Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.