Trial record 1 of 1 for:    A non-randomized, open label, multi-center Phase II study evaluating the efficacy and safety of regorafenib
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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: July 25, 2014
Last verified: July 2014
Results First Received: January 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   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  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 25 to 76 )  
Gender  
[units: participants]
 
Female     14  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures
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1.  Primary:   To Assess 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 ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: assessed every 8 weeks until progression ]


  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
No text entered.


  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


No publications provided


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: July 25, 2014
Health Authority: United States: Food and Drug Administration