Trial Title:
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
NCT ID:
NCT05538897
Condition:
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Metastatic Endometrial Endometrioid Adenocarcinoma
Recurrent Endometrial Endometrioid Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Endometrial Neoplasms
Carcinoma, Endometrioid
Recurrence
Megestrol
Megestrol Acetate
Ipatasertib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Phase II (megestrol acetate)
Arm group label:
Phase II (megestrol acetate, ipatasertib)
Arm group label:
Phase Ib (megestrol acetate, ipatasertib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Phase II (megestrol acetate)
Arm group label:
Phase II (megestrol acetate, ipatasertib)
Arm group label:
Phase Ib (megestrol acetate, ipatasertib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Ipatasertib
Description:
Given PO
Arm group label:
Phase II (megestrol acetate, ipatasertib)
Arm group label:
Phase Ib (megestrol acetate, ipatasertib)
Other name:
GDC 0068
Other name:
GDC-0068
Other name:
GDC0068
Other name:
RG 7440
Other name:
RG-7440
Other name:
RG7440
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Phase II (megestrol acetate)
Arm group label:
Phase II (megestrol acetate, ipatasertib)
Arm group label:
Phase Ib (megestrol acetate, ipatasertib)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
Megestrol Acetate
Description:
Given PO
Arm group label:
Phase II (megestrol acetate)
Arm group label:
Phase II (megestrol acetate, ipatasertib)
Arm group label:
Phase Ib (megestrol acetate, ipatasertib)
Other name:
17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
Other name:
17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
Other name:
6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
Other name:
6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
Other name:
BDH 1298
Other name:
BDH-1298
Other name:
Maygace
Other name:
Megace
Other name:
Megestat
Other name:
Megestil
Other name:
Niagestin
Other name:
Ovaban
Other name:
Pallace
Other name:
SC 10363
Other name:
SC-10363
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner University Medical Center - Tucson
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
UACC-IIT@uacc.arizona.edu
Investigator:
Last name:
Setsuko K. Chambers
Email:
Principal Investigator
Facility:
Name:
University of Arizona Cancer Center-North Campus
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
UACC-IIT@uacc.arizona.edu
Investigator:
Last name:
Setsuko K. Chambers
Email:
Principal Investigator
Facility:
Name:
Highlands Oncology Group - Fayetteville
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
479-872-8100
Email:
research@hogonc.com
Investigator:
Last name:
Joseph T. Beck
Email:
Principal Investigator
Facility:
Name:
Highlands Oncology Group - Rogers
Address:
City:
Rogers
Zip:
72758
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
479-872-8130
Email:
research@hogonc.com
Investigator:
Last name:
Joseph T. Beck
Email:
Principal Investigator
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
479-872-8130
Email:
research@hogonc.com
Investigator:
Last name:
Joseph T. Beck
Email:
Principal Investigator
Facility:
Name:
University of California Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
916-734-3089
Investigator:
Last name:
Nancy T. Nguyen
Email:
Principal Investigator
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-848-0650
Investigator:
Last name:
Bradley R. Corr
Email:
Principal Investigator
Facility:
Name:
University of Florida Health Science Center - Gainesville
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
352-273-8010
Email:
cancer-center@ufl.edu
Investigator:
Last name:
Merry J. Markham
Email:
Principal Investigator
Facility:
Name:
Sarasota Memorial Hospital-Venice
Address:
City:
N. Venice
Zip:
34275
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
941-261-9000
Investigator:
Last name:
Beverly Long
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - Sarasota Downtown
Address:
City:
Sarasota
Zip:
34236
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
941-957-1000
Investigator:
Last name:
Beverly Long
Email:
Principal Investigator
Facility:
Name:
First Physicians Group-Sarasota
Address:
City:
Sarasota
Zip:
34239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
941-917-8383
Investigator:
Last name:
Beverly Long
Email:
Principal Investigator
Facility:
Name:
Sarasota Memorial Hospital
Address:
City:
Sarasota
Zip:
34239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
941-917-2225
Investigator:
Last name:
Beverly Long
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - Venice Healthpark
Address:
City:
Venice
Zip:
34292
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-339-5294
Email:
Roster@nrgoncology.org
Investigator:
Last name:
Beverly Long
Email:
Principal Investigator
Facility:
Name:
Augusta University Medical Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
706-721-2388
Email:
ga_cares@augusta.edu
Investigator:
Last name:
Sharad A. Ghamande
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Boise
Address:
City:
Boise
Zip:
83712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Fruitland
Address:
City:
Fruitland
Zip:
83619
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Meridian
Address:
City:
Meridian
Zip:
83642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Nampa
Address:
City:
Nampa
Zip:
83687
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Kishwaukee
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Grayslake Outpatient Center
Address:
City:
Grayslake
Zip:
60030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1102
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Lake Forest Hospital
Address:
City:
Lake Forest
Zip:
60045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
cancertrials@northwestern.edu
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Orland Park
