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Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Fox Chase Cancer Center
Oregon Health and Science University
Bayer
Information provided by (Responsible Party):
Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier:
NCT01068769
First received: February 12, 2010
Last updated: March 22, 2017
Last verified: March 2017
History of Changes
Results First Received: January 9, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Intervention: Drug: regorafenib

  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
Participants were enrolled at three sites between February and December, 2010.

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
Regorafenib Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Participant Flow:   Overall Study
    Regorafenib
STARTED   34 
COMPLETED   33 
NOT COMPLETED   1 
Ineligible                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.
Eligible patients were included in the baseline analysis population

Reporting Groups
  Description
Regorafenib Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Baseline Measures
   Regorafenib 
Overall Participants Analyzed 
[Units: Participants]
 		 33 
Age 
[Units: Years]
Median (Full Range) 		 56 
 (25 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      14  42.4% 
Male      19  57.6% 
Region of Enrollment 
[Units: Participants]
 		 
United States   33 


  Outcome Measures
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1.  Primary:   Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control   [ Time Frame: 2 years ]
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2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From date of enrollment until date of first documented progression or date of death from any cause, whichever came first ]
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Measure Type Secondary
Measure Title Progression-free Survival (PFS)
Measure Description Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).
Time Frame From date of enrollment until date of first documented progression or date of death from any cause, whichever came first  

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
Regorafenib Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Measured Values
   Regorafenib 
Participants Analyzed 
[Units: Participants]
 		 33 
Progression-free Survival (PFS) 
[Units: Months]
Median (95% Confidence Interval) 		 10.0 
 (8.3 to 14.9) 

No statistical analysis provided for Progression-free Survival (PFS)




  Serious Adverse Events
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  Other Adverse Events
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  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. Suzanne George
Organization: Dana-Farber Cancer Institute
phone: 617-632-5204
e-mail: sgeorge2@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier: NCT01068769     History of Changes
Other Study ID Numbers: 09-400
Study First Received: February 12, 2010
Results First Received: January 9, 2014
Last Updated: March 22, 2017