Study on Darolutamide, Leuprolide Acetate, and Exemestane for Treating Recurrent Ovarian Granulosa Cell Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06169124

Provider View

This clinical trial is testing a combination of three drugs—darolutamide, leuprolide acetate, and exemestane—to see if they can effectively treat ovarian granulosa cell tumors that have returned after previous treatment.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—darolutamide, leuprolide acetate, and exemestane—works in treating ovarian granulosa cell tumors that have come back after initial improvement. Darolutamide blocks male hormones that can help tumor cells grow. Leuprolide acetate reduces certain hormones in the body, and exemestane lowers estrogen levels, which can slow down or stop tumor growth. The goal is to see if this combination can shrink or stabilize the tumors or prevent them from returning.

Description

The main goal of this study is to find out how well the combination of darolutamide, leuprolide acetate, and exemestane works in shrinking or controlling ovarian granulosa cell tumors that have come back. Researchers will also look at how long the treatment works, how long patients live without the cancer getting worse, and overall survival rates. They will also monitor any side effects from the treatment.

Participants will take exemestane by mouth once a day and darolutamide twice a day, starting a week or two before the first treatment cycle. Leuprolide acetate will be given as an injection once every 28 days. The treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable. Throughout the study, participants will have regular scans and blood tests to monitor their health and the cancer's response to treatment. Tissue samples will be collected during the screening process.

After completing the study treatment, participants will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Must be in good health to complete the study and follow-up.
  • If HIV positive, must be on effective treatment with undetectable viral load.
  • If hepatitis B positive, must have undetectable viral load on treatment.
  • If hepatitis C positive, must be treated and cured or have undetectable viral load on treatment.
  • Can have other cancers if they do not interfere with this study.
  • Must use effective birth control during and for one month after treatment.
  • Must provide a tissue sample for the study.
  • Must have a confirmed diagnosis of recurrent ovarian granulosa cell tumor.
  • Must have measurable disease as defined by specific criteria.
  • Must have had at least one previous treatment regimen.
  • Must have progressed on a previous aromatase inhibitor treatment.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating ability to carry out daily activities.
  • Must not be pregnant or nursing.
  • Must meet specific blood count and organ function criteria.
  • Must not have active infections requiring IV antibiotics.
  • Must not have certain abdominal or gastrointestinal conditions.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Previous treatment with androgen receptor inhibitors.
  • Known allergy to the study drugs or their ingredients.

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