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
nctnprogram_rhlccc@northwestern.edu
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-545-7929
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-444-7541
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Memorial Hospital
Address:
City:
Springfield
Zip:
62781
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-528-7541
Email:
pallante.beth@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Emma Barber
Email:
Principal Investigator
Facility:
Name:
IU Health North Hospital
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
317-278-5632
Email:
iutrials@iu.edu
Investigator:
Last name:
Lisa M. Landrum
Email:
Principal Investigator
Facility:
Name:
Indiana University/Melvin and Bren Simon Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
317-278-5632
Email:
iutrials@iu.edu
Investigator:
Last name:
Lisa M. Landrum
Email:
Principal Investigator
Facility:
Name:
Memorial Hospital of South Bend
Address:
City:
South Bend
Zip:
46601
Country:
United States
Status:
Suspended
Facility:
Name:
Mission Cancer and Blood - Ankeny
Address:
City:
Ankeny
Zip:
50023
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-282-2921
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Iowa Methodist Medical Center
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-6727
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Des Moines
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
University of Iowa/Holden Comprehensive Cancer Center
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-237-1225
Investigator:
Last name:
David P. Bender
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Melissa L. Javellana
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Indian Creek Campus
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Melissa L. Javellana
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Westwood Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Melissa L. Javellana
Email:
Principal Investigator
Facility:
Name:
Maine Medical Center- Scarborough Campus
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
207-396-8090
Email:
wrighd@mmc.org
Investigator:
Last name:
Leslie S. Bradford
Email:
Principal Investigator
Facility:
Name:
University of Michigan Comprehensive Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-865-1125
Investigator:
Last name:
Jean H. Siedel
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital
Address:
City:
Coon Rapids
Zip:
55433
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
Fairview Southdale Hospital
Address:
City:
Edina
Zip:
55435
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
Abbott-Northwestern Hospital
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
University of Minnesota/Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
612-624-2620
Investigator:
Last name:
Deanna G. Teoh
Email:
Principal Investigator
Facility:
Name:
Park Nicollet Clinic - Saint Louis Park
Address:
City:
Saint Louis Park
Zip:
55416
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
Regions Hospital
Address:
City:
Saint Paul
Zip:
55101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
United Hospital
Address:
City:
Saint Paul
Zip:
55102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
Jessica A. Thomes Pepin
Email:
Principal Investigator
Facility:
Name:
MU Health - University Hospital/Ellis Fischel Cancer Center
Address:
City:
Columbia
Zip:
65212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
573-882-7440
Investigator:
Last name:
Erin R. Tuller
Email:
Principal Investigator
Facility:
Name:
MU Health Care Goldschmidt Cancer Center
Address:
City:
Jefferson City
Zip:
65109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
573-632-4851
Email:
amy.franken@health.missouri.edu
Investigator:
Last name:
Erin R. Tuller
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center - North
Address:
City:
Kansas City
Zip:
64154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Melissa L. Javellana
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital Saint Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-251-7066
Investigator:
Last name:
Jay W. Carlson
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
505-925-0348
Email:
HSC-ClinicalTrialInfo@salud.unm.edu
Investigator:
Last name:
Carolyn Y. Muller
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Nicole S. Nevadunsky
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Weiler Hospital
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Nicole S. Nevadunsky
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center - Moses Campus
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Nicole S. Nevadunsky
Email:
Principal Investigator
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-275-5830
Investigator:
Last name:
Richard G. Moore
Email:
Principal Investigator
Facility:
Name:
State University of New York Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
315-464-5476
Investigator:
Last name:
Mary J. Cunningham
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-668-0683
Email:
cancerclinicaltrials@med.unc.edu
Investigator:
Last name:
Olivia D. Lara
Email:
Principal Investigator
Facility:
Name:
Carolinas Medical Center/Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-9376
Investigator:
Last name:
Erin K. Crane
Email:
Principal Investigator
Facility:
Name:
Atrium Health Cabarrus/LCI-Concord
Address:
City:
Concord
Zip:
28025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-9376
Investigator:
Last name:
Erin K. Crane
Email:
Principal Investigator
Facility:
Name:
UHHS-Chagrin Highlands Medical Center
Address:
City:
Beachwood
Zip:
44122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Amy Armstrong
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital South
Address:
City:
Centerville
Zip:
45459
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Michael S. Guy
Email:
