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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 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.

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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.

Conditions Studied

Recurrent Salivary Gland Carcinoma Metastatic Salivary Gland Carcinoma Unresectable Salivary Gland Carcinoma Locally Advanced Salivary Gland Carcinoma

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)

3,257 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, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 5 other Recurrent Salivary Gland Carcinoma trials with a reported enrollment target (84% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.