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NCT06169124 · ClinicalTrials.gov registry record · Phase 2
Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors
A Phase 2 study of Adult Ovarian Granulosa Cell Tumor, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT06169124 is a Phase 2 study of Adult Ovarian Granulosa Cell Tumor that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT06169124, a Phase 2 study of Adult Ovarian Granulosa Cell Tumor, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Darolutamide
- DRUG Exemestane
- PROCEDURE Chest Radiography
Study Locations (20)
Illinois
- Northwestern University - Chicago
- Carle at The Riverfront - Danville
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb
- Carle Physician Group-Effingham - Effingham
- Northwestern Medicine Cancer Center Delnor - Geneva
- Northwestern Medicine Grayslake Outpatient Center - Grayslake
- Northwestern Medicine Lake Forest Hospital - Lake Forest
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Northwestern Medicine Orland Park - Orland Park
- Carle Cancer Center - Urbana
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
California
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06169124
The ClinicalTrials.gov registry entry for NCT06169124 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adult Ovarian Granulosa Cell Tumor appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06169124 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Illinois, Idaho, Delaware.
Frequently Asked Questions
What is clinical trial NCT06169124 about?
NCT06169124 is a clinical study titled "Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors". 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 inhibi...
What is the current status of trial NCT06169124?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2024-02-08. Estimated completion is 2027-05-31.
What conditions does trial NCT06169124 study?
This clinical trial studies the following conditions: Adult Ovarian Granulosa Cell Tumor.
What interventions are being tested in trial NCT06169124?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Darolutamide (DRUG), Exemestane (DRUG), Chest Radiography (PROCEDURE).
Who is sponsoring clinical trial NCT06169124?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06169124 being conducted?
This trial has 20 study locations across California, Delaware, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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