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Androgen Receptor Inhibitor

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

Phase 2

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival (OS)

+1 more

Other study objectives

Biomarkers predictive of response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Darolutamide

2018

Completed Phase 2

~100

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180