18 Years and up
Accepting Healthy Volunteers?
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
- 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.