Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT02749903
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02749903
Study Brief:
Protocol Section:
NCT02749903