NL-OMON44339撤回2 期
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - INCB 54828-202
Quintiles0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Men and women, aged 18 or older.;* Histologically or cytologically confirmed cholangiocarcinoma. Subjects will be assigned to 1 of 3 cohorts:;a. Cohort A: FGFR2 translocations.;b. Cohort B: other FGF/FGFR alterations.;c. Cohort C (US only): negative for FGF/FGFR alterations.;* Radiographically measurable disease per RECIST v1.1.;* Documentation of FGF/FGFR gene alteration status.;* Documented disease progression after at least 1 line of prior systemic therapy.;* ECOG performance status of 0 to 2.;* Life expectancy * 12 weeks.
排除标准
- •* Prior receipt of a selective FGFR inhibitor.;* History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.;* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.;* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
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