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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459342
First received: April 9, 2007
Last updated: November 1, 2013
Last verified: November 2013
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: March 22, 2007 to April 20, 2009. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dasatinib 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.

Participant Flow:   Overall Study
    Dasatinib  
STARTED     35  
COMPLETED     34  
NOT COMPLETED     1  
Not eligible                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dasatinib 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.

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Median ( Full Range )
  69  
  ( 51 to 79 )  
Gender  
[units: participants]
 
Female     11  
Male     24  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     33  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     31  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))   [ Time Frame: 12 weeks ]

2.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Time from start of treatment to time of progression or death, assessed at 2 months ]

3.  Secondary:   Overall Survival   [ Time Frame: Time from start of treatment to death from any cause, assessed up to 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Time to Progression   [ Time Frame: Up to 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


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
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459342     History of Changes
Other Study ID Numbers: NCI-2009-00225, 2006-0593, N01CM62202
Study First Received: April 9, 2007
Results First Received: November 1, 2013
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration