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

This study has been terminated.
(Lack of efficacy - Futility endpoint reached)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier:
NCT01391611
First received: July 8, 2011
Last updated: February 22, 2017
Last verified: December 2016
Results First Received: December 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor (GIST)
Intervention: Drug: Pazopanib

  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
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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
  Description
Pazopanib Arm Pazopanib: 800 mg; PO

Participant Flow:   Overall Study
    Pazopanib Arm
STARTED   25 
COMPLETED   3 
NOT COMPLETED   22 



  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.
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Reporting Groups
  Description
Pazopanib Arm Pazopanib: 800 mg; PO

Baseline Measures
   Pazopanib Arm 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 59 
 (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
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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
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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
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  More Information
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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
e-mail: kganjoo@stanford.edu



Responsible Party: Kristen Ganjoo, Stanford University
ClinicalTrials.gov 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 )
Study First Received: July 8, 2011
Results First Received: December 19, 2016
Last Updated: February 22, 2017