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ACTIVE NOT RECRUITING Phase 2

Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers

NCT05669664 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 21 participants
Start Date 2023-07-20
Est. Completion 2027-04-11
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05669664

The ClinicalTrials.gov registry entry for NCT05669664 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 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 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05669664 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, New York, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05669664?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial