JPRN-jRCT2080225109已完成2 期
A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations - RAGNAR
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a
入排标准
- 年龄范围
- >= 6age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
- •- Measurable disease
- •- Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
- •- Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening
排除标准
- •- Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
- •- The presence of FGFR gatekeeper and resistance mutations
- •- Histologic demonstration of urothelial carcinoma
- •- Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
- •- For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
- •- Active malignancies other than for disease requiring therapy
研究者
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