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Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

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ClinicalTrials.gov Identifier: NCT02749903
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Salivary Cancer Drug: enzalutamide Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
Study Start Date : June 2016
Actual Primary Completion Date : February 21, 2019
Estimated Study Completion Date : July 5, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: enzalutamide
oral


Outcome Measures
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Primary Outcome Measures :
  1. Best Overall Response Rate [ Time Frame: Up to 32 weeks ]
    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.


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Up to 32 months post study enrollment ]
    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.

  2. 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 ]
    The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749903


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Investigators
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Study Chair: Alan Ho, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Alliance for Clinical Trials in Oncology:
Study Protocol and Statistical Analysis Plan  [PDF] September 10, 2019

More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02749903    
Other Study ID Numbers: A091404
NCI-2015-01706 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: April 25, 2016    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2021
Last Verified: January 2021