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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: Active Phase 2 study of Adult Ovarian Granulosa Cell Tumor, sponsored by National Cancer Institute (NCI).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report.
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 |
What the registry record for NCT06169124 still lists
NCT06169124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06169124's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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