Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Condition: Salivary Cancer
Intervention: enzalutamide
Intervention description: oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.