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

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. Identifier: NCT01068769
Recruitment Status : Active, not recruiting
First Posted : February 15, 2010
Results First Posted : February 24, 2014
Last Update Posted : March 1, 2018
Brigham and Women's Hospital
Massachusetts General Hospital
Fox Chase Cancer Center
Oregon Health and Science University
Information provided by (Responsible Party):
Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Intervention: Drug: regorafenib

  Participant Flow

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

Participant Flow:   Overall Study
Ineligible                1 

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (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

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 ]

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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

  More Information

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

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

Responsible Party: Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center Identifier: NCT01068769     History of Changes
Other Study ID Numbers: 09-400
First Submitted: February 12, 2010
First Posted: February 15, 2010
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: March 1, 2018