This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib
Time frame: 24 weeks
DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)
Time frame: 24 weeks
Safety
Time frame: 24 weeks
PK profile
Time frame: 24 weeks
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Novartis Investigative Site
Niigata, Niigata, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan