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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068769
First Posted: February 15, 2010
Last Update Posted: April 18, 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.
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
Results First Submitted: January 9, 2014  
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
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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 ]

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
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Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
    Regorafenib
Total, Serious Adverse Events   
# participants affected / at risk   31/33 (93.94%) 
Cardiac disorders   
Acute coronary syndrome † 1   
# participants affected / at risk   1/33 (3.03%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   4/33 (12.12%) 
Colitis † 1   
# participants affected / at risk   8/33 (24.24%) 
Diarrhea † 1   
# participants affected / at risk   3/33 (9.09%) 
Nausea † 1   
# participants affected / at risk   2/33 (6.06%) 
Vomiting † 1   
# participants affected / at risk   1/33 (3.03%) 
Gastrointestinal disorders - Other, specify † 1   
# participants affected / at risk   3/33 (9.09%) 
General disorders   
Fatigue † 1   
# participants affected / at risk   2/33 (6.06%) 
Investigations   
Blood bilirubin increased † 1   
# participants affected / at risk   1/33 (3.03%) 
CD4 lymphocytes decreased † 1   
# participants affected / at risk   1/33 (3.03%) 
Lipase increased † 1   
# participants affected / at risk   2/33 (6.06%) 
Lymphocyte count decreased † 1   
# participants affected / at risk   1/33 (3.03%) 
Neutrophil count decreased † 1   
# participants affected / at risk   1/33 (3.03%) 
Serum amylase increased † 1   
# participants affected / at risk   1/33 (3.03%) 
Weight loss † 1   
# participants affected / at risk   2/33 (6.06%) 
Metabolism and nutrition disorders   
Anorexia † 1   
# participants affected / at risk   1/33 (3.03%) 
Hyperuricemia † 1   
# participants affected / at risk   2/33 (6.06%) 
Hyponatremia † 1   
# participants affected / at risk   1/33 (3.03%) 
Hypophosphatemia † 1   
# participants affected / at risk   6/33 (18.18%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1   
# participants affected / at risk   2/33 (6.06%) 
Buttock pain † 1   
# participants affected / at risk   2/33 (6.06%) 
Myalgia † 1   
# participants affected / at risk   2/33 (6.06%) 
Pain in extremity † 1   
# participants affected / at risk   2/33 (6.06%) 
Psychiatric disorders   
Insomnia † 1   
# participants affected / at risk   2/33 (6.06%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome † 1   
# participants affected / at risk   12/33 (36.36%) 
Pruritus † 1   
# participants affected / at risk   1/33 (3.03%) 
Rash maculo-papular † 1   
# participants affected / at risk   4/33 (12.12%) 
Vascular disorders   
Hypertension † 1   
# participants affected / at risk   13/33 (39.39%) 
Thromboembolic event † 1   
# participants affected / at risk   1/33 (3.03%) 
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE (4.0)




  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


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
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: April 18, 2017



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