NCT04003623终止2 期
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.
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 confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
- •Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
- •Documentation of an FGFR1-3 gene mutation or translocation.
- •Objective disease progression after at least 1 prior therapy.
- •Not eligible or able to participate in any other Incyte-sponsored clinical trial.
排除标准
- •Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
- •Prior receipt of a selective FGFR inhibitor.
- •Current evidence of clinically significant corneal or retinal disorder.
- •History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
研究组 & 干预措施
Pemigatinib
Experimental
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 6 months
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
次要结局
- Disease Control Rate (DCR)(Up to approximately 6 months)
- Duration of Response (DOR)(Up to approximately 6 months)
- Progression-free Survival (PFS)(Up to approximately 6 months)
- Overall Survival (OS)(Up to approximately 6 months)
- Number of Treatment-related Adverse Events(Up to approximately 6 months)
研究者
研究点 (11)
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