Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC (TOP0801)

This study has been terminated.
(Poor Accrual)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00787267
First received: November 6, 2008
Last updated: December 19, 2014
Last verified: December 2014
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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
This study opened to enrollment in November 2008 and closed in October 2011 due to slow accrual. Subjects were enrolled at 3 sites: Duke University Medical Center, Durham VA Medical Center, and the University of Minnesota. All subjects were enrolled in Stage 1, in which prior knowledge of each subject's tumoral Src-activity was not known.

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 Dasatinib: 70 mg PO twice daily until progression.

Participant Flow:   Overall Study
    Dasatinib  
STARTED     37 [1]
COMPLETED     25 [2]
NOT COMPLETED     12  
Screen failure/Ineligible                 10  
No Reason Provided                 1  
Withdrawal by Subject                 1  
[1] Signed a consent form
[2] Received at least one dose of study drug



  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.
All consented subjects included in baseline analysis.

Reporting Groups
  Description
Dasatinib Dasatinib: 70 mg PO twice daily until progression.

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  37  
Age  
[units: years]
Mean ± Standard Deviation
  61.7  ± 8.0  
Gender  
[units: participants]
 
Female     18  
Male     19  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     8  
White     28  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     37  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Response   [ Time Frame: 2 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Progression and survival every 6 months ]

3.  Secondary:   Grade 3-5 Toxicity Associated With Dasatinib Treatment   [ Time Frame: Duration of dasatinib treatment plus 30 days ]

4.  Secondary:   Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.   [ Time Frame: 2 years ]

5.  Secondary:   Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.   [ 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: Michael Kelley , MD
Organization: Duke University Medical Center
phone: 919-286-0411 ext 7326
e-mail: kelleym@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00787267     History of Changes
Other Study ID Numbers: Pro00008303
Study First Received: November 6, 2008
Results First Received: December 19, 2014
Last Updated: December 19, 2014
Health Authority: United States: Institutional Review Board