Ponatinib for Squamous Cell Lung and Head and Neck Cancers

This study has been terminated.
(FDA hold and toxicity associated with study drug)
Sponsor:
Information provided by (Responsible Party):
Peter S. Hammerman, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01761747
First received: September 26, 2012
Last updated: December 13, 2014
Last verified: December 2014
Results First Received: November 15, 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, Head and Neck Cancer
Intervention: Drug: ponatinib

  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
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Reporting Groups
  Description
Ponatinib Treatment Arm

Ponatinib taken by mouth daily

ponatinib


Participant Flow:   Overall Study
    Ponatinib Treatment Arm  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  



  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
Ponatinib Treatment Arm

Ponatinib taken by mouth daily

ponatinib


Baseline Measures
    Ponatinib Treatment Arm  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean ( Full Range )
  61  
  ( 37 to 74 )  
Gender  
[units: participants]
 
Female     0  
Male     3  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     3  
Region of Enrollment  
[units: participants]
 
United States     3  
Disease [1]
[units: participants]
  3  
[1] Non-small cell lung cancer



  Outcome Measures
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1.  Primary:   Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib   [ Time Frame: 2 years ]

2.  Secondary:   Prevalence of Specific FGFR Amplifications/Mutations in the Study Population   [ Time Frame: 2 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: 2 years ]

4.  Secondary:   Define Toxicities of Ponatinib   [ Time Frame: 2 years ]

5.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

6.  Secondary:   Disease Control   [ Time Frame: 2 years ]

7.  Secondary:   Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History   [ Time Frame: 2 years ]

8.  Secondary:   Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations   [ 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:  
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: 617-632-6335
e-mail: phammerman@partners.org


No publications provided


Responsible Party: Peter S. Hammerman, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01761747     History of Changes
Other Study ID Numbers: 12-327
Study First Received: September 26, 2012
Results First Received: November 15, 2014
Last Updated: December 13, 2014
Health Authority: United States: Food and Drug Administration