The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Park Ridge, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
Time frame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
Safety and tolerability of XL820
Time frame: Assessed at each visit
Progression-free survival, duration of response, and overall survival
Time frame: Assessed until progression
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Time frame: Assessed during periodic visits
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