NCT02776878Unknown不适用
A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor
Peking University Cancer Hospital & Institute7 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 7
- 主要终点
- Progression-free survive, calculated from registration until progression or death
研究概览
简要总结
The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor
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 confirmed recurrent/metastatic gastrointestinal stromal tumor (GIST). Immunohistochemically, the detection KIT and/or DOG-1 are/is positive
- •Patients must have measurable disease meeting the requirement of RECIST 1.1
- •Received the gene mutation detection of c - kit/PDGFRA
- •Subjects with mutation in exon 11, in exon 9 and wild type c-kit/PDGFRA have failed to imatinib and sunitinib
- •Subjects with primary mutation in exon 17 or 18 have failed to imatinib
- •Subjects with primary mutation in exon 11 and secondary mutation in exon 17 or 18 have failed to imatinib
- •Subjects with mutation in exon 18 of PDGFRA,have received TKI or not
- •Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
- •Expected OS ≥3 months
- •Ability to understand and the willingness to sign a written informed consent document
- •Subject will comply with the study procedures and therapy
排除标准
- •Local or metastatic GIST is resectable
- •Unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/PDGFRA
- •AST and/or ALT > 2.5 times ULN, or Bilirubin >1.5 times upper limit of normal (ULN)
- •Neutrophil count < 1.5 x 10^9/L, or Platelet count <75 x 10^9/L, or Hemoglobin<90g/L
- •Cr >1.5×ULN
- •Other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma
- •Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage
- •Within the past 5 years, subjects have one of the following disease: myocardial infarction, serious/instable angina pectoris, symptomatic congestive heart failure or cerebrovascular accident from coronary/peripheral artery bypass grafting
- •Known human immunodeficiency virus positivity
- •Joining in other trail
- •Women who are pregnant or lactating; No contraception for subject during childbearing period
- •Subject with other serious acute and chronic physical or mental problems, or laboratory abnormality, will increase the risks associated with trail or drug. It will also interference the judgment of the results. In the judgment of the investigator, subject is inadequate to participant the study
研究组 & 干预措施
Dasatinib
Experimental
Dasatinib is given orally 50 mg 2 times a day for the first week, if subject is tolerate, then increased to 70 mg 2 times a day. Dasatinib will be continued until unacceptable toxicity and progression.
干预措施: dasatinib (Drug)
结局指标
主要结局
Progression-free survive, calculated from registration until progression or death
时间窗: 2 years
次要结局
- Overall survival, overall survival will be calculated from registration until death(2 years)
- Adverse drug reactions according to NCI CTCAE v4.0(2 years, Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v4.0.)
- Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria(2 years)
- Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(2 years)
研究者
Shen Lin
MD，PhD
Peking University Cancer Hospital & Institute
研究点 (7)
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