NCT06169124|Active Not RecruitingPhase 2FDA Drug

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

A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination With Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2023-06524NRG-GY033U10CA180868

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2023

StartedFeb 2024

CompletionMay 2027

Brief Summary

This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell tumors that have come back after a period of improvement (recurrent). 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. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone agonists. It works by decreasing the amount of certain hormones in the body. Exemestane is in a class of medications called aromatase inhibitors which has anti-estrogen and anticancer activities. Exemestane binds to and inhibits the enzyme aromatase, thereby blocking the conversion of androgens to estrogens. This lowers estrogen levels in the blood circulation causing the tumor cells to grow more slowly or stop growing completely. The combination of darolutamide, leuprolide acetate, and exemestane may be an effective approach to shrinking or stabilizing recurrent ovarian granulosa cell tumors or preventing them from coming back.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

13mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach

1 country

66 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.3 years study duration

Study Progress68%

Feb 2024May 2027

First Submitted

Initial submission to the registry

December 7, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

December 7, 2023

Last Update Submit

May 1, 2026

Conditions

Adult Ovarian Granulosa Cell Tumor

Outcome Measures

Primary Outcomes (1)

Objective response rate
Defined as a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report.
Within 9 months of initiating study treatment

Secondary Outcomes (4)

Duration of response
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Progression-free survival (PFS)
From study entry to time of progression or death, whichever occurs first, or date of last contact with known progression free status if neither progression nor death has occurred, assessed up to 5 years
Overall survival (OS)
From study entry to time of death or the date of last contact, assessed up to 5 years
Incidence of adverse events
Up to 5 years

Other Outcomes (1)

Biomarkers predictive of response
Up to 5 years

Study Arms (1)

Treatment (exemestane, darolutamide, leuprolide acetate)

EXPERIMENTAL

Patients receive exemestane PO QD and darolutamide PO BID starting on days -14 to -7 prior to C1D1 and then on days 1-28 of each cycle. Patients receive leuprolide acetate IM on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo chest CT or chest x-ray and CT, MRI, or PET/CT as well as blood sample collection throughout the study. Patients undergo collection of archived tissue during screening.

Procedure: Biospecimen CollectionProcedure: Chest RadiographyProcedure: Computed TomographyDrug: DarolutamideDrug: ExemestaneDrug: Leuprolide AcetateProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography