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

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Enzalutamide</span> for Patients With <span class="go-doc-concept go-doc-alteration">Androgen Receptor Positive</span> Salivary Cancers

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

    NCT ID: NCT02749903

    ORG ID: A091404

    NCI ID: NCI-2015-01706

    Trial Conditions

    Salivary Cancer

    Trial Interventions

    Drug Synonyms Arms
    enzalutamide Enzalutamide

    Trial 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

    Name Type Description Interventions
    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. 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    best overall response rate

    Secondary Outcome Measures

    progression-free survival

    adverse events (The maximum grade for each type of adverse event will be summarized using CTCAE version 4.0.)

    adverse events (The frequency and percentage of grade 3+ adverse events will be summarized using CTCAE version 4.0.)

    Trial Keywords