Principal Investigator
Facility:
Name:
Geauga Hospital
Address:
City:
Chardon
Zip:
44024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Amy Armstrong
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Amy Armstrong
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
866-223-8100
Email:
TaussigResearch@ccf.org
Investigator:
Last name:
Peter G. Rose
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-293-5066
Email:
Jamesline@osumc.edu
Investigator:
Last name:
David M. O'Malley
Email:
Principal Investigator
Facility:
Name:
UH Seidman Cancer Center at Lake Health Mentor Campus
Address:
City:
Mentor
Zip:
44060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Amy Armstrong
Email:
Principal Investigator
Facility:
Name:
UH Seidman Cancer Center at Saint John Medical Center
Address:
City:
Westlake
Zip:
44145
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Amy Armstrong
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Debra L. Richardson
Email:
Principal Investigator
Facility:
Name:
Oklahoma Cancer Specialists and Research Institute-Tulsa
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Suspended
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Jefferson Hospital
Address:
City:
Jefferson Hills
Zip:
15025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-359-3043
Email:
ddefazio@wpahs.org
Investigator:
Last name:
Sarah M. Crafton
Email:
Principal Investigator
Facility:
Name:
Forbes Hospital
Address:
City:
Monroeville
Zip:
15146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-858-7746
Investigator:
Last name:
Sarah M. Crafton
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
215-600-9151
Email:
ONCTrialNow@jefferson.edu
Investigator:
Last name:
Ida Micaily
Email:
Principal Investigator
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-284-2000
Investigator:
Last name:
Sarah M. Crafton
Email:
Principal Investigator
Facility:
Name:
West Penn Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-578-5000
Investigator:
Last name:
Sarah M. Crafton
Email:
Principal Investigator
Facility:
Name:
Wexford Health and Wellness Pavilion
Address:
City:
Wexford
Zip:
15090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
Dawnmarie.DeFazio@ahn.org
Investigator:
Last name:
Sarah M. Crafton
Email:
Principal Investigator
Facility:
Name:
Asplundh Cancer Pavilion
Address:
City:
Willow Grove
Zip:
19090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
215-600-9151
Email:
ONCTrialNow@jefferson.edu
Investigator:
Last name:
Ida Micaily
Email:
Principal Investigator
Facility:
Name:
Women and Infants Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
401-274-1122
Investigator:
Last name:
Cara A. Mathews
Email:
Principal Investigator
Facility:
Name:
Parkland Memorial Hospital
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-590-5582
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Jayanthi S. Lea
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Jayanthi S. Lea
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Fort Worth
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Jayanthi S. Lea
Email:
Principal Investigator
Facility:
Name:
Lyndon Baines Johnson General Hospital
Address:
City:
Houston
Zip:
77026-1967
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
713-566-5000
Investigator:
Last name:
Michaela O. Grinsfelder
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-632-6789
Email:
askmdanderson@mdanderson.org
Investigator:
Last name:
Michaela O. Grinsfelder
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Clinical Center at Richardson/Plano
Address:
City:
Richardson
Zip:
75080
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
972-669-7044
Email:
Suzanne.cole@utsouthwestern.edu
Investigator:
Last name:
Jayanthi S. Lea
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-424-2100
Email:
cancerinfo@hci.utah.edu
Investigator:
Last name:
Shashank Sama
Email:
Principal Investigator
Facility:
Name:
VCU Massey Cancer Center at Stony Point
Address:
City:
Richmond
Zip:
23235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
ctoclinops@vcu.edu
Investigator:
Last name:
Chelsea Salyer
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CTOclinops@vcu.edu
Investigator:
Last name:
Chelsea Salyer
Email:
Principal Investigator
Facility:
Name:
Carilion Clinic Gynecological Oncology
Address:
City:
Roanoke
Zip:
24016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
540-985-8510
Investigator:
Last name:
Chelsea Salyer
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Institute-Edmonds
Address:
City:
Edmonds
Zip:
98026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
206-215-3086
Email:
PCRC-NCORP@Swedish.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Institute-Issaquah
Address:
City:
Issaquah
Zip:
98029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
206-215-3086
Email:
PCRC-NCORP@Swedish.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
Swedish Medical Center-First Hill
Address:
City:
Seattle
Zip:
98122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
206-215-3086
Email:
PCRC-NCORP@Swedish.org
Investigator:
Last name:
Dan S. Zuckerman
Email:
Principal Investigator
Facility:
Name:
West Virginia University Charleston Division
Address:
City:
Charleston
Zip:
25304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
304-388-9944
Investigator:
Last name:
Stephen H. Bush
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Address:
City:
Madison
Zip:
53718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Janelle Sobecki
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - University Hospital
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Janelle Sobecki
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-805-3666
Investigator:
Last name:
Elizabeth Hopp
Email:
Principal Investigator
Start date:
March 31, 2023
Completion date:
January 31, 2027
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538897
