Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

What Was Tested

This registered phase 2 trial tested Leuprolide.

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

It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells.

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

The registry classes the interventions as drug and procedure.

More on the Plan

To determine the objective response rate of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

To determine duration of response of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

To determine progression-free survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

To determine overall survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

Who Took Part

The registry lists 17 actual participants took part.

It was open to women only 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: Physicians should consider the following when evaluating if the patient is appropriate for this protocol:. Patients must have adequate health that permits completion of the study requirements and required follow up. For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection:. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Submission of tissue is required. Investigators should check with their pathology department regarding release of tissue before approaching patients about participation in the trial.

The full record lists 26 inclusion and 2 exclusion criteria; among the exclusions: prior treatment with ar inhibitors; known hypersensitivity to the study drugs or their ingredients.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2024-02-08 with completion listed for 2026-02-10.

It ran at 66 sites in United States (66).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective response rate (time frame: Within 9 months of initiating study treatment).

It also tracked 4 secondary outcomes, for example Duration of response, Progression-free survival (PFS), Overall survival (OS) and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 17 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.