Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors
Public ClinicalTrials.gov record NCT06169124. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination With Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell tumors that have come back after a period of improvement (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone agonists. It works by decreasing the amount of certain hormones in the body. Exemestane is in a class of medications called aromatase inhibitors which has anti-estrogen and anticancer activities. Exemestane binds to and inhibits the enzyme aromatase, thereby blocking the conversion of androgens to estrogens. This lowers estrogen levels in the blood circulation causing the tumor cells to grow more slowly or stop growing completely. The combination of darolutamide, leuprolide acetate, and exemestane may be an effective approach to shrinking or stabilizing recurrent ovarian granulosa cell tumors or preventing them from coming back.
Study identification
- NCT ID
- NCT06169124
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Chest Radiography Procedure
- Computed Tomography Procedure
- Darolutamide Drug
- Exemestane Drug
- Leuprolide Acetate Drug
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 8, 2024 (Actual)
- Primary completion
- Feb 10, 2026 (Actual)
- Completion
- Jul 24, 2027 (Estimated)
- Last update posted
- Jul 28, 2026
2024 – 2027
United States locations
- U.S. sites
- 66
- U.S. states
- 18
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | — |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | — |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | — |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | — |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | — |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | — |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| Northwestern Medicine Grayslake Outpatient Center | Grayslake | Illinois | 60030 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| MaineHealth Maine Medical Center- Scarborough | Scarborough | Maine | 04074 | — |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | — |
| Cancer Hematology Centers - Flint | Flint | Michigan | 48503 | — |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | — |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Beacon Kalamazoo Cancer Center | Kalamazoo | Michigan | 49009 | — |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | — |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | — |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | — |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Community Medical Center | Missoula | Montana | 59804 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Saint Alphonsus Cancer Care Center-Ontario | Ontario | Oregon | 97914 | — |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | — |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | — |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06169124, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06169124 live on ClinicalTrials.gov.