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

UVA Tracking #
HSR230200
Principal Investigator
Varinder Kaur
Contact
Contact Phone
Official Trial Title
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
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have salivary gland cancer that has spread, cannot be removed, or has come back, and has a protein called the AR (androgen receptor). The purpose of this study is to test the effects of a combination of drugs called darolutamide and leuprolide acetate and whether or not it could shrink your cancer. Daraolutamide and leuprolide acetate have already been approved by the FDA to treat other cancers, but this drug combination is not approved by the FDA for treatment of your disease. This study consists of cycles. Each cycle lasts 28 days. If you take part in this study, you will take darolutamide as a pill twice daily. You will receive leuprolide acetate as an injection in your arm every 4 weeks or every 12 weeks, depending on what you and the study doctor decide.

You will receive study treatment until your disease progresses. After you finish study treatment, your doctor will continue to follow your condition with phone calls every 3 to 6 months for 2 years.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://www.clinicaltrials.gov/study/NCT05669664

Compensation

No Compensation