AzTrials
AzTrials

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaEarly Phase 1NCT03018249

Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer

A Early Phase 1 study testing Entinostat, Hysterectomy and Laboratory Biomarker Analysis in people with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 234 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Entinostat, Hysterectomy and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
234 sitesUnited States
Study dates
11 Oct 2017to 12 Mar 2021
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration; central pathology review will be required as part of the study but not for registration purposes
  • History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1); further protocol-specific assessments
  • The trial is open only to 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; the patient must be considered a suitable surgical candidate
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration
  • Formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage must be submitted along with the corresponding pathology report
  • Platelets >= 100,000/ul
Show all 12Show fewer
  • Granulocytes (ANC) >= 1,500/ul
  • Creatinine =< 1.6 mg/dl
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal
  • Bilirubin within institutional normal limits
  • The patient must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
  • Any patients of childbearing potential must have a negative pregnancy test

Who cannot join

  • Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma)
  • Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowed
  • Patients with ECOG performance grade of 4
  • Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders
  • Patients who have previously received systemic, radiation or other treatment for uterine cancer
  • Patients for whom formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage is unavailable
  • Patients must not have previously received a non Food and Drug Administration (FDA) approved histone deacetylase (HDAC) inhibitor in a clinical trial setting (entinostat, belinostat)
  • Patients must not be currently taking or have ever taken vorinostat (Zolinza, Merck), panobinostat (Farydak, Novartis) or romidepsin (Istodax, Gloucester Pharmaceuticals)

Trial locations and contacts

234 sites in 1 country.

234 sites in 1 country

United States234 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Joseph London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • Jewish Hospital Medical Center Northeast

    Louisville, Kentucky, 40245

  • McKee Medical Center

    Loveland, Colorado, 80539

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Community Medical Hospital

    Missoula, Montana, 59804

  • UPMC-Coraopolis/Heritage Valley Radiation Oncology

    Moon Township, Pennsylvania, 15108

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Hematology and Oncology Consultants PC

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Memorial GYN Plus

    Ooltewah, Tennessee, 37363

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado, 80138

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado, 81008

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of Rochester

    Rochester, New York, 14642

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • TidalHealth Nanticoke / Allen Cancer Center

    Seaford, Delaware, 19973

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Geisinger Medical Oncology-Selinsgrove

    Selinsgrove, Pennsylvania, 17870

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Jewish Hospital Medical Center South

    Shepherdsville, Kentucky, 40165

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Willis-Knighton Medical and Cancer Center

    Shreveport, Louisiana, 71103

  • Prisma Health Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Franciscan Research Center-Northwest Medical Plaza

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • National Jewish Health-Northern Hematology Oncology

    Thornton, Colorado, 80260

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • UPMC Uniontown Hospital Radiation Oncology

    Uniontown, Pennsylvania, 15401

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. To assess the response rate (as measured by cellular morphology and proliferation) and change in activated receptor levels with the addition of entinostat at the time of hysterectomy.

OUTLINE: Two arms were randomly allocated to eligible patients with equal probability.

ARM I: Patients receive medroxyprogesterone acetate intramuscularly (IM) on day 1 and undergo hysterectomy between days 21-24.

ARM II: Patients receive medroxyprogesterone acetate IM on day 1 and entinostat orally (PO) on days 1, 8, and 15. Patients undergo hysterectomy between days 21-24.

Being tested
Entinostat, Hysterectomy, Laboratory Biomarker Analysis, Medroxyprogesterone Acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntinostatDrug

    Also called HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275

    Given PO

  • HysterectomyProcedure or surgery

    Also called Hysterectomy NOS

    Undergo hysterectomy

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Medroxyprogesterone AcetateDrug

    Also called Amen, Aragest, Ciclotal, Clinofem

    Given IM

Study groups in NCT03018249
Study groupRoleWhat they receive
Arm I (medroxyprogesterone acetate, hysterectomy)Active comparatorPatients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
Receives: Procedure: Hysterectomy; Other: Laboratory Biomarker Analysis; Drug: Medroxyprogesterone Acetate
Arm II (medroxyprogesterone acetate, entinostat, hysterectomy)ExperimentalPatients receive medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Patients undergo hysterectomy between days 21-24.
Receives: Drug: Entinostat; Procedure: Hysterectomy; Other: Laboratory Biomarker Analysis; Drug: Medroxyprogesterone Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score)

    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 arm with entinostat relative to the medroxyprogesterone alone arm would be consistent with this hypothesis. Arm II was thought to result in higher scores which was expected to have a more favorable outcome when treated with MPA therapy.

    Measured: Specimens were collected at hysterectomy on day 21-24 and analyzed in batch.

Secondary outcomes (3)

  1. Percentage of Participants With a Histologic Response

    Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. A histologic response was defined as either the absence of identifiable adenocarcinoma in the hysterectomy specimen section (complete) or, subjectively, as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample (partial).

    Measured: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

  2. Percent of Participants With a Ki67 Response

    A response was defined as a decrease in Ki-67 protein expression in tumor from pre- to post-treatment.

    Measured: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

  3. The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE)

    Maximum grade of physician assessed adverse events reported during treatment and up to 45 days after surgery. Grades start with 1 which is considered mild through grade 5 which is death. Participants on this study had adverse event grades up to grade 3 which is considered moderately severe.

    Measured: Up to 45 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study start11 Oct 2017
  3. Primary completion18 Apr 2018
  4. Study completion12 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018249
Sponsor's protocol ID
NCI-2017-00058
Other IDs
NCI-2017-00058, NRG-GY011, NRG-GY011, NRG-GY011, U10CA180868
Status last verified
Nov 2021
First submitted
11 Jan 2017
Last updated
16 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Entinostat, Hysterectomy and Laboratory Biomarker Analysis in people with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 234 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score) (time frame: Specimens were collected at hysterectomy on day 21-24 and analyzed in batch.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.

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