NRG-GY011

Terminated

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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

Principal Investigator

Linda Duska

Status

Terminated

Open to Accrual

August 25, 2017

Closed to Accrual

February 9, 2018

Terminated

March 12, 2020

Terminated

March 12, 2021


Disease Site

Gynecologic [GY] Uterine Corpus

Phase

II

Developmental Therapeutics

No

Primary Objective

To determine whether the addition of the histone deacetylase inhibitor, entinostat, in combination with medroxyprogesterone acetate in the pre-operative setting results in up-regulation of activated progesterone receptors (PR) compared to medroxyprogesterone acetate alone.

Patient Population

Women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment to include removal of the uterine corpus via any surgical modality.

 

Target Accrual

50

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.