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Ponatinib for Squamous Cell Lung and Head and Neck Cancers

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.
 
ClinicalTrials.gov Identifier: NCT01761747
Recruitment Status : Terminated (FDA hold and toxicity associated with study drug)
First Posted : January 7, 2013
Results First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Peter S. Hammerman, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer, Head and Neck Cancer
Intervention Drug: ponatinib
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description

Ponatinib taken by mouth daily

ponatinib

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Arm/Group Title Ponatinib Treatment Arm
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Ponatinib taken by mouth daily

ponatinib

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
61
(37 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 3 participants
3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants
3
[1]
Measure Description: Non-small cell lung cancer
1.Primary Outcome
Title Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib
Hide Description

Investigate the response rate of patients with previously treated lung or head and neck SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ponatinib Treatment Arm
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Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of subjects with response
0
2.Secondary Outcome
Title Prevalence of Specific FGFR Amplifications/Mutations in the Study Population
Hide Description Test tumor DNA using molecular assays to measure the frequency of FGFR amplifications and mutations in study patients
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had FGFR amplification, one with FGFR mutation
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Progression-free Survival
Hide Description Establish the progression-free survival of patients with SCC treated with ponatinib as defined by time to development of progression by RECIST criteria.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: days
44
(32 to 55)
4.Secondary Outcome
Title Define Toxicities of Ponatinib
Hide Description Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
2
5.Secondary Outcome
Title Overall Survival
Hide Description Measure the overall survival time of patients treated with ponatinib
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 3
Mean (Full Range)
Unit of Measure: days
276
(48 to 588)
6.Secondary Outcome
Title Disease Control
Hide Description Measure the disease control rate of patients treated with ponatinib
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of subjects
0
7.Secondary Outcome
Title Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History
Hide Description For subjects with FGFR amplifications and for FGFR mutations we will ascertain the age, sex, disease stage, prior response to treatment and smoking history from past medical records and measure whether there are differences in these variables among subjects with amplification versus mutation.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Too few subjects were enrolled on study to permit this outcome measure analysis.
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations
Hide Description Identify the response rate to ponatinib for FGFR specific FGFR amplifications/mutations.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
There were no observed responses on study so this outcome could not be determined.
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description:

Ponatinib taken by mouth daily

ponatinib

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description One individual withdrew consent the day after enrolling on study and was not dosed. Therefore only two individuals were evaluable for treatment-related toxicities.
 
Arm/Group Title Ponatinib Treatment Arm
Hide Arm/Group Description

Ponatinib taken by mouth daily

ponatinib

All-Cause Mortality
Ponatinib Treatment Arm
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ponatinib Treatment Arm
Affected / at Risk (%)
Total   1/2 (50.00%) 
Gastrointestinal disorders   
Pancreatits  1/2 (50.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ponatinib Treatment Arm
Affected / at Risk (%)
Total   2/2 (100.00%) 
Gastrointestinal disorders   
Diarrhea  1/2 (50.00%) 
Mucositis  1/2 (50.00%) 
Hepatitis  2/2 (100.00%) 
General disorders   
Fatigue  2/2 (100.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1/2 (50.00%) 
Myalgia  1/2 (50.00%) 
Nervous system disorders   
Neuropathy  1/2 (50.00%) 
Skin and subcutaneous tissue disorders   
Rash  1/2 (50.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Hammerman
Organization: Dana-Farber Cancer Institute
Phone: 617-632-6335
EMail: phammerman@partners.org
Layout table for additonal information
Responsible Party: Peter S. Hammerman, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01761747    
Other Study ID Numbers: 12-327
First Submitted: September 26, 2012
First Posted: January 7, 2013
Results First Submitted: November 15, 2014
Results First Posted: December 23, 2014
Last Update Posted: December 23, 2014