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
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
Locations
University of Colorado Hospital
Principal Investigator
Daniel Bowles
Study ID
Protocol Number: 23-0845
More information available at ClinicalTrials.gov: NCT05669664
Categories
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