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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Salivary Cancer
Intervention Drug: enzalutamide
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
67.1  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
6
  13.0%
Male
40
  87.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.2%
White
39
  84.8%
More than one race
0
   0.0%
Unknown or Not Reported
4
   8.7%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
0
25
  54.3%
1
21
  45.7%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
1.Primary Outcome
Title Best Overall Response Rate
Hide 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.
Time Frame Up to 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
4.3
(0.5 to 14.8)
2.Secondary Outcome
Title Progression-free Survival
Hide 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.
Time Frame Up to 32 months post study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(3.7 to 7.5)
3.Secondary Outcome
Title Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
Hide Description The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
Time Frame 30 days post-treatment, up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
22
  47.8%
Time Frame Up to 30 days post-treatment, up to 32 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enzalutamide
Hide Arm/Group 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.
All-Cause Mortality
Enzalutamide
Affected / at Risk (%)
Total   27/46 (58.70%)    
Hide Serious Adverse Events
Enzalutamide
Affected / at Risk (%) # Events
Total   15/46 (32.61%)    
Cardiac disorders   
Heart failure  1  1/46 (2.17%)  2
Myocardial infarction  1  1/46 (2.17%)  1
Gastrointestinal disorders   
Dysphagia  1  1/46 (2.17%)  1
Small intestinal obstruction  1  1/46 (2.17%)  1
Infections and infestations   
Bone infection  1  1/46 (2.17%)  3
Infections and infestations - Oth spec  1  1/46 (2.17%)  1
Sepsis  1  1/46 (2.17%)  1
Injury, poisoning and procedural complications   
Spinal fracture  1  1/46 (2.17%)  1
Investigations   
Alkaline phosphatase increased  1  1/46 (2.17%)  1
Metabolism and nutrition disorders   
Hypoalbuminemia  1  1/46 (2.17%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/46 (2.17%)  1
Musculoskeletal, conn tissue - Oth spec  1  1/46 (2.17%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/46 (2.17%)  1
Nervous system disorders   
Dizziness  1  1/46 (2.17%)  1
Edema cerebral  1  1/46 (2.17%)  1
Headache  1  1/46 (2.17%)  1
Nervous system disorders - Oth spec  1  1/46 (2.17%)  1
Stroke  1  1/46 (2.17%)  1
Psychiatric disorders   
Insomnia  1  1/46 (2.17%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/46 (2.17%)  1
Resp, thoracic, mediastinal - Oth spec  1  1/46 (2.17%)  1
Respiratory failure  1  2/46 (4.35%)  2
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enzalutamide
Affected / at Risk (%) # Events
Total   44/46 (95.65%)    
Blood and lymphatic system disorders   
Anemia  1  11/46 (23.91%)  22
Cardiac disorders   
Atrial fibrillation  1  1/46 (2.17%)  4
Cardiac disorders - Other, specify  1  1/46 (2.17%)  12
Heart failure  1  1/46 (2.17%)  2
Ear and labyrinth disorders   
Ear pain  1  2/46 (4.35%)  5
Hearing impaired  1  1/46 (2.17%)  4
Tinnitus  1  1/46 (2.17%)  1
Eye disorders   
Blurred vision  1  1/46 (2.17%)  1
Dry eye  1  1/46 (2.17%)  3
Eye disorders - Other, specify  1  1/46 (2.17%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/46 (2.17%)  1
Constipation  1  7/46 (15.22%)  32
Dental caries  1  1/46 (2.17%)  1
Diarrhea  1  13/46 (28.26%)  36
Dry mouth  1  4/46 (8.70%)  22
Dysphagia  1  3/46 (6.52%)  22
Gastroesophageal reflux disease  1  3/46 (6.52%)  8
Gastrointestinal disorders - Oth spec  1  1/46 (2.17%)  1
Mucositis oral  1  1/46 (2.17%)  1
Nausea  1  8/46 (17.39%)  13
Oral pain  1  1/46 (2.17%)  1
Stomach pain  1  1/46 (2.17%)  3
Toothache  1  1/46 (2.17%)  3
Vomiting  1  5/46 (10.87%)  7
General disorders   
