Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
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ClinicalTrials.gov Identifier: NCT01068769 |
Recruitment Status :
Completed
First Posted : February 15, 2010
Results First Posted : February 24, 2014
Last Update Posted : August 24, 2020
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Sponsor:
Suzanne George, MD
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
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Gastrointestinal Stromal Tumor |
Intervention |
Drug: regorafenib |
Enrollment | 34 |
Participant Flow
Recruitment Details | Participants were enrolled at three sites between February and December, 2010. |
Pre-assignment Details |
Arm/Group Title | Regorafenib |
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Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle |
Period Title: Overall Study | |
Started | 34 |
Completed | 33 |
Not Completed | 1 |
Reason Not Completed | |
Ineligible | 1 |
Baseline Characteristics
Arm/Group Title | Regorafenib | |
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Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle | |
Overall Number of Baseline Participants | 33 | |
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Eligible patients were included in the baseline analysis population
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 33 participants | |
56
(25 to 76)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 33 participants | |
Female |
14 42.4%
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Male |
19 57.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 33 participants |
33 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Suzanne George |
Organization: | Dana-Farber Cancer Institute |
Phone: | 617-632-5204 |
EMail: | 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 |
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: | August 24, 2020 |