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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
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE April 21, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date May 29, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
best overall response rate [ Time Frame: Up to 32 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02749903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
  • progression-free survival [ Time Frame: Up to 3 years post study enrollment ]
  • adverse events (The maximum grade for each type of adverse event will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]
  • adverse events (The frequency and percentage of grade 3+ adverse events will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Official Title  ICMJE A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Salivary Cancer
Intervention  ICMJE Drug: enzalutamide
oral
Study Arms  ICMJE 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.
Intervention: Drug: enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2018)
46
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2016)
45
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02749903
Other Study ID Numbers  ICMJE A091404
NCI-2015-01706 ( Registry Identifier: NCI Clinical Trial Reporting Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Astellas Pharma US, Inc.
Investigators  ICMJE
Study Chair: Alan Ho, MD Memorial Sloan Kettering Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP