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Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00459342
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : December 24, 2013
Last Update Posted : May 15, 2014
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 Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Intervention Drug: dasatinib
Enrollment 35

Recruitment Details Recruitment Period: March 22, 2007 to April 20, 2009. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Dasatinib
Hide Arm/Group Description Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 35
Completed 34
Not Completed 1
Reason Not Completed
Not eligible             1
Arm/Group Title Dasatinib
Hide Arm/Group Description Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
69
(51 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
11
  31.4%
Male
24
  68.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
2
   5.7%
Not Hispanic or Latino
33
  94.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   8.6%
White
31
  88.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
Hide Description Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 34 eligible study participants enrolled, four participants were not evaluable for response.
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Partial Remission 1
Stable Disease 12
Progressive Disease 17
2.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the duration of time from start of treatment to time of progression or death.
Time Frame Time from start of treatment to time of progression or death, assessed at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Four participants were not evaluable for response.
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
1.36
(0.16 to 17.2)
3.Secondary Outcome
Title Overall Survival
Hide Description Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.
Time Frame Time from start of treatment to death from any cause, assessed up to 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Progression
Hide Description Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame 29 weeks
Adverse Event Reporting Description Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
 
Arm/Group Title Dasatinib
Hide Arm/Group Description Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Dasatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib
Affected / at Risk (%) # Events
Total   25/35 (71.43%)    
Blood and lymphatic system disorders   
Hypoxia  1  1/35 (2.86%)  1
Thromboembolic event  1  2/35 (5.71%)  2
Lymphocyte count decreased  1  1/35 (2.86%)  1
Anemia  1  2/35 (5.71%)  2
Neutrophil count decreased  1  1/35 (2.86%)  1
Cardiac disorders   
Atrial fibrillation  1  1/35 (2.86%)  1
General disorders   
Fatigue  1  2/35 (5.71%)  2
Non-cardiac chest pain  1  1/35 (2.86%)  1
Death NOS  1  1/35 (2.86%)  1
Headache  1  1/35 (2.86%)  1
Abdominal pain  1  1/35 (2.86%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/35 (5.71%)  2
Hyponatremia  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  15/35 (42.86%)  17
Pleural effusion  1  6/35 (17.14%)  6
Lung infection  1  3/35 (8.57%)  4
Pleuritic pain  1  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dasatinib
Affected / at Risk (%) # Events
Total   34/35 (97.14%)    
Blood and lymphatic system disorders   
Alanine aminotransferase increased  1  3/35 (8.57%)  3
Anemia  1  6/35 (17.14%)  9
Blood and lymphatic system disorders  1  1/35 (2.86%)  1
Hemolysis  1  2/35 (5.71%)  2
Hypertension  1  5/35 (14.29%)  5
Hypoxia  1  2/35 (5.71%)  2
Lymphocyte count decreased  1  11/35 (31.43%)  13
Neutrophil count decreased  1  1/35 (2.86%)  1
Platelet count decreased  1  1/35 (2.86%)  1
Cardiac disorders   
Palpitations  1  1/35 (2.86%)  1
