Phase
Condition
Adenocarcinoma
Endometrial Cancer
Treatment
Magnetic Resonance Imaging
Biospecimen Collection
Ipatasertib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrialcancer
Patients must have measurable disease according to RECIST version (v)1.1. Measurabledisease is defined as at least one lesion that can be accurately measured in atleast one dimension (longest diameter to be recorded). Each lesion must be >= 10 mmwhen measured by CT or MRI. Lymph nodes must be >= 15 mm in short axis when measuredby CT or MRI. Previously irradiated lesions can be considered as measurable diseaseonly if progressive disease has been unequivocally documented at that site sinceradiation
Patients may have received unlimited prior lines of therapy. If patient receivedprior hormonal therapy (e.g., megestrol acetate, medroxyprogesterone acetate,aromatase inhibitor, tamoxifen, fulvestrant) it must have completed at least 6months prior to registration
Age >= 18
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Platelets >= 100,000/mcl within 14 days prior to registration
Absolute neutrophil count (ANC) >= 1,500/mcl within 14 days prior to registration
Hemoglobin >= 9 g/dL within 14 days prior to registration
Glomerular filtration rate (GFR) >= 60 mL/min/1.73m^2 measured using Cockcroft-Gaultequation or the estimated glomerular filtration rate from the Modification of Dietin Renal Disease Study within 14 days prior to registration
Total bilirubin =< 1.5 x the upper limit of normal (ULN) within 14 days prior toregistration
Patients with known Gilbert syndrome who have bilirubin =< 3 x ULN may beenrolled
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN within 14 days prior to registration
Albumin >= 3 g/dL within 14 days prior to registration
Patients with known history or current symptoms of cardiac disease, or history oftreatment with cardiotoxic agents, should have a clinical risk assessment of cardiacfunction using the New York Heart Association Functional Classification. To beeligible for this trial, patients should be class 2B or better
The effects of ipatasertib on the developing human fetus are unknown. For thisreason and because AKT inhibitor agents as well as other therapeutic agents used inthis trial are known to be teratogenic, participants of child-bearing potential mustagree to use adequate contraception (hormonal or barrier method of birth control;abstinence) during study therapy and for 28 days following the last dose of studytherapy. Should a participant become pregnant or suspect pregnancy whileparticipating in this study, they should inform their treating physician immediately
Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial
For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV),and/or hepatitis C virus (HCV) infection:
HIV-infected patients on effective anti-retroviral therapy with undetectableviral load within 6 months of registration are eligible for this trial
Patients with evidence of chronic hepatitis B virus (HBV) infection must havean undetectable HBV viral load on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have beentreated and cured. For patients with HCV infection who are currently ontreatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging aftercentral nervous system (CNS)-directed therapy shows no evidence of progression
Patients must be able to swallow and retain oral medications and not havegastrointestinal illnesses that would preclude absorption of megestrol acetate oripatasertib as judged by the treating physician
The patient or a legally authorized representative must provide study-specificinformed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion
Exclusion Criteria:
Patients who have had prior treatment with an AKT inhibitor (Prior treatment withPI3K or mTOR inhibitors is allowed)
Patients who have received treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to studyregistration
Because the lists of these agents are constantly changing, it is important toregularly consult a frequently-updated medical reference. As part of theenrollment/informed consent procedures, the patient will be counseled on therisk of interactions with other agents, and what to do if new medications needto be prescribed or if the patient is considering a new over-the-countermedicine or herbal product
Patients with diabetes either requiring insulin therapy or with a baseline fastingglucose > 160 mg/dL and/or high glycosylated hemoglobin A1c (HbA1c) (> 8),suggesting poorly controlled diabetes. Fasting is defined as abstaining from foodand drink (with the exception of water) for at least 8 hours
Patients who require chronic corticosteroid therapy of > 10 mg of prednisone per dayor an equivalent dose of other anti-inflammatory corticosteroids orimmunosuppressant agents for a chronic disease
Patients with grade 2 or greater uncontrolled or untreated hypercholesterolemia (> 300 mg/dL) or hypertriglyceridemia (> 300 mg/dL)
Patients with a history of known or active inflammatory bowel disease (e.g., Crohndisease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
Patients with a history of or presence of an abnormal electrocardiogram (ECG) thatis clinically significant in the investigator's opinion (including complete leftbundle branch block, second- or third-degree heart block, or evidence of priormyocardial infarction)
Patients with known clinically significant history of liver disease consistent withChild-Pugh class B or C, including active viral or other hepatitis, current drug oralcohol abuse, or cirrhosis
Patients with lung disease: Grade 2 or greater pneumonitis, grade 2 or greaterinterstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis,aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) within the past 6 months
No active infection requiring parenteral antibiotics
Women who are pregnant or unwilling to discontinue nursing
Study Design
Study Description
Connect with a study center
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United StatesSite Not Available
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United StatesSite Not Available
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas 72703
United StatesSite Not Available
Highlands Oncology Group - Rogers
Rogers, Arkansas 72758
United StatesSite Not Available
Highlands Oncology Group
Springdale, Arkansas 72762
United StatesSite Not Available
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United StatesSite Not Available
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United StatesSite Not Available
Sarasota Memorial Hospital-Venice
N. Venice, Florida 34275
United StatesSite Not Available
First Physicians Group-Sarasota
Sarasota, Florida 34239
United StatesSite Not Available
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Florida Cancer Specialists - Venice Healthpark
Venice, Florida 34292
United StatesActive - Recruiting
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida 34275
United StatesSite Not Available
Augusta University Medical Center
Augusta, Georgia 30912
United StatesSite Not Available
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United StatesSite Not Available
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United StatesSite Not Available
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United StatesSite Not Available
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United StatesSite Not Available
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United StatesSite Not Available
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United StatesSite Not Available
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
United StatesSite Not Available
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United StatesSite Not Available
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Illinois
Chicago, Illinois 60612
United StatesSite Not Available
Carle at The Riverfront
Danville, Illinois 61832
United StatesSite Not Available
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United StatesSite Not Available
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United StatesSite Not Available
Decatur Memorial Hospital
Decatur, Illinois 62526
United StatesSite Not Available
Carle Physician Group-Effingham
Effingham, Illinois 62401
United StatesSite Not Available
Crossroads Cancer Center
Effingham, Illinois 62401
United StatesSite Not Available
