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Dasatinib in Advanced Squamous Cell Lung Cancer

This study has been terminated.
(Safety issues/concerns per DF/HCC PI)
Sponsor:
Information provided by (Responsible Party):
Bruce Johnson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01491633
First received: October 5, 2011
Last updated: June 14, 2014
Last verified: June 2014
Results First Received: May 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous 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
No text entered.

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 140 mg by mouth each day

Dasatinib: 140 mg orally, daily in 28 day cycles


Participant Flow:   Overall Study
    Dasatinib  
STARTED     5  
COMPLETED     0  
NOT COMPLETED     5  



  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

Dasatinib 140 mg by mouth each day

Dasatinib: 140 mg orally, daily in 28 day cycles


Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Mean ( Full Range )
  59  
  ( 55 to 78 )  
Gender  
[units: participants]
 
Female     2  
Male     3  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Types and Frequency of DDR2 Mutations   [ Time Frame: 2 years ]

3.  Secondary:   Survival   [ Time Frame: 2 years ]

4.  Secondary:   Toxicities   [ Time Frame: 2 years ]

5.  Post-Hoc:   Time on Study   [ 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
Due to the toxicity of the study agent no subjects were evaluable for response


  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.


Results Point of Contact:  
Name/Title: Dr. Peter Hammerman
Organization: Dana-Farber Cancer Institute
phone: 617-632-3000
e-mail: phammerman@partners.org


Publications of Results:

Responsible Party: Bruce Johnson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01491633     History of Changes
Other Study ID Numbers: 11-142
Study First Received: October 5, 2011
Results First Received: May 14, 2014
Last Updated: June 14, 2014
Health Authority: United States: Institutional Review Board