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Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors

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ClinicalTrials.gov Identifier: NCT00859937
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : April 3, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Malignant Salivary Gland Neoplasm
Recurrent Salivary Gland Carcinoma
Salivary Gland Adenoid Cystic Carcinoma
Stage IV Major Salivary Gland Cancer AJCC v7
Interventions Drug: Dasatinib
Other: Laboratory Biomarker Analysis
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 41 14
Completed 40 14
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma Total
Hide Arm/Group Description Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 40 14 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 14 participants 54 participants
56
(30 to 82)
56
(20 to 71)
56
(20 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 14 participants 54 participants
Female
22
  55.0%
4
  28.6%
26
  48.1%
Male
18
  45.0%
10
  71.4%
28
  51.9%
1.Primary Outcome
Title Response Rate
Hide Description Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 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; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description:
Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 14
Measure Type: Number
Unit of Measure: participants
Complete response 0 0
Partial response 1 0
Stable disease 20 7
Progressive disease 12 4
Other 7 3
2.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description:
Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 14
Median (90% Confidence Interval)
Unit of Measure: months
4.8
(1.9 to 5.5)
2.7
(1.8 to 5.5)
3.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description:
Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 14
Median (90% Confidence Interval)
Unit of Measure: months
14.5
(8.8 to 31.7)
4.8
(2.2 to 8.0)
4.Secondary Outcome
Title Changes in Laboratory Correlates
Hide Description Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description:
Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 5 years
Adverse Event Reporting Description All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
 
Arm/Group Title Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Hide Arm/Group Description Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   12/40 (30.00%)   8/14 (57.14%) 
Cardiac disorders     
Chest pain  0/40 (0.00%)  1/14 (7.14%) 
Eye disorders     
Loss of vision  1/40 (2.50%)  0/14 (0.00%) 
Gastrointestinal disorders     
Dysphagia  0/40 (0.00%)  1/14 (7.14%) 
Nausea  1/40 (2.50%)  0/14 (0.00%) 
General disorders     
Non-cardiac chest pain  0/40 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Infections and infestations  1/40 (2.50%)  0/14 (0.00%) 
Investigations     
Alanine aminotransferase increased  1/40 (2.50%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1/40 (2.50%)  1/14 (7.14%) 
Hyperglycemia  1/40 (2.50%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death  2/40 (5.00%)  1/14 (7.14%) 
Nervous system disorders     
Cauda equina syndrome  1/40 (2.50%)  0/14 (0.00%) 
Psychiatric disorders     
Confusion  0/40 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  3/40 (7.50%)  1/14 (7.14%) 
Hypoxia  0/40 (0.00%)  1/14 (7.14%) 
Pleural effusion  1/40 (2.50%)  0/14 (0.00%) 
Pneumonitis  1/40 (2.50%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria  1/40 (2.50%)  0/14 (0.00%) 
Vascular disorders     
Thromboembolic event  0/40 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adenoid Cystic Carcinoma Non Adenoid Cystic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   39/40 (97.50%)   13/14 (92.86%) 
Blood and lymphatic system disorders     
Anemia  20/40 (50.00%)  5/14 (35.71%) 
Lymph node pain  0/40 (0.00%)  1/14 (7.14%) 
Cardiac disorders     
Palpitations  0/40 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders     
Ear pain  2/40 (5.00%)  0/14 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  0/40 (0.00%)  1/14 (7.14%) 
Constipation  11/40 (27.50%)  1/14 (7.14%) 
Diarrhea  13/40 (32.50%)  6/14 (42.86%) 
Dry mouth  1/40 (2.50%)  1/14 (7.14%) 
Dyspepsia  2/40 (5.00%)  0/14 (0.00%) 
Dysphagia  4/40 (10.00%)  1/14 (7.14%) 
Eructation  0/40 (0.00%)  1/14 (7.14%) 
Gastroesophageal reflux disease  1/40 (2.50%)  1/14 (7.14%) 
Nausea  16/40 (40.00%)  8/14 (57.14%) 
Oral pain  3/40 (7.50%)  0/14 (0.00%) 
