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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer - 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 - 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 - 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-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study within 14 days prior to registration - Total bilirubin =< 1.5 x the upper limit of normal (ULN) within 14 days prior to registration - Patients with known Gilbert syndrome who have bilirubin =< 3 x ULN may be enrolled - 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 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 - 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 - 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 - 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 undetectable viral load within 6 months of registration are eligible for this trial - Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated - 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 - Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression - 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 - 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

Exclusion Criteria

  • Patients who have had prior treatment with an AKT inhibitor (Prior treatment with PI3K 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 study registration - 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 - 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 - 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 - 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., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis) - 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) - 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 - 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 - No active infection requiring parenteral antibiotics - Women who are pregnant or unwilling to discontinue nursing

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase Ib (megestrol acetate, ipatasertib) 		Patients receive megestrol acetate PO QD on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Drug: Ipatasertib
    Given PO
    Other names:
    • GDC 0068
    • GDC-0068
    • GDC0068
    • RG 7440
    • RG-7440
    • RG7440
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Megestrol Acetate
    Given PO
    Other names:
    • 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
    • 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
    • 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
    • 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
    • BDH 1298
    • BDH-1298
    • Maygace
    • Megace
    • Megestat
    • Megestil
    • Niagestin
    • Ovaban
    • Pallace
    • SC 10363
    • SC-10363
Active Comparator
Phase II (megestrol acetate) 		Arm I: Patients receive megestrol acetate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Megestrol Acetate
    Given PO
    Other names:
    • 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
    • 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
    • 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
    • 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
    • BDH 1298
    • BDH-1298
    • Maygace
    • Megace
    • Megestat
    • Megestil
    • Niagestin
    • Ovaban
    • Pallace
    • SC 10363
    • SC-10363
Experimental
Phase II (megestrol acetate, ipatasertib) 		Arm II: Patients receive megestrol acetate PO QD on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Drug: Ipatasertib
    Given PO
    Other names:
    • GDC 0068
    • GDC-0068
    • GDC0068
    • RG 7440
    • RG-7440
    • RG7440
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Megestrol Acetate
    Given PO
    Other names:
    • 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
    • 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
    • 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
    • 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
    • BDH 1298
    • BDH-1298
    • Maygace
    • Megace
    • Megestat
    • Megestil
    • Niagestin
    • Ovaban
    • Pallace
    • SC 10363
    • SC-10363

Recruiting Locations

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas 72703
Contact:
Site Public Contact
479-872-8100
research@hogonc.com

Highlands Oncology Group - Rogers
Rogers, Arkansas 72758
Contact:
Site Public Contact
479-872-8130
research@hogonc.com

Highlands Oncology Group
Springdale, Arkansas 72762
Contact:
Site Public Contact
479-872-8130
research@hogonc.com

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
Contact:
Site Public Contact
352-273-8010
cancer-center@ufl.edu

Sarasota Memorial Hospital-Venice
N. Venice, Florida 34275
Contact:
Site Public Contact
941-261-9000

Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
Contact:
Site Public Contact
941-957-1000

First Physicians Group-Sarasota
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-8383

Sarasota Memorial Hospital
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-2225

Florida Cancer Specialists - Venice Pinebrook
Venice, Florida 34275
Contact:
Site Public Contact
239-274-9930
ClinicalTrials@FLCancer.com

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
nctnprogram_rhlccc@northwestern.edu

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

IU Health North Hospital
Carmel, Indiana 46032
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Parkview Regional Medical Center
Fort Wayne, Indiana 46845
Contact:
Site Public Contact
877-784-4673

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-241-3305

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Harold Alfond Center for Cancer Care
Augusta, Maine 04330
Contact:
Site Public Contact
207-626-4855

MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
slusserb@med.umich.edu

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
Contact:
Site Public Contact
612-624-2620

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440

MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri 65109
Contact:
Site Public Contact
573-632-4851
amy.franken@health.missouri.edu

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Cooper Hospital University Medical Center
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
Contact:
Site Public Contact
800-804-9376

Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
Contact:
Site Public Contact
800-804-9376

Summa Health System - Akron Campus
Akron, Ohio 44304
Contact:
Site Public Contact
330-375-4221
cancerresearch@summahealth.org

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Geauga Hospital
Chardon, Ohio 44024
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
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866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
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800-293-5066
Jamesline@osumc.edu

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
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937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
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937-569-7515

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

Upper Valley Medical Center
Troy, Ohio 45373
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937-528-2900
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UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
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800-641-2422
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
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405-271-8777
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Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
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918-505-3200

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
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Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Providence Portland Medical Center
Portland, Oregon 97213
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503-215-2614
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Providence Saint Vincent Medical Center
Portland, Oregon 97225
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503-215-2614
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Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
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412-359-3043
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Forbes Hospital
Monroeville, Pennsylvania 15146
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412-858-7746

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-600-9151
ONCTrialNow@jefferson.edu

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
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877-284-2000

West Penn Hospital
Pittsburgh, Pennsylvania 15224
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412-578-5000

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
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Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
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Women and Infants Hospital
Providence, Rhode Island 02905
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Parkland Memorial Hospital
Dallas, Texas 75235
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214-590-5582
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
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214-648-7097
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UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
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Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
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713-566-5000

M D Anderson Cancer Center
Houston, Texas 77030
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UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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888-424-2100
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University of Virginia Cancer Center
Charlottesville, Virginia 22908
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434-243-6303
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
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CTOclinops@vcu.edu

Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24033
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540-985-8510

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
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206-215-3086
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Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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206-215-3086
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Swedish Medical Center-First Hill
Seattle, Washington 98122
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206-215-3086
PCRC-NCORP@Swedish.org

West Virginia University Charleston Division
Charleston, West Virginia 25304
Contact:
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304-388-9944

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Contact:
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800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Contact:
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800-622-8922
clinicaltrials@cancer.wisc.edu

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

More Details

NCT ID
NCT05538897
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid adenocarcinoma of the endometrium. (Phase II) III. Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone. (Phase II) SECONDARY OBJECTIVES: I. Compare objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two arms. II. Examine the pharmacokinetics of ipatasertib + megestrol acetate to assess potential drug-drug interactions. III. Assess the association between biomarkers and response to therapy. EXPLORATORY OBJECTIVE: I. Explore whether pS6/total S6 and pPRAS40/total PRAS40 expression is impacted by the use of ipatasertib and megestrol acetate. OUTLINE: This is a phase Ib, dose de-escalation study of ipatasertib followed by a phase II study. PHASE Ib: Patients receive megestrol acetate orally (PO) once daily (QD) on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT) or magnetic resonance imaging (MRI) during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Patients receive megestrol acetate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial. ARM II: Patients receive megestrol acetate PO QD on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial. After completion of study treatment, patients are followed up at 30 days for the phase I study. Patients are followed up every 3 months for 2 years, then every 6 months for 3 years for the phase II study.

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