NCT04507503Approved For Marketing不适用
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 16
研究概览
简要总结
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
详细描述
This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.
研究设计
- 研究类型
- Expanded Access
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
- •Provide written informed consent.
- •>18 years of age.
- •Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.
- •Patient has failed standard therapy or standard therapy is not tolerated.
- •Has measurable or non-measurable lesion(s).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Adequate organ function.
排除标准
- •History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
- •History and/or current evidence of clinically significant ectopic mineralization/calcification.
- •History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
- •A serious illness or medical condition(s)
- •Pregnant or breast-feeding female
研究者
研究点 (16)
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