Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).
Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
- •Documented KIT aberration
- •Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- •Total serum bilirubin ≤ 1.5 x ULN
- •Absolute neutrophil count (ANC) ≥ 1500/µL
- •Platelets ≥ 100,000/µL
- •Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
- •Serum calcium ≤ 12.0 mg/dL
- •Serum creatinine ≤ 1.5 x ULN
- •Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
- •May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
- •At least one measurable lesion by RECIST criteria
- •ECOG PS 0-2
排除标准
- •Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- •History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
- •Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥
- •QTc > 470 msec on baseline EKG.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Nilotinib
Nilotinib 400 mg (2 capsules) PO BID q 28 days
干预措施: Nilotinib (Drug)
结局指标
主要结局
response rate
时间窗: 1~2 year
次要结局
未报告次要终点
研究者
Jeeyun Lee
Samsung medical center
Samsung Medical Center