Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

27mo left

Started Sep 2016

Longer than P75 for phase_2

Geographic Reach

1 country

287 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.8 years study duration

Study Progress82%

Sep 2016Jul 2028

First Submitted

Initial submission to the registry

April 21, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed

5 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed

11 months until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed

8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2028

Expected

Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

April 21, 2016

Results QC Date

December 11, 2019

Last Update Submit

January 23, 2026

Conditions

Salivary Cancer

Outcome Measures

Primary Outcomes (1)

Best Overall Response Rate
The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Up to 32 weeks

Secondary Outcomes (2)

Progression-free Survival
Up to 32 months post study enrollment
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
30 days post-treatment, up to 32 months

Study Arms (1)

Enzalutamide

OTHER

Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.

Drug: enzalutamide

Interventions

enzalutamideDRUG

oral

Enzalutamide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator
Astellas Pharma US, Inc.collaborator

Study Sites (287)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC