Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

You may be eligible if

• 1. Documentation of Disease - Histologic Documentation: Histologically proven diagnosis of salivary cancer by central pathology review. Receptor status: AR expression detected by immunohistochemistry by central review.
• 2. Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
• 3. Prior Treatment
• * Any number of prior lines of therapy
• * No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration
• * No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
• 4. Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. A female of childbearing potent is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months). For women of childbearing potential only, a negative pregnancy test done ≤ 5 days prior to registration is required.
• 5. Age ≥ 18 years
• 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• 7. No History of the following:
• * prior brain metastases
• * leptomeningeal disease
• * seizures
• * class 3 or 4 congestive heart failure
• * uncontrolled hypertension (systolic BP \> 170 mmHg or diastolic BP \> 105 mmHg)
• * major surgery ≤ 4 weeks of registration
• 8. Required Initial Laboratory Values:
• * Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
• * Platelet Count ≥ 100,000/mm3
• * Creatinine ≤ 1.5 x ULN Upper Limit of Normal (ULN) OR
• * Calculated Creatinine Clearance ≥ 30 mL/min
• * Total Bilirubin ≤ 1.5 x ULN
• * AST/ALT ≤ 3.0 x ULN
• 9. Concomitant medications- Chronic concomitant treatment with strong CYP2C8 inhibitors is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration.