Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)

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: NCT01391611
Recruitment Status : Terminated (Lack of efficacy - Futility endpoint reached)
First Posted : July 12, 2011
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Pazopanib Arm Pazopanib: 800 mg; PO

Participant Flow:   Overall Study
    Pazopanib Arm

  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.
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Reporting Groups
Pazopanib Arm Pazopanib: 800 mg; PO

Baseline Measures
   Pazopanib Arm 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (27 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      10  40.0% 
Male      15  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      1   4.0% 
Not Hispanic or Latino      22  88.0% 
Unknown or Not Reported      2   8.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      1   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  12.0% 
White      18  72.0% 
More than one race      0   0.0% 
Unknown or Not Reported      3  12.0% 
Region of Enrollment 
[Units: Participants]
United States   25 

  Outcome Measures

1.  Primary:   Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)   [ Time Frame: 24 weeks ]

2.  Secondary:   Response Per Choi Criteria   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Kristen Ganjoo, MD
Organization: Stanford University Medical Center
phone: 650-725-6413

Responsible Party: Kristen Ganjoo, Stanford University Identifier: NCT01391611     History of Changes
Other Study ID Numbers: IRB-20636
RR2002/00017/09 ( Other Identifier: GlaxoSmithKline )
11-311 ( Other Identifier: Stanford IRB alternate )
GIST0003 ( Other Identifier: OnCore )
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: December 19, 2016
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017