Active Not Recruiting
PHASE2
INTERVENTIONAL
NCT05694819
Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Darolutamide
Type:
DRUG
Description:
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.
Name:
Goserelin
Type:
DRUG
Description:
Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.
Primary Outcomes
Measure:
Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators
TimeFrame:
Up to 13 month
Description:
The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators
Measure:
Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee
TimeFrame:
Up to 13 month
Description:
The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee
Trial Information
NCT ID
NCT05694819
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
National Cancer Center Hospital East
Last Updated
December 15, 2025