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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787267
Recruitment Status : Terminated (Poor accrual)
First Posted : November 7, 2008
Results First Posted : January 1, 2015
Last Update Posted : June 30, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Intervention: Drug: Dasatinib

  Participant Flow

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
Dasatinib Dasatinib: 70 mg PO twice daily until progression.

Participant Flow:   Overall Study
STARTED   37 [1] 
COMPLETED   25 [2] 
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

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
Dasatinib Dasatinib: 70 mg PO twice daily until progression.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 61.7  (8.0) 
[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

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

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

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


Responsible Party: Duke University Identifier: NCT00787267     History of Changes
Other Study ID Numbers: Pro00008303
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: December 19, 2014
Results First Posted: January 1, 2015
Last Update Posted: June 30, 2016