Skip to content

Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749903
Enrollment
46
Registered
2016-04-25
Start date
2016-09-14
Completion date
2028-07-05
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Salivary Cancer

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.

Detailed description

This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology. The primary and secondary objectives of the study: Primary objective To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers Secondary objectives 1. To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide 2. To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide 3. To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer Patients are followed up to 3 years after study enrollment.

Interventions

DRUGenzalutamide

oral

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Astellas Pharma US, Inc.
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Best Overall Response RateUp to 32 weeksThe 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.

Secondary

MeasureTime frameDescription
Progression-free SurvivalUp to 32 months post study enrollmentProgression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.030 days post-treatment, up to 32 monthsThe number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.

Countries

United States

Contacts

STUDY_CHAIRAlan Ho, MD

Memorial Sloan Kettering Cancer Center

Participant flow

Participants by arm

ArmCount
Enzalutamide
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.
46
Total46

Baseline characteristics

CharacteristicEnzalutamide
Age, Continuous67.1 years
STANDARD_DEVIATION 10.8
ECOG Performance Status
0
25 Participants
ECOG Performance Status
1
21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
39 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
40 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
27 / 46
other
Total, other adverse events
44 / 46
serious
Total, serious adverse events
15 / 46

Outcome results

Primary

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.

Time frame: Up to 32 weeks

ArmMeasureValue (NUMBER)
EnzalutamideBest Overall Response Rate4.3 percentage of patients
Secondary

Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0

The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.

Time frame: 30 days post-treatment, up to 32 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EnzalutamideNumber of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.022 Participants
Secondary

Progression-free Survival

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: Up to 32 months post study enrollment

ArmMeasureValue (MEDIAN)
EnzalutamideProgression-free Survival5.6 months

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026