NL-OMON49349已完成2 期
INCB 54828-201 A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations (FIGHT-201) - INCB 54828201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
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 99（—）
入选标准
- •* Men and women, aged 18 or older. For subjects in Japan, if the subject is
- •below the age of 20 years, voluntary agreement shall be obtained from the
- •subject and the representative or legal guardian using the written consent
- •form., * Histologically documented metastatic or surgically unresectable
- •urothelial carcinoma; may include primary site from urethra, ureters, upper
- •tract, renal pelvis, and bladder., * Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0, 1, or 2.
- •* Life expectancy * 12 weeks. , * Radiographically measurable disease per
- •RECIST v1.1., * Documented FGF/FGFR alteration and have either:
- •* have failed at least 1 previous treatment for their metastatic or surgically
- •unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy), or
- •* have not received chemotherapy for metastatic or surgically unresectable
- •urothelial carcinoma due to poor performance status (ie,
- •ECOG performance status of 2) and insufficient renal function (ie, creatinine
- •clearance < 60 mL/min or local guidelines)., * Willingness to avoid pregnancy
- •or fathering children. For subjects in Japan, female subjects who have been
- •amenorrhoeic for at least 12 months resulting from chemotherapy/radiotherapy
- •are considered of childbearing potential and should agree to use adequate
- •contraceptive measures.
排除标准
- •* Treatment with other investigational study drug for any indication for any
- •reason, or receipt of anticancer medications within 28 days before first dose
- •of study drug. Subjects must have recovered (Grade * 1 or at pretreatment
- •baseline) from AEs from previously administered therapies.
- •* Prior receipt of a selective FGFR inhibitor.
- •* Abnormal laboratory parameters:
- •* Total bilirubin * 1.5 × upper limit of normal (ULN; * 2.5 × ULN if Gilbert
- •syndrome or metastatic disease involving liver).
- •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 ×
- •ULN (AST and ALT > 5 × ULN in the presence of liver
- •metastases).
- •* Creatinine clearance * 30 mL/min based on Cockroft-Gault.
- •* Serum phosphate > institutional ULN.
- •* Serum calcium outside of the institutional normal range or serum
- •albumin-corrected calcium outside of the institutional normal range when serum
- •albumin is outside of the institutional normal range., * 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., * Known hypersensitivity or
- •severe reaction to INCB054828 or excipients of INCB054828 study drug., *
- •Inability or unwillingness to swallow INCB054828 or significant
- •gastrointestinal disorder(s) that could interfere with the absorption,
- •metabolism, or excretion of INCB054828., * Subjects who require hemodialysis.
研究者
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