Edema limbs  1  2/46 (4.35%)  3
Facial pain  1  1/46 (2.17%)  4
Fatigue  1  40/46 (86.96%)  205
Fever  1  1/46 (2.17%)  2
Gen disord and admin site conds-Oth spec  1  3/46 (6.52%)  8
Localized edema  1  9/46 (19.57%)  22
Neck edema  1  1/46 (2.17%)  1
Non-cardiac chest pain  1  1/46 (2.17%)  3
Pain  1  6/46 (13.04%)  24
Infections and infestations   
Gum infection  1  1/46 (2.17%)  1
Injury, poisoning and procedural complications   
Fall  1  1/46 (2.17%)  1
Fracture  1  1/46 (2.17%)  2
Inj, pois and proced complic - Oth spec  1  1/46 (2.17%)  4
Investigations   
Alanine aminotransferase increased  1  3/46 (6.52%)  5
Alkaline phosphatase increased  1  5/46 (10.87%)  9
Aspartate aminotransferase increased  1  6/46 (13.04%)  14
Blood bilirubin increased  1  1/46 (2.17%)  2
Creatinine increased  1  1/46 (2.17%)  2
Investigations - Other, specify  1  1/46 (2.17%)  20
Lymphocyte count decreased  1  8/46 (17.39%)  25
Neutrophil count decreased  1  1/46 (2.17%)  1
Platelet count decreased  1  1/46 (2.17%)  2
Weight gain  1  1/46 (2.17%)  2
Weight loss  1  21/46 (45.65%)  44
White blood cell decreased  1  5/46 (10.87%)  10
Metabolism and nutrition disorders   
Anorexia  1  10/46 (21.74%)  37
Hyperglycemia  1  7/46 (15.22%)  26
Hypoalbuminemia  1  2/46 (4.35%)  5
Hypocalcemia  1  2/46 (4.35%)  3
Hypoglycemia  1  2/46 (4.35%)  4
Hyponatremia  1  4/46 (8.70%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/46 (8.70%)  6
Arthritis  1  1/46 (2.17%)  7
Back pain  1  5/46 (10.87%)  9
Flank pain  1  3/46 (6.52%)  4
Generalized muscle weakness  1  2/46 (4.35%)  5
Joint effusion  1  2/46 (4.35%)  4
Muscle weakness lower limb  1  1/46 (2.17%)  3
Musculoskeletal, conn tissue - Oth spec  1  2/46 (4.35%)  10
Myalgia  1  1/46 (2.17%)  1
Neck pain  1  4/46 (8.70%)  17
Pain in extremity  1  6/46 (13.04%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/46 (2.17%)  1
Nervous system disorders   
Dizziness  1  13/46 (28.26%)  41
Dysgeusia  1  3/46 (6.52%)  24
Dysphasia  1  1/46 (2.17%)  1
Facial nerve disorder  1  2/46 (4.35%)  7
Headache  1  3/46 (6.52%)  11
Paresthesia  1  3/46 (6.52%)  4
Peripheral sensory neuropathy  1  2/46 (4.35%)  3
Seizure  1  1/46 (2.17%)  4
Syncope  1  1/46 (2.17%)  1
Tremor  1  2/46 (4.35%)  2
Psychiatric disorders   
Anxiety  1  2/46 (4.35%)  7
Depression  1  2/46 (4.35%)  6
Hallucinations  1  1/46 (2.17%)  1
Insomnia  1  8/46 (17.39%)  30
Libido decreased  1  1/46 (2.17%)  6
Psychiatric disorders - Other, specify  1  1/46 (2.17%)  1
Renal and urinary disorders   
Renal and urinary disorders - Oth spec  1  1/46 (2.17%)  2
Urinary tract pain  1  1/46 (2.17%)  1
Reproductive system and breast disorders   
Breast pain  1  10/46 (21.74%)  72
Gynecomastia  1  8/46 (17.39%)  67
Pelvic pain  1  2/46 (4.35%)  2
Reproductive system and breast -Oth spec  1  1/46 (2.17%)  3
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/46 (2.17%)  3
Aspiration  1  1/46 (2.17%)  2
Cough  1  6/46 (13.04%)  12
Dyspnea  1  6/46 (13.04%)  13
Hoarseness  1  2/46 (4.35%)  5
Nasal congestion  1  1/46 (2.17%)  4
Pleural effusion  1  1/46 (2.17%)  4
Productive cough  1  2/46 (4.35%)  2
Wheezing  1  1/46 (2.17%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/46 (2.17%)  28
Dry skin  1  2/46 (4.35%)  9
Hyperhidrosis  1  3/46 (6.52%)  8
Pruritus  1  1/46 (2.17%)  3
Rash maculo-papular  1  1/46 (2.17%)  2
Skin and subcut tissue disord - Oth spec  1  2/46 (4.35%)  3
Skin induration  1  1/46 (2.17%)  1
Vascular disorders   
Hot flashes  1  22/46 (47.83%)  123
Hypertension  1  34/46 (73.91%)  207
Hypotension  1  1/46 (2.17%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan Ho, MD, PhD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4235
EMail: hoa@mskcc.org
Layout table for additonal information
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 Submitted: April 21, 2016
First Posted: April 25, 2016
Results First Submitted: December 11, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2021