ACTIVE_NOT_RECRUITING

Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

Official Title

A Phase IB and Randomized Phase II Trial of Megestrol Acetate With or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Quick Facts

Study Start:2023-03-31
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05538897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer
  2. * Patients must have measurable disease according to RECIST version (v)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or MRI. Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
  3. * Patients may have received unlimited prior lines of therapy. If patient received prior hormonal therapy (e.g., megestrol acetate, medroxyprogesterone acetate, aromatase inhibitor, tamoxifen, fulvestrant) it must have completed at least 6 months prior to registration
  4. * Age \>= 18
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  6. * Platelets \>= 100,000/mcl within 14 days prior to registration
  7. * Absolute neutrophil count (ANC) \>= 1,500/mcl within 14 days prior to registration
  8. * Hemoglobin \>= 9 g/dL within 14 days prior to registration
  9. * Glomerular filtration rate (GFR) \>= 60 mL/min/1.73m\^2 measured using Cockcroft-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study within 14 days prior to registration
  10. * Total bilirubin =\< 1.5 x the upper limit of normal (ULN) within 14 days prior to registration
  11. * Patients with known Gilbert syndrome who have bilirubin =\< 3 x ULN may be enrolled
  12. * 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
  13. * Albumin \>= 3 g/dL within 14 days prior to registration
  14. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  15. * The effects of ipatasertib on the developing human fetus are unknown. For this reason and because AKT inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 28 days following the last dose of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately
  16. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  17. * For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection:
  18. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
  19. * Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
  20. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  21. * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  22. * Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of megestrol acetate or ipatasertib as judged by the treating physician
  23. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
  1. * Patients who have had prior treatment with an AKT inhibitor (Prior treatment with PI3K or mTOR inhibitors is allowed)
  2. * 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 study registration
  3. * Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
  4. * Patients with diabetes either requiring insulin therapy or with a baseline fasting glucose \> 160 mg/dL and/or high glycosylated hemoglobin A1c (HbA1c) (\> 8), suggesting poorly controlled diabetes. Fasting is defined as abstaining from food and drink (with the exception of water) for at least 8 hours
  5. * Patients who require chronic corticosteroid therapy of \> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease
  6. * Patients with grade 2 or greater uncontrolled or untreated hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 300 mg/dL)
  7. * Patients with a history of known or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
  8. * Patients with a history of or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction)
  9. * Patients with known clinically significant history of liver disease consistent with Child-Pugh class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
  10. * Patients with lung disease: Grade 2 or greater pneumonitis, grade 2 or greater interstitial 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
  11. * No active infection requiring parenteral antibiotics
  12. * Women who are pregnant or unwilling to discontinue nursing

Contacts and Locations

Principal Investigator

Michaela O Grinsfelder
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758
United States
Highlands Oncology Group
Springdale, Arkansas, 72762
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Sarasota Memorial Hospital-Venice
N. Venice, Florida, 34275
United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, 34236
United States
First Physicians Group-Sarasota
Sarasota, Florida, 34239
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, 34275
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
IU Health North Hospital
Carmel, Indiana, 46032
United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Community Hospital of Anaconda
Anaconda, Montana, 59711
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Community Medical Center
Missoula, Montana, 59804
United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
University of Rochester
Rochester, New York, 14642
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
United States
Summa Health System - Akron Campus
Akron, Ohio, 44304
United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
Geauga Hospital
Chardon, Ohio, 44024
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, 44145
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
United States
Forbes Hospital
Monroeville, Pennsylvania, 15146
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
United States
Women and Infants Hospital
Providence, Rhode Island, 02905
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Parkland Memorial Hospital
Dallas, Texas, 75235
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Michaela O Grinsfelder, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-31
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2027-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
  • FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
  • Metastatic Endometrial Endometrioid Adenocarcinoma
  • Recurrent Endometrial Endometrioid Adenocarcinoma