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Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) (07060)

This study has been terminated.
(Stopped early for futility, unable to meet accrual goals)
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00782834
First received: October 29, 2008
Last updated: April 15, 2013
Last verified: April 2013
Results First Received: December 17, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Intervention: Drug: Nilotinib

  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
Patients were accrued between 7/03/2008 and 9/24/2009 at Fox Chase Cancer Center outpatient medical oncology clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Advanced GIST with measurable disease; previously treated with at least imatinib and sunitinib; a 5-day washout from prior tyrosine kinase inhibitor therapy. Normal cardiac function with LVEF 45% or >, no history of significant heart disease,arrhythmias,congenital long QT sydrome, heart block, MI within 12 mos of visit 1 or unstable angina, CHF

Reporting Groups
  Description
Nilotinib Arm All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle

Participant Flow for 2 periods

Period 1:   Screened Patients
    Nilotinib Arm  
STARTED     15  
COMPLETED     14 [1]
NOT COMPLETED     1  
[1] 1 pt ineligible d/t arrhythmia

Period 2:   Treatment Phase
    Nilotinib Arm  
STARTED     14  
COMPLETED     13  
NOT COMPLETED     1  
fibrous tumor not GIST                 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.

Screened:

Started: 15 patients Completed: 14 patients Comments: 1 patient deemed ineligible due to arrhythmia.

Treatment Phase:

Started: 14 patients Completed: 13 patients Comments: 1 patient on extensive pathology review was found to have a solitary fibrous tumor, not GIST.


Reporting Groups
  Description
Nilotinib Arm All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle

Baseline Measures
    Nilotinib Arm  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     4  
Gender  
[units: participants]
 
Female     4  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     13  
Primary Site of Cancer [1]
[units: Participants]
 
Stomach     6  
Small Bowel     5  
Colon     1  
Rectum     1  
Prior Tyrosine Kinase Inhibitor (TKI) [2]
[units: Participants]
 
IM and SU     11  
IM, SU and NA     1  
IM, SU, RT and CT     1  
[1] Stomach 6; Small bowel 5; Colon 1; Rectum 1
[2] Imatinib (IM) + Sunitinib (SU); Imatinib + Sunitinib + Nasatinib (NA); Imatinib +Sunitinib + Radiotherapy (RT) + Chemotherapy (CT)



  Outcome Measures
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1.  Primary:   Progression Free Survival Rate at 6 Months   [ Time Frame: 6 months ]

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


  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
The study failed to meet its accrual goals. Study terminated prior to accruing 17 subjects due to futility of meeting endpoint.


  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: Margaret von Mehren, M.D., Director of Sarcoma Oncology
Organization: Fox Chase Cancer Center
phone: 215-728-2814
e-mail: margaret.vonMehren@fccc.edu


No publications provided


Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00782834     History of Changes
Other Study ID Numbers: CAMN107DUS05T
Study First Received: October 29, 2008
Results First Received: December 17, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board