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Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

This study has been terminated.
(Novartis is ending their research program for Nilotinib in GIST.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089595
First Posted: March 18, 2010
Last Update Posted: March 15, 2017
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.
Collaborator:
Novartis
Information provided by (Responsible Party):
Fox Chase Cancer Center
Results First Submitted: May 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: GIST
Metastatic Disease
Interventions: Drug: Nilotinib
Drug: Nilotinib with Imatinib

  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
During the period of February 2, 2009 through May 26, 2011, recruitment occur at oncology hospital.

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
Nilotinib Nilotinib 400 mg po bid
Nilotinib + Imatinib Nilotinib 400 mg BID with Imatinib 400 mg daily

Participant Flow:   Overall Study
    Nilotinib   Nilotinib + Imatinib
STARTED   2   3 
COMPLETED   2   3 
NOT COMPLETED   0   0 



  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
Nilotinib Nilotinib 400 mg po bid
Nilotinib + Imatinib Nilotinib 400 mg BID with Imatinib 400 mg daily
Total Total of all reporting groups

Baseline Measures
   Nilotinib   Nilotinib + Imatinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   3   5 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1  50.0%      2  66.7%      3  60.0% 
>=65 years      1  50.0%      1  33.3%      2  40.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  50.0%      1  33.3%      2  40.0% 
Male      1  50.0%      2  66.7%      3  60.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   3   5 


  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 6 months until death or for 5 years ]

2.  Secondary:   Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging   [ Time Frame: Every 8 weeks for up to 5 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
Trial ended early due to industry support of provision of nilotinib was discontinued.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Margaret von Mehren, Principal Investigator
Organization: Fox Chase Cancer Center
phone: 215-728-4300
e-mail: margaret.vonmehren@fccc.edu



Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01089595     History of Changes
Other Study ID Numbers: FER-SAR-023
First Submitted: January 28, 2010
First Posted: March 18, 2010
Results First Submitted: May 7, 2013
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017



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