Clinical Trials /

Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

NCT02749903

Description:

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.

Related Conditions:
  • Malignant Salivary Gland Neoplasm
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02749903

Trial Eligibility

Document

Title

  • Brief Title: Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
  • Official Title: A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers

Clinical Trial IDs

  • ORG STUDY ID: A091404
  • SECONDARY ID: NCI-2015-01706
  • NCT ID: NCT02749903

Conditions

  • Salivary Cancer

Interventions

DrugSynonymsArms
enzalutamideEnzalutamide

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
EnzalutamideOtherPatients 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.
  • enzalutamide

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best Overall Response Rate
Time Frame:Up to 32 weeks
Safety Issue:
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.

Secondary Outcome Measures

Measure:Progression-free Survival
Time Frame:Up to 32 months post study enrollment
Safety Issue:
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: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
Safety Issue:
Description:The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Alliance for Clinical Trials in Oncology

Last Updated

January 13, 2021