A Phase II Study of Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation
According to our previous prospective phase II study of imatinib 400 mg per day in
metastatic or unresectable GIST, hematologic and non-hematologic toxicities were more
frequent in Korean patients compared to the Western studies.7 It may be caused by relatively
higher exposure to imatinib per body surface area in Korean patients than in Western
population because the weight and height of Korean patients are relatively smaller than
Western people. So, we plan to start imatinib at 400 mg per day and then sequentially
escalate the doses of imatinib in this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival (PFS)
evaluated with Triphasic or dynamic CT scans of abdomen & pelvis, and other involved sites. Follow-up CT scans will be performed at 4 weeks and 12 weeks after the first dose of imatinib at 400 mg per day, and then every 3 months until disease using RECIST version 1.0
up to 24months
No
Yoon-Koo Kang, MD, PhD
Principal Investigator
Asan Medical Center
Korea: Food and Drug Administration
AMC1104
NCT01541709
March 2012
August 2016
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