Rectal hemorrhage  0/40 (0.00%)  1/14 (7.14%) 
Stomach pain  0/40 (0.00%)  1/14 (7.14%) 
Vomiting  6/40 (15.00%)  4/14 (28.57%) 
General disorders     
Chills  3/40 (7.50%)  1/14 (7.14%) 
Edema face  5/40 (12.50%)  0/14 (0.00%) 
Edema limbs  4/40 (10.00%)  1/14 (7.14%) 
Facial pain  2/40 (5.00%)  0/14 (0.00%) 
Fatigue  24/40 (60.00%)  9/14 (64.29%) 
Fever  2/40 (5.00%)  0/14 (0.00%) 
Flu like symptoms  0/40 (0.00%)  1/14 (7.14%) 
Non-cardiac chest pain  5/40 (12.50%)  1/14 (7.14%) 
Pain  8/40 (20.00%)  2/14 (14.29%) 
Immune system disorders     
Allergic reaction  2/40 (5.00%)  0/14 (0.00%) 
Infections and infestations     
Infections and infestations  1/40 (2.50%)  1/14 (7.14%) 
Lung infection  0/40 (0.00%)  1/14 (7.14%) 
Investigations     
Activated partial thromboplastin time prolonged  0/40 (0.00%)  1/14 (7.14%) 
Alanine aminotransferase increased  10/40 (25.00%)  4/14 (28.57%) 
Alkaline phosphatase increased  7/40 (17.50%)  0/14 (0.00%) 
Aspartate aminotransferase increased  9/40 (22.50%)  5/14 (35.71%) 
CD4 lymphocytes decreased  1/40 (2.50%)  1/14 (7.14%) 
Creatinine increased  2/40 (5.00%)  1/14 (7.14%) 
INR increased  0/40 (0.00%)  1/14 (7.14%) 
Lymphocyte count decreased  6/40 (15.00%)  3/14 (21.43%) 
Neutrophil count decreased  4/40 (10.00%)  0/14 (0.00%) 
Platelet count decreased  7/40 (17.50%)  0/14 (0.00%) 
Weight loss  2/40 (5.00%)  3/14 (21.43%) 
White blood cell decreased  4/40 (10.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  10/40 (25.00%)  3/14 (21.43%) 
Dehydration  0/40 (0.00%)  1/14 (7.14%) 
Hyperglycemia  11/40 (27.50%)  2/14 (14.29%) 
Hyperkalemia  6/40 (15.00%)  1/14 (7.14%) 
Hypoalbuminemia  3/40 (7.50%)  0/14 (0.00%) 
Hypocalcemia  2/40 (5.00%)  3/14 (21.43%) 
Hyponatremia  4/40 (10.00%)  2/14 (14.29%) 
Hypophosphatemia  2/40 (5.00%)  2/14 (14.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  4/40 (10.00%)  3/14 (21.43%) 
Back pain  7/40 (17.50%)  2/14 (14.29%) 
Chest wall pain  3/40 (7.50%)  2/14 (14.29%) 
Generalized muscle weakness  2/40 (5.00%)  0/14 (0.00%) 
Myalgia  4/40 (10.00%)  1/14 (7.14%) 
Pain in extremity  2/40 (5.00%)  0/14 (0.00%) 
Nervous system disorders     
Dizziness  1/40 (2.50%)  4/14 (28.57%) 
Dysgeusia  5/40 (12.50%)  2/14 (14.29%) 
Headache  16/40 (40.00%)  4/14 (28.57%) 
Peripheral motor neuropathy  1/40 (2.50%)  1/14 (7.14%) 
Peripheral sensory neuropathy  4/40 (10.00%)  0/14 (0.00%) 
Somnolence  0/40 (0.00%)  1/14 (7.14%) 
Psychiatric disorders     
Anxiety  2/40 (5.00%)  1/14 (7.14%) 
Depression  2/40 (5.00%)  2/14 (14.29%) 
Insomnia  3/40 (7.50%)  1/14 (7.14%) 
Libido decreased  0/40 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders     
Urinary tract pain  0/40 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  0/40 (0.00%)  1/14 (7.14%) 
Aspiration  1/40 (2.50%)  1/14 (7.14%) 
Bronchopulmonary hemorrhage  0/40 (0.00%)  1/14 (7.14%) 
Cough  4/40 (10.00%)  5/14 (35.71%) 
Dyspnea  12/40 (30.00%)  6/14 (42.86%) 
Epistaxis  1/40 (2.50%)  3/14 (21.43%) 
Hoarseness  1/40 (2.50%)  1/14 (7.14%) 
Pleural effusion  4/40 (10.00%)  0/14 (0.00%) 
Wheezing  0/40 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders     
Alopecia  3/40 (7.50%)  1/14 (7.14%) 
Dry skin  3/40 (7.50%)  1/14 (7.14%) 
Nipple sensitivity  0/40 (0.00%)  1/14 (7.14%) 
Palmar-plantar erythrodysesthesia syndrome  0/40 (0.00%)  1/14 (7.14%) 
Pruritus  2/40 (5.00%)  0/14 (0.00%) 
Rash acneiform  3/40 (7.50%)  1/14 (7.14%) 
Rash maculo-papular  12/40 (30.00%)  2/14 (14.29%) 
Skin erosion  0/40 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Hot flashes  1/40 (2.50%)  1/14 (7.14%) 
Hypertension  3/40 (7.50%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA (8.1)
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: Dr. Stuart Wong
Organization: University of Chicago Comprehensive Cancer Center
Phone: 773-702-9311
EMail: swong@mcw.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00859937     History of Changes
Other Study ID Numbers: NCI-2009-01165
NCI-2009-01165 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000636685
UCCRC-16691B
16691B ( Other Identifier: University of Chicago Comprehensive Cancer Center )
8271 ( Other Identifier: CTEP )
N01CM00032 ( U.S. NIH Grant/Contract )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2009
First Posted: March 11, 2009
Results First Submitted: June 19, 2014
Results First Posted: April 3, 2015
Last Update Posted: April 20, 2018