Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers|
- best overall response rate [ Time Frame: Up to 32 weeks ]
- progression-free survival [ Time Frame: Up to 3 years post study enrollment ]
- adverse events (The maximum grade for each type of adverse event will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]
- adverse events (The frequency and percentage of grade 3+ adverse events will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]
|Study Start Date:||June 2016|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
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:
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
- To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02749903
|Contact: Alan Ho, MD, PhD||646-888-4235|
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|Study Chair:||Alan Ho, MD||Memorial Sloan Kettering Cancer Center|