Protocol 10553, "A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer,"

Primary Objective

To evaluate the best overall response rate (BOR) of recurrent/metastatic androgen receptor positive (AR+) salivary gland cancer (SGC) patients within one year of darolutamide and androgen deprivation therapy (ADT

Is This Study For You?

Let's Get Started!

Description

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

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Daniel Bowles

Daniel Bowles

Study ID

Protocol Number: 23-0845

More information available at ClinicalTrials.gov: NCT05669664

Categories

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers