CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 50 enrolled
Drug / intervention
Entinostat +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03018249
NCT03018249Early Ph 1Completed

A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus

National Cancer Institute (NCI)·interventional·Posted Jan 12, 2017·Updated Nov 16, 2021

In Brief

A Early Phase 1 clinical trial evaluating Entinostat, Hysterectomy, and 2 other interventions for FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and 2 related conditions. Completed, enrolled 50 participants across 234 sites.

Detailed 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.

Study Details

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartOct 11, 2017
Primary CompletionApr 18, 2018
Study CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.5 years ago

Interventions

Entinostatdrug

Given PO

Hysterectomyprocedure

Undergo hysterectomy

Laboratory Biomarker Analysisother

Correlative studies

Medroxyprogesterone Acetatedrug

Given IM