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

What Was Tested

The trial (phase 2) is built around Goserelin.

It had two arms (groups): Darolutamide monotherapy (experimental) and Darolutamide plus Goserelin (experimental).

Targeted patients: 24.

Targeted patients: 32.

The registry classes the interventions as drug.

Who Took Part

The registry lists 57 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 17 inclusion and 24 exclusion criteria; among the exclusions: 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).

How the Study Was Run

Design: non-randomized, sequential and open-label.

Being open-label, the Goserelin study did not mask who received what.

It started in 2020-04-17 with completion listed for 2024-08-09.

It ran at 12 sites in Japan (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators (time frame: Up to 13 month). Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee (time frame: Up to 13 month).

It also tracked 13 secondary outcomes, for example Duration of Response (DOR), Best Overall Response (BOR), Disease Control Rate (DCR), Progression-Free Survival (PFS), Overall Survival (OS) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 57 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.