EUCTR2016-002422-36-BE进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women, aged 18 or older.
- •Histologically or cytologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma. Subjects
- •will be assigned to 1 of 3 cohorts:
- •a. Cohort A: FGFR2 translocations with a documented fusion partner in central laboratory report.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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.
研究者
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