NCT05694819

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

Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.

Conditions

• Salivary Gland Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide	Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.
DRUG	Goserelin	Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.

Timeline

• Start date: 2020-04-17
• Primary completion: 2024-08-09
• Completion: 2026-03-23
• First posted: 2023-01-23
• Last updated: 2026-04-08

Locations

12 sites across 1 country: Japan