Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Inclusion Criteria

• •Darolutamide monotherapy group:
• •1. Signed, written informed consent.
• •2. Patients older than 20 years.
• •3. Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
• •4. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
• •5. Presence of measurable or evaluable disease according to RECIST v1.1
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• •7. Adequate organ or bone marrow function
• •8. Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.
• •Darolutamide and Goserelin combination therapy group:
• •1. Signed, written informed consent.
• •2. Patients older than 20 years.
• •3. Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
• •4. Histologically confirmed as salivary gland carcinoma at the medical institution.
• •5. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
• •6. Presence of measurable or evaluable disease according to RECIST v1.1
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• •8. Adequate organ or bone marrow function
• •9. Patients who agree to practice effective barrier contraception refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of the study drug.