Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT02749903
Brief Summary:
This study will test any good and bad effects of the study drug called enzalutamide. Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least 30% compared to its present size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary gland cancer, but it has already been FDA-approved to treat other cancers.
Detailed Description:
This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology.
The primary and secondary objectives of the study:
Primary objective
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
Secondary objectives
1. To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
2. To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
3. To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
Study:
NCT02749903
Study Brief:
Protocol Section:
NCT02749903