Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

Phase 2

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Enzalutamide	enzalutamide	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.

Primary Outcome Measures

Name	Time	Method
Best Overall Response Rate	Up to 32 weeks	The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0	30 days post-treatment, up to 32 months	The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
Progression-free Survival	Up to 32 months post study enrollment	Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

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Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States