Testing the Anti-Cancer Drug Darolutamide in Patients with Testosterone-Driven Salivary Gland Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05669664

Provider View

This clinical trial is exploring how well the drug darolutamide, combined with leuprolide acetate, works in treating salivary gland cancer that is driven by male hormones and has spread, cannot be removed by surgery, or has returned after treatment. The study aims to see if this combination can stop or shrink the cancer.

Patient Parameters

Program Overview

This study is testing a treatment for salivary gland cancer that relies on male hormones to grow. The treatment uses two drugs: darolutamide, which blocks male hormones, and leuprolide acetate, which reduces certain hormones in the body. The goal is to see if this combination can stop the cancer from growing or make it smaller in patients whose cancer has spread, cannot be surgically removed, or has come back after previous treatment.

Description

The main goal of this study is to see how well the combination of darolutamide and hormone therapy works in shrinking or stopping the growth of salivary gland cancer that has spread or returned. Researchers will also look at how long patients live without the cancer getting worse and their overall survival. They will monitor any side effects of the treatment.

Patients will take darolutamide pills twice a day and receive leuprolide acetate injections every 4 or 12 weeks. This cycle repeats every 28 days unless the cancer progresses or side effects become too severe. Throughout the trial, patients will have biopsies, blood tests, and scans to check the cancer's response.

After finishing the treatment, patients will have follow-up visits every 3-6 months for up to 2 years or until they pass away, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed salivary gland cancer that has spread, cannot be removed by surgery, or has returned, and shows androgen receptor activity.
  • Have measurable cancer that can be tracked.
  • Have not had previous treatments targeting androgen receptors, except in specific early treatment settings with a gap of more than 6 months since completion.
  • Be 18 years or older.
  • Be in good general health with a performance status score of 2 or less.
  • Have adequate blood cell counts and organ function based on specific tests.
  • HIV-positive patients can participate if their viral load is undetectable with treatment.
  • Patients with controlled hepatitis B or cured hepatitis C can participate.
  • Patients with treated brain metastases can participate.
  • Patients with other cancers that do not interfere with this study can participate.
  • Women and men must agree to use effective birth control during the study and for a period after treatment.
  • Be able to understand and sign a consent form.
  • Have tumors that can be safely biopsied.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss and mild nerve damage.
  • Have had a vascular or blood flow event within 6 months before joining the study.
  • Are taking other experimental drugs.
  • Have allergies to similar drugs as darolutamide or leuprolide acetate.
  • Are taking certain medications that interact with the study drugs.
  • Have uncontrolled illnesses.
  • Are pregnant or breastfeeding, due to potential risks to the baby.
  • Have moderate liver problems.

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