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Androgen Receptor Inhibitor

Treatment (exemestane, darolutamide, leuprolide acetate) for Granulosa Cell Tumor

Phase 2

Recruiting

Led By Elizabeth Hopp

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests a combination of drugs to treat recurrent ovarian granulosa cell tumors by blocking hormones that cause tumor growth.

Who is the study for?

This trial is for adults with recurrent ovarian granulosa cell tumors who've had at least one prior treatment and have progressed on an aromatase inhibitor. They must be in good health, not pregnant or nursing, and willing to use contraception. People with certain heart conditions, infections, or other cancers that could affect the study can't join.Check my eligibility

What is being tested?

The trial tests a combination of darolutamide (blocks male hormones), leuprolide acetate (lowers certain hormones), and exemestane (stops estrogen production) to see if they can slow down or stop tumor growth in patients whose ovarian cancer has returned.See study design

What are the potential side effects?

Potential side effects may include hormonal changes leading to hot flashes or mood swings, fatigue, bone density loss, joint pain from lowered estrogen levels, liver function changes, and possible heart-related issues due to hormone alterations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate

Secondary outcome measures

Duration of response

Incidence of adverse events

Overall survival (OS)

+1 more

Other outcome measures

Biomarkers predictive of response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (exemestane, darolutamide, leuprolide acetate)Experimental Treatment8 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Exemestane

2003

Completed Phase 4

~7880

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Darolutamide

2018

Completed Phase 2

~100

Chest Radiography

2018

N/A

~560

Leuprolide Acetate

2002

Completed Phase 3

~1890

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,670 Previous Clinical Trials

40,926,699 Total Patients Enrolled

3 Trials studying Granulosa Cell Tumor

130 Patients Enrolled for Granulosa Cell Tumor

NRG OncologyOTHER

231 Previous Clinical Trials

100,815 Total Patients Enrolled

1 Trials studying Granulosa Cell Tumor

36 Patients Enrolled for Granulosa Cell Tumor

Elizabeth HoppPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being added to this investigation currently?

"Per data from clinicaltrials.gov, this trial is not actively recruiting participants at the moment. The study was initiated on December 15th 2023 and has been revised as recently as December 7th 2023. Nevertheless, there are 3 other medical trials looking for volunteers currently."

Answered by AI

To what extent could Treatment (exemestane, darolutamide, leuprolide acetate) be detrimental to individuals?

"Based on the evidence available, our team at Power assigned a score of 2 to Treatment (exemestane, darolutamide, leuprolide acetate) in terms of safety. This is because it has only undergone Phase 2 trials and there is no data regarding its efficacy as yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169124.

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