NRG-GY033

Clinical Trial Title 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
Trial Status Open to Enrollment
Start Date 03/12/2024
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

  • Histologically confirmed diagnosis of recurrent adult-type granulosa cell tumor.
  • Patient must have measurable disease. Measurable disease is defined in the protocol per RECIST 1.1 criteria. Measurable disease is defined as at least one lesion that can beaccurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
  • Patient must have had ≥1 treatment regimen.
  • Subject must have progressed on an aromatase inhibitor (letrozole, exemestane, anastrozole) in a prior treatment line.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors | ClinicalTrials.gov
Principal Investigator Julia Fehniger, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org