Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers

What Was Tested

The trial (phase 2) is built around Leuprolide.

Darolutamide is in a class of medications called androgen receptor inhibitors.

It had 1 arm (groups): Treatment (darolutamide, leuprolide acetate) (experimental).

Patients receive darolutamide PO BID on days 1-28 of each cycle and leuprolide acetate IM every 4 or 12 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, collection of blood samples, and CT/MRI throughout the trial.

The registry classes the interventions as drug and procedure.

More on the Plan

To evaluate progression-free survival (PFS).

To evaluate overall survival (OS).

To evaluate toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

To evaluate molecular, genomic and transcriptomic biomarkers in serial research biopsies obtained before and on darolutamide and ADT.

Who Took Part

The registry lists 21 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients must have measurable disease. Patients must have not had prior AR-targeted therapy, except for AR-targeted therapy administered in the neoadjuvant and/or adjuvant setting and with disease recurrence more than 6 months since treatment completion. Absolute neutrophil count \>= 1,000/mcL. Platelets \>= 100,000/mcL. Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (exception: patients with elevated bilirubin due to Gilbert's disease would be eligible for the trial).

The full record lists 21 inclusion and 8 exclusion criteria; among the exclusions: patients with a vascular or ischemic event within 6 months of study registration; patients who are receiving any other investigational agents; history of allergic reactions attributed to compounds of similar chemical or biologic composition to darolutamide or leuprolide acetate.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-07-20 with completion listed for 2026-11-30.

It ran at 27 sites in United States (27).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Best overall response (BOR) (time frame: Within 1 year of initiating treatment).

It also tracked 3 secondary outcomes, for example Progression-free survival (PFS), Overall survival (OS) and Incidence of adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 21 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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