KCT0008415招募中Unknown
A phase II study of imatinib dose escalation to 800 mg/day in Asian patients with metastatic or unresectable GIST harboring KIT exon 9 mutation
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Age 18 or older
- •2. Histologically confirmed metastatic or unresectable GIST with CD117(+), DOG-1 (+), or KIT mutation
- •3. ECOG PS 0~2
- •4. Primary mutation at KIT exon 9
- •5. Imatinib treatment for less than 4 weeks from the first dose at 400 mg per day
- •6. No prior use of tyrosine kinase inhibitors (but, patients who have recurrence 6 months after completion of adjuvant imatinib at a dose of 400 mg per day can be enrolled in this study)
- •7. At least one evaluable disease by RECIST v1.0
- •8.Resolution of all toxic effects of prior treatments (chemotherapy, surgery, RFA, radiotherapy, and/or TACE)
- •9. Adequate bone marrow function as defined by platelets = 75 x 109/L and neutrophils = 1.5 x 109/L within 1 week prior to the first dose of imatinib at 400 mg per day
- •10. Adequate renal function, with serum creatinine < 1.5 x ULN within 1 week prior to the first dose of imatinib at 400 mg per day
- •11. Adequate hepatic function with serum total bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases within 1 week prior to the first dose of imatinib at 400 mg per day
- •12. No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer except where treated with curative intent > 5 years previously without evidence of relapse
- •13. Provision of a signed written informed consent
排除标准
- •1. Severe co-morbid illness and/or active infections
- •2. Pregnant or lactating women
- •3. History of other malignancies except basal cell carcinoma and carcinoma in situ of uterine cervix
- •4. CNS metastasis
- •5. Clinically significant bleeding in GI tract
- •6. GI obstruction or malabsorption
- •7. Known hypersensitivity to imatinib
研究者
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