JPRN-jRCT2080224555已完成2 期
A Multicenter Phase II Basket-type Clinical Trial to Evaluate Efficacy and Safety of TAS-120 in Patients with Advanced Solid Malignancies with FGFR Alterations in Circulating Tumor DNA
ational Cancer Center Hospital East0 个研究点目标入组 26 人开始时间: 2019年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
TAS-120 demonstrated promising efficacy in refractory advanced solid malignancies with FGFR alterations in circulating tumor DNA with an acceptable toxicity profile.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Informed consent for participation in the study is obtained at the discretion of the patient.
- •2.The patient is 20 years of age or older on the date of informed consent.
- •3.Histologically or cytologically confirmed an unresectable advanced or recurrent solid malignancy without standard treatment remains.
- •4.The following genomic alteration is detected by analysis of blood sample using Guardant360:
- •I.FGFR fusion
- •II.FGFR amplification
- •III.FGFR mutation
- •5.The disease is measurable based on the Response Evaluation Criteria in Solid Tumours (RECIST) guidelines version 1.1
排除标准
- •1.History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
- •2.History and/or current evidence of ectopic mineralization/calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification.
- •3.Current evidence of corneal disorder/keratopathy including but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
- •4.History or current evidence of cardiac arrhythmia and/or conduction abnormality.
研究者
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