Paroxysmal atrial tachycardia  1  1/35 (2.86%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/35 (2.86%)  1
Tinnitus  1  1/35 (2.86%)  1
Endocrine disorders   
Aspartate aminotransferase increased  1  3/35 (8.57%)  3
Hypoalbuminemia  1  1/35 (2.86%)  1
Eye disorders   
Conjunctivitis  1  1/35 (2.86%)  1
Eye pain  1  1/35 (2.86%)  1
Gastrointestinal disorders   
Anal hemorrhage  1  1/35 (2.86%)  1
Constipation  1  8/35 (22.86%)  8
Diarrhea  1  15/35 (42.86%)  17
Dysphagia  1  3/35 (8.57%)  4
Flatulence  1  2/35 (5.71%)  2
Gastritis  1  3/35 (8.57%)  3
Nausea  1  21/35 (60.00%)  22
Oral hemorrhage  1  1/35 (2.86%)  1
Stomach pain  1  1/35 (2.86%)  1
Vomiting  1  7/35 (20.00%)  7
General disorders   
Abdominal pain  1  2/35 (5.71%)  2
Back pain  1  6/35 (17.14%)  6
Epistaxis  1  1/35 (2.86%)  1
Facial pain  1  1/35 (2.86%)  1
Fatigue  1  28/35 (80.00%)  39
Headache  1  9/35 (25.71%)  9
Non-cardiac chest pain  1  2/35 (5.71%)  2
Pain  1  9/35 (25.71%)  10
Immune system disorders   
Allergic rhinitis  1  2/35 (5.71%)  2
Infections and infestations   
Fever  1  3/35 (8.57%)  5
Injury, poisoning and procedural complications   
Burn  1  1/35 (2.86%)  1
Metabolism and nutrition disorders   
Anorexia  1  16/35 (45.71%)  17
Hyperglycemia  1  5/35 (14.29%)  5
Hypocalcemia  1  2/35 (5.71%)  2
Hypokalemia  1  2/35 (5.71%)  2
Hypomagnesemia  1  2/35 (5.71%)  2
Hyponatremia  1  1/35 (2.86%)  1
Hypothyroidism  1  1/35 (2.86%)  1
Weight loss  1  2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders   
Arthritis  1  2/35 (5.71%)  2
Bone pain  1  1/35 (2.86%)  1
Chest wall pain  1  1/35 (2.86%)  1
Dysgeusia  1  3/35 (8.57%)  3
Myalgia  1  1/35 (2.86%)  1
Myositis  1  1/35 (2.86%)  1
Neck pain  1  1/35 (2.86%)  1
Pain in extremity  1  3/35 (8.57%)  3
Pelvic pain  1  1/35 (2.86%)  1
Nervous system disorders   
Dizziness  1  2/35 (5.71%)  2
Peripheral motor neuropathy  1  1/35 (2.86%)  1
Peripheral sensory neuropathy  1  2/35 (5.71%)  2
Voice alteration  1  2/35 (5.71%)  2
Psychiatric disorders   
Anxiety  1  6/35 (17.14%)  7
Depression  1  5/35 (14.29%)  5
Insomnia  1  7/35 (20.00%)  8
Renal and urinary disorders   
Bladder infection  1  1/35 (2.86%)  1
Urinary frequency  1  1/35 (2.86%)  1
Urinary tract infection  1  2/35 (5.71%)  2
Reproductive system and breast disorders   
Nipple deformity  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  21/35 (60.00%)  25
Dyspnea  1  21/35 (60.00%)  32
Laryngeal edema  1  1/35 (2.86%)  1
Lung infection  1  3/35 (8.57%)  4
Pleural effusion  1  18/35 (51.43%)  26
Pleuritic pain  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders - (Other)  1  2/35 (5.71%)  2
Sinus disorder  1  1/35 (2.86%)  1
Sinusitis  1  1/35 (2.86%)  2
Tracheal obstruction  1  1/35 (2.86%)  1
Upper respiratory infection  1  1/35 (2.86%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  1/35 (2.86%)  1
Dry skin  1  2/35 (5.71%)  2
Edema face  1  4/35 (11.43%)  5
Edema limbs  1  3/35 (8.57%)  3
Erythema multiforme  1  1/35 (2.86%)  1
Flushing  1  2/35 (5.71%)  2
Hyperhidrosis  1  1/35 (2.86%)  1
Pruritus  1  3/35 (8.57%)  3
Rash acneiform  1  2/35 (5.71%)  2
Rash maculo-papular  1  8/35 (22.86%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Name/Title: Faye Johnson, MD / Associate Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459342     History of Changes
Other Study ID Numbers: NCI-2009-00225
NCI-2009-00225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000538668
2006-0593
2006-0593 ( Other Identifier: M D Anderson Cancer Center )
7798 ( Other Identifier: CTEP )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: April 9, 2007
First Posted: April 11, 2007
Results First Submitted: November 1, 2013
Results First Posted: December 24, 2013
Last Update Posted: May 15, 2014