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United StatesSite Not Available
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United StatesSite Not Available
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United StatesSite Not Available
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United StatesSite Not Available
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United StatesSite Not Available
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United StatesSite Not Available
Memorial Medical Center
Springfield, Illinois 62781
United StatesActive - Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United StatesSite Not Available
Springfield Clinic
Springfield, Illinois 62702
United StatesSite Not Available
Springfield Memorial Hospital
Springfield, Illinois 62781
United StatesSite Not Available
Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United StatesSite Not Available
IU Health North Hospital
Carmel, Indiana 46032
United StatesSite Not Available
Parkview Regional Medical Center
Fort Wayne, Indiana 46845
United StatesSite Not Available
Goshen Center for Cancer Care
Goshen, Indiana 46526
United StatesSite Not Available
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Memorial Hospital of South Bend
South Bend, Indiana 46601
United StatesSite Not Available
Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
United StatesActive - Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United StatesSite Not Available
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United StatesSite Not Available
Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
United StatesActive - Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United StatesSite Not Available
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Cancer Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
United StatesSite Not Available
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
Harold Alfond Center for Cancer Care
Augusta, Maine 04330
United StatesSite Not Available
Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
United StatesActive - Recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
United StatesSite Not Available
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United StatesSite Not Available
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Bronson Battle Creek
Battle Creek, Michigan 49017
United StatesSite Not Available
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
United StatesSite Not Available
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United StatesSite Not Available
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United StatesSite Not Available
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United StatesSite Not Available
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
United StatesSite Not Available
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United StatesSite Not Available
Corewell Health Reed City Hospital
Reed City, Michigan 49677
United StatesSite Not Available
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United StatesSite Not Available
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
United StatesSite Not Available
Munson Medical Center
Traverse City, Michigan 49684
United StatesSite Not Available
University of Michigan Health - West
Wyoming, Michigan 49519
United StatesSite Not Available
Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesSite Not Available
Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesSite Not Available
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesSite Not Available
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Regions Hospital
Saint Paul, Minnesota 55101
United StatesSite Not Available
United Hospital
Saint Paul, Minnesota 55102
United StatesSite Not Available
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
United StatesSite Not Available
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
United StatesSite Not Available
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri 65109
United StatesSite Not Available
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United StatesSite Not Available
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United StatesSite Not Available
Mercy Hospital South
Saint Louis, Missouri 63128
United StatesSite Not Available
Mercy Hospital Springfield
Springfield, Missouri 65804
United StatesSite Not Available
Community Hospital of Anaconda
Anaconda, Montana 59711
United StatesSite Not Available
Billings Clinic Cancer Center
Billings, Montana 59101
United StatesSite Not Available
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United StatesSite Not Available
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United StatesSite Not Available
Community Medical Center
Missoula, Montana 59804
United StatesSite Not Available
Cooper Hospital University Medical Center
Camden, New Jersey 08103
United StatesSite Not Available
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United StatesSite Not Available
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
United StatesSite Not Available
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
United StatesSite Not Available
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
State University of New York Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United StatesSite Not Available
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
United StatesSite Not Available
Summa Health System - Akron Campus
Akron, Ohio 44304
United StatesSite Not Available
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
United StatesSite Not Available
Miami Valley Hospital South
Centerville, Ohio 45459
United StatesSite Not Available
Geauga Hospital
Chardon, Ohio 44024
United StatesSite Not Available
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
United StatesSite Not Available
Case Western Reserve University
Cleveland, Ohio 44106
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesSite Not Available
Miami Valley Hospital
Dayton, Ohio 45409
United StatesSite Not Available
Miami Valley Hospital North
Dayton, Ohio 45415
United StatesSite Not Available
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
United StatesSite Not Available
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
United StatesSite Not Available
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
United StatesSite Not Available
Upper Valley Medical Center
Troy, Ohio 45373
United StatesSite Not Available
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
United StatesSite Not Available
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United StatesSite Not Available
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
United StatesSite Not Available
Forbes Hospital
Monroeville, Pennsylvania 15146
United StatesSite Not Available
NRG Oncology
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
United StatesSite Not Available
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
Women and Infants Hospital
Providence, Rhode Island 02905
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United StatesSite Not Available
Parkland Memorial Hospital
Dallas, Texas 75235
United StatesSite Not Available
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United StatesSite Not Available
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
United StatesSite Not Available
M D Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United StatesSite Not Available
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United StatesSite Not Available
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United StatesSite Not Available
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United StatesSite Not Available
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
United StatesSite Not Available
Carilion Clinic Gynecological Oncology
Roanoke, Virginia 24016
United StatesActive - Recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24033
United StatesSite Not Available
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
United StatesSite Not Available
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
United StatesSite Not Available
Swedish Medical Center-First Hill
Seattle, Washington 98122
United StatesSite Not Available
West Virginia University Charleston Division
Charleston, West Virginia 25304
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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