Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00570401
First received: December 7, 2007
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dasatinib Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)

Participant Flow:   Overall Study
    Dasatinib  
STARTED     21  
COMPLETED     19  
NOT COMPLETED     2  
Adverse Event                 2  



  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.
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Reporting Groups
  Description
Dasatinib Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     8  
Gender  
[units: participants]
 
Female     13  
Male     8  



  Outcome Measures

1.  Primary:   Determine the Overall Objective Response   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Gregory Riely
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4199
e-mail: rielyg@mskcc.org


Publications of Results:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00570401     History of Changes
Obsolete Identifiers: NCT00590057
Other Study ID Numbers: Mskcc 06-143
P30CA008748 ( US NIH Grant/Contract Award Number )
MSKCC-06143
BMS-MSKCC-06143
Study First Received: December 7, 2007
Results First Received: December 16, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration