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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03018249
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase II trial studies how well medroxyprogesterone acetate with or without entinostat before surgery works in treating patients with endometrioid endometrial cancer. 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. Given medroxyprogesterone acetate with or without entinostat may work better in treating patients with endometrioid endometrial cancer.

Condition or disease Intervention/treatment Phase
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma Uterine Corpus Adenosarcoma Drug: Entinostat Procedure: Hysterectomy Other: Laboratory Biomarker Analysis Drug: Medroxyprogesterone Acetate Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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: Patients are randomized into 1 of 2 arms.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Arm I (medroxyprogesterone acetate, hysterectomy)
Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
Procedure: Hysterectomy
Undergo hysterectomy

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Medroxyprogesterone Acetate
Given IM
Other Names:
  • Amen
  • Aragest
  • Ciclotal
  • Clinofem
  • Clinovir
  • Cycrin
  • Depo-Clinovir
  • Depo-Provera
  • Depot-Medroxyprogestereone Acetate
  • Farlutal
  • G-Farlutal
  • Gestapuran
  • Hysron
  • Lutoral
  • Medroxyprogesterone 17-Acetate
  • Medroxyprogesteroni Acetas
  • Methylacetoxyprogesterone
  • Metipregnone
  • MPA
  • Nadigest
  • Nadigest (vet)
  • Nidaxin
  • Nidaxin (vet)
  • Oragest
  • Perlutex
  • Prodasone
  • Provera
  • Sodelut G
  • Veramix

Experimental: Arm II (medroxyprogesterone acetate, entinostat, hysterectomy)
Patients receive medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Patients undergo hysterectomy between days 21-24.
Drug: Entinostat
Given PO
Other Names:
  • HDAC inhibitor SNDX-275
  • MS 27-275
  • MS-275
  • SNDX-275

Procedure: Hysterectomy
Undergo hysterectomy

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Medroxyprogesterone Acetate
Given IM
Other Names:
  • Amen
  • Aragest
  • Ciclotal
  • Clinofem
  • Clinovir
  • Cycrin
  • Depo-Clinovir
  • Depo-Provera
  • Depot-Medroxyprogestereone Acetate
  • Farlutal
  • G-Farlutal
  • Gestapuran
  • Hysron
  • Lutoral
  • Medroxyprogesterone 17-Acetate
  • Medroxyprogesteroni Acetas
  • Methylacetoxyprogesterone
  • Metipregnone
  • MPA
  • Nadigest
  • Nadigest (vet)
  • Nidaxin
  • Nidaxin (vet)
  • Oragest
  • Perlutex
  • Prodasone
  • Provera
  • Sodelut G
  • Veramix




Primary Outcome Measures :
  1. Mean post-treatment tumor progesterone receptor score [ Time Frame: Up to 3 years ]
    The percent cells staining positive multiplied by the staining intensity will be compared between treatment arms to evaluate the association of the addition of entinostat treatment on tumor progesterone receptor expression. A treatment difference in the distribution of post-treatment progesterone receptor scores will be tested using a Mann-Whitney test. An analysis of covariance model could be used to test the treatment difference while adjusting for pre-treatment progesterone receptor scores or testing the mean post-treatment - pre-treatment differences could be compared between arms with a T test.


Secondary Outcome Measures :
  1. Proportion of patients with a histologic tumor response (complete or partial) [ Time Frame: Up to 3 years ]
    Will compare the difference in the proportion of patients with a histologic tumor response (complete or partial) between treatment arms.

  2. Mean post-treatment tumor Ki67 score [ Time Frame: Up to 3 years ]
    The percent cells staining positive multiplied by the staining intensity will be compared between treatment arms. A treatment difference in the distribution of post-treatment tumor Ki67 scores will be tested using a Mann-Whitney test. An analysis of covariance model could be used to test the treatment difference while adjusting for pre-treatment tumor Ki67 scores or testing the mean post-treatment - pre-treatment differences could be compared between arms with a T test. A confidence interval around the estimate of the treatment difference in the proportion with a histologic response will be constructed. Correlation between Ki67 and histologic response will be evaluated by treatment team.

  3. Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 45 days after surgery ]
    The frequency and maximum severity of acute drug emergent and post-surgical adverse events will be tabulated by treatment arm.


Other Outcome Measures:
  1. Mean post-treatment tumor estrogen receptor score [ Time Frame: Up to 3 years ]
  2. Co-expression of PR, Ki67, and p21 [ Time Frame: Up to 3 years ]
    Will be compared between the treatment arms.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018249


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Locations
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United States, Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States, 71913
United States, California
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Denver Health Medical Center
Denver, Colorado, United States, 80204
National Jewish Health-Main Campus
Denver, Colorado, United States, 80206
The Women's Imaging Center
Denver, Colorado, United States, 80209
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Mercy Medical Center
Durango, Colorado, United States, 81301
Southwest Oncology PC
Durango, Colorado, United States, 81301
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
Mountain Blue Cancer Care Center
Golden, Colorado, United States, 80401
National Jewish Health-Western Hematology Oncology
Golden, Colorado, United States, 80401
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States, 81008
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, United States, 80260
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States, 80260
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Florida
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Idaho
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
United States, Indiana
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Greater Regional Medical Center
Creston, Iowa, United States, 50801
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Flaget Memorial Hospital
Bardstown, Kentucky, United States, 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States, 40701
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States, 40504
Saint Joseph Hospital East
Lexington, Kentucky, United States, 40509
Saint Joseph London
London, Kentucky, United States, 40741
Jewish Hospital
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, United States, 40215
Jewish Hospital Medical Center Northeast
Louisville, Kentucky, United States, 40245
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, United States, 40165
United States, Louisiana
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Willis-Knighton Medical and Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Fairview Maple Grove Medical Center
Maple Grove, Minnesota, United States, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, United States, 55092
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States, 63011
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Washington
Washington, Missouri, United States, 63090
United States, Montana
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
Heartland Hematology and Oncology
Kearney, Nebraska, United States, 68845
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Hematology and Oncology Consultants PC
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States, 45255
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States, 44903
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania, United States, 15108
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States, 17901
Community Medical Center
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, United States, 17870
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina, United States, 29325
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States, 37067
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, United States, 37343
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Memorial GYN Plus
Ooltewah, Tennessee, United States, 37363
United States, Texas
Saint Joseph Regional Cancer Center
Bryan, Texas, United States, 77802
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Harrison Medical Center
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Saint Elizabeth Hospital
Enumclaw, Washington, United States, 98022
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
United States, Wisconsin
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
United States, Wyoming
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States, 82001
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
National Cancer Institute (NCI)
NRG Oncology
Investigators
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Principal Investigator: Linda R Duska NRG Oncology

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03018249     History of Changes
Other Study ID Numbers: NCI-2017-00058
NCI-2017-00058 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GY011
NRG-GY011 ( Other Identifier: NRG Oncology )
NRG-GY011 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Entinostat
Adenocarcinoma
Carcinoma, Endometrioid
Adenosarcoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs