Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 8, 2024

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Adult Ovarian Granulosa Cell Tumor
Interventions
PROCEDURE

Biospecimen Collection

Undergo archived tissue and blood sample collection

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

DRUG

Darolutamide

Given PO

DRUG

Exemestane

Given PO

DRUG

Leuprolide Acetate

Given IM

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Trial Locations (66)

19713

Helen F Graham Cancer Center, Newark

Medical Oncology Hematology Consultants PA, Newark

25304

West Virginia University Charleston Division, Charleston

28025

Atrium Health Cabarrus/LCI-Concord, Concord

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

43560

ProMedica Flower Hospital, Sylvania

44195

Cleveland Clinic Foundation, Cleveland

45459

Miami Valley Hospital South, Centerville

46260

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48114

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

48118

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

48197

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48503

Cancer Hematology Centers - Flint, Flint

Genesee Hematology Oncology PC, Flint

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49009

Beacon Kalamazoo Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49085

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

49444

Trinity Health Muskegon Hospital, Muskegon

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

49677

Corewell Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

Medical College of Wisconsin, Milwaukee

54911

ThedaCare Regional Cancer Center, Appleton

59101

Billings Clinic Cancer Center, Billings

59405

Benefis Sletten Cancer Institute, Great Falls

59711

Community Hospital of Anaconda, Anaconda

59715

Bozeman Health Deaconess Hospital, Bozeman

59804

Community Medical Center, Missoula

60030

Northwestern Medicine Grayslake Outpatient Center, Grayslake

60045

Northwestern Medicine Lake Forest Hospital, Lake Forest

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60462

Northwestern Medicine Orland Park, Orland Park

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

61801

Carle Cancer Center, Urbana

61832

Carle at The Riverfront, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62401

Carle Physician Group-Effingham, Effingham

63141

Mercy Hospital Saint Louis, St Louis

68198

University of Nebraska Medical Center, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

83605

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83814

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

90048

Cedars Sinai Medical Center, Los Angeles

97062

Legacy Meridian Park Hospital, Tualatin

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97914

Saint Alphonsus Cancer Care Center-Ontario, Ontario

98686

Legacy Salmon Creek Hospital, Vancouver

04074

MaineHealth Maine Medical Center- Scarborough, Scarborough

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NRG Oncology

OTHER

lead

National Cancer Institute (NCI)

NIH