Darolutamide + Hormone Therapy for Granulosa Cell Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three medications—darolutamide, leuprolide acetate, and exemestane—to evaluate their effectiveness in treating ovarian granulosa cell tumors that have recurred after earlier improvement. Darolutamide, a hormone therapy, blocks hormones that can promote tumor growth. Leuprolide acetate and exemestane lower certain hormone levels in the body, potentially slowing or stopping tumor growth. The trial seeks participants with ovarian granulosa cell tumors that have returned after prior treatment and have progressed despite previous aromatase inhibitor use. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments in this trial have been safe in past studies. Darolutamide, which blocks certain hormones, has been well tolerated by patients with prostate cancer. It helps control the disease for a long time and is safe for extended use.
Exemestane, which reduces estrogen levels, is generally safer and more effective than similar treatments. It has been used successfully in various situations.
Leuprolide acetate also has a good safety record. Specifically, in studies, it helped 66% of patients with recurrent granulosa cell tumors, a type of ovarian tumor. These results support its safe use for these tumors.
Overall, these treatments have been used safely in other conditions and could be well-tolerated in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment combination because it brings a fresh approach to tackling granulosa cell tumors. While standard treatments often focus on surgery and traditional chemotherapy, this combination uses darolutamide, exemestane, and leuprolide acetate, which together offer a novel hormonal angle. Darolutamide is particularly intriguing as it targets androgen receptors, which is a different mechanism from typical cancer treatments. This combination aims to disrupt the tumor's growth signals more effectively and could potentially offer a new lifeline for patients who haven't responded well to current options.
What evidence suggests that this combination treatment could be effective for recurrent ovarian granulosa cell tumors?
This trial will evaluate the combination of darolutamide, leuprolide acetate, and exemestane for managing ovarian granulosa cell tumors. Research suggests that darolutamide blocks male hormones, stopping tumor growth. Exemestane lowers estrogen levels, which also helps slow or stop tumor growth. One study showed that leuprolide acetate controlled these tumors in 66% of cases. Together, these treatments might shrink or stabilize tumors or prevent their recurrence.12467
Who Is on the Research Team?
Elizabeth Hopp
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive exemestane orally once daily and darolutamide orally twice daily starting on days -14 to -7 prior to cycle 1, day 1, and then on days 1-28 of each cycle. Leuprolide acetate is administered intramuscularly on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 2 years and then every 6 months for 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Darolutamide
- Exemestane
- Leuprolide Acetate
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Darolutamide is already approved in United States, European Union, Canada for the following indications:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator
Citations
NCT06169124 | Study to Test the Drug Darolutamide ...
This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell ...
Study to Test the Drug Darolutamide along with ...
This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell ...
NRG-GY033: Recurrent granulosa cell tumors
There is evidence that darolutamide, leuprolide acetate, and exemestane can shrink or stabilize your type of cancer. It is not possible to know now if the study ...
Safety and Antitumour Activity of ODM-201 (BAY-1841788) ...
Prolonged treatment with high doses of ODM-201 was well tolerated and provided long-lasting disease control in patients with mCRPC. ODM-201 represents a ...
5.
ema.europa.eu
ema.europa.eu/en/documents/assessment-report/nubeqa-epar-public-assessment-report_en.pdfAssessment report - darolutamide - EMA - European Union
It included fibroadenoma of mammary glands and benign thymoma of thymus in males, benign granulosa cell tumours of ovaries in females, and ...
New Data for NUBEQA® Build on Safety and Efficacy ...
The subgroup analysis showed that, in the low-volume (LV) subgroup, NUBEQA plus ADT reduced the risk of radiological progression or death by 70% ...
FDA approves darolutamide for metastatic castration ...
Treatment with darolutamide resulted in a statistically significant improvement in rPFS compared to placebo. Median rPFS was not reached in the ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.