JPRN-jRCT2080225127招募中1 期
A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors
Eli Lilly and Company / ICCC :Medpace Japan KK0 个研究点目标入组 100 人开始时间: 2020年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- >= 6month old 至 <= 21age old（—）
- 性别
- All
入选标准
- •Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
- •-Evidence of an activating RET gene alteration in the tumor and/ or blood
- •-Measurable or non-measurable disease
- •-Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50.
- •-Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days.
- •-Adequate hematologic, hepatic and renal function.
- •-Ability to receive study drug therapy orally or via gastric access
- •-Willingness of men and women of reproductive potential to observe conventional and effective birth control
排除标准
- •-Major surgery within two weeks prior to planned start of LOXO-292.
- •-Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292.
- •-Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
- •-Clinically significant active malabsorption syndrome.
- •-Pregnancy or lactation
- •-Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292).
- •-Uncontrolled symptomatic hypercalcemia or hypocalcemia.
- •-Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet SF and OraPlus, for participants who will receive LOXO-292 suspension.
- •-Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).
研究者
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