NCT02749903

Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Salivary Cancer

Interventions

Type	Name	Description
DRUG	enzalutamide	oral

Timeline

• Start date: 2016-09-14
• Primary completion: 2019-02-21
• Completion: 2028-07-05
• First posted: 2016-04-25
• Last updated: 2026-02-11
• Results posted: 2020-01-13

Locations

287 sites across 1 country: United States