Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
Public ClinicalTrials.gov record NCT05669664. 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 2 Study of Darolutamide in Combination With Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) or that has come back after a period of responding to prior therapy (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 cancer cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body. Giving darolutamide in combination with leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow or shrink them.
Study identification
- NCT ID
- NCT05669664
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Darolutamide Drug
- Leuprolide Acetate Drug
- Magnetic Resonance Imaging Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Jul 20, 2023 (Actual)
- Primary completion
- Nov 30, 2026 (Estimated)
- Completion
- Nov 30, 2026 (Estimated)
- Last update posted
- Jul 31, 2026
2023 – 2026
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | — |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | — |
| UChicago Medicine Northwest Indiana | Crown Point | Indiana | 46307 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
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 NCT05669664, 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 31, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05669664 live on ClinicalTrials.gov.