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: April 29, 2014
Last verified: December 2012
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459342     History of Changes
Other Study ID Numbers: NCI-2009-00225, NCI-2009-00225, CDR0000538668, 2006-0593, 2006-0593, 7798, N01CM62202, P30CA016672
Study First Received: April 9, 2007
Results First Received: November 1, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration