NCT02749903 · REGISTRY CONDITION SEARCH

Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-10-07

This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Proteins called androgen receptors bind to androgens (hormones) and may cause tumor cells to grow. Enzalutamide may stop the growth of tumor cells by binding to and blocking androgen receptor proteins.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Best Overall Response Rate

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: enzalutamide
label
Enzalutamide
type
OTHER

interventions

arm Group Labels
Enzalutamide
description
oral
name
enzalutamide
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 46
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Best Overall Response Rate
time Frame
Up to 32 weeks

secondary Outcomes

description
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.
measure
Progression-free Survival
time Frame
Up to 32 months post study enrollment
description
The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
measure
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
time Frame
30 days post-treatment, up to 32 months

Full study description

brief Summary: This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Proteins called androgen receptors bind to androgens (hormones) and may cause tumor cells to grow. Enzalutamide may stop the growth of tumor cells by binding to and blocking androgen receptor proteins.
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.

Source references

references

citation
Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor-Positive Salivary Gland Cancers (Alliance A091404). J Clin Oncol. 2022 Dec 20;40(36):4240-4249. doi: 10.1200/JCO.22.00229. Epub 2022 Jul 22.
pmid
35867947
type
DERIVED

Source notices and limitations

Discovery and provenance

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offset unit
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query cond
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query disease state id
ds-salivary-gland-cancer
source file
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Salivary+Gland+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice