Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation

Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation

Gastrointestinal Stromal Tumor

Active, not recruiting

2

Start Date 03/01/2012

Age of Trial (yrs) 12.2

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

AMC1102 KENEDI

Asan Medical Center

Yoon-Koo Kang, Md, PhD +82-2-3010-3230 ykkang@amc.seoul.kr Min-Hee Ryu, MD, PhD +82-2-3010-5935 miniryu@amc.seoul.kr

Oral

Intervention Details:

Drug: imatinib
The patients will receive 400 mg per day of imatinib for 4 weeks, and then 600mg per day (300 mg po bid) for 4 weeks if tolerable to 400 mg per day, and then 800 mg per day (400 mg po bid)

Detailed Description:

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.