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NCT05669664 · ClinicalTrials.gov registry record · Phase 2
Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
A Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 20
- Study locations
NCT05669664: Active Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05669664 is a Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 131-participant average among 5 other Recurrent Salivary Gland Carcinoma trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669664, a Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The trial will be considered positive if 8 or more complete response/partial response are observed in stage 1 and stage 2 combined.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Darolutamide
- DRUG Leuprolide Acetate
Study Locations (20)
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Colorado
- UCHealth University of Colorado Hospital - Aurora
Georgia
- Emory University Hospital Midtown - Atlanta
Indiana
- UChicago Medicine Northwest Indiana - Crown Point
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-07-20 |
| Est. Completion | 2027-04-11 |
| Phase | Phase 2 |
What the registry record for NCT05669664 still lists
NCT05669664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 131-participant average among 5 other Recurrent Salivary Gland Carcinoma trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Recurrent Salivary Gland Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05669664 names 20 study sites across 8 states, led by California, New York, Illinois.
Frequently Asked Questions
What is clinical trial NCT05669664 about?
NCT05669664 is a clinical study titled "Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers". 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 ha...
What is the current status of trial NCT05669664?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2023-07-20. Estimated completion is 2027-04-11.
What conditions does trial NCT05669664 study?
This clinical trial studies the following conditions: Recurrent Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Unresectable Salivary Gland Carcinoma, Locally Advanced Salivary Gland Carcinoma.
What interventions are being tested in trial NCT05669664?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Darolutamide (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT05669664?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05669664 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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