Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY) (NCT05694819) | Clinical Trial Compass
CompletedPhase 2
Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
Japan57 participantsStarted 2020-04-17
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Signed, written informed consent.
✓. Patients older than 20 years.
✓. Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
✓. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
✓. Presence of measurable or evaluable disease according to RECIST v1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
✓. Adequate organ or bone marrow function
✓. 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.
Exclusion criteria
✕. Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
✕. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
✕. Metastases in the brain/central nervous system (CNS).
✕. Patients who are pregnant or breastfeeding.
✕
What they're measuring
1
Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators
Timeframe: Up to 13 month
2
Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee