-12 |
| Phase | Early Phase 1 |
What the finished NCT03018249 record still lists
NCT03018249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03018249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03018249 about?
NCT03018249 is a clinical study titled "Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer". This randomized surgical window trial evaluates the effect of adding entinostat to medroxyprogesterone acetate before surgery works on progesterone receptors on endometrioid endometrial tumors. Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally. Entinostat may stop th...
What is the current status of trial NCT03018249?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2017-10-11. Estimated completion is 2021-03-12.
What interventions are being tested in trial NCT03018249?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Entinostat (DRUG), Hysterectomy (PROCEDURE), Medroxyprogesterone Acetate (DRUG).
Who is sponsoring clinical trial NCT03018249?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03018249's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,468 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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