A Phase II Study of TAS-117 in Advanced Solid Tumors With PI3K/AKT Gene Aberration (Part of K-BASKET Trial; Korea-Biomarker-driven Multi-arm Drug-screening, Knowledge and Evidence-generating Targeted Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
- •Progressive disease who failed to previous standard treatment.
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Able to take medications orally
- •Adequate organ function
- •A life expectancy of at least 60 days
排除标准
- •Previous treatment with anti-PI3K or AKT directed therapies
- •Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
- •History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
- •Current evidence of retinopathy that requires ophthalmological therapy.
- •History or current evidence of cardiac arrhythmia and/or conduction abnormality.
- •Treatment with any of the following within the specified time frame prior to study drug administration:
- •Major surgery within prior 4 weeks
- •Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
- •Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
- •A serious illness or medical condition(s)
- •Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
- •Patients with the risk of hypokalemia
- •Receiving oral steroid medication.
- •Pregnant or lactating female
研究组 & 干预措施
TAS-117
TAS-117, 16mg, orally, daily
干预措施: TAS-117 (Drug)
结局指标
主要结局
overall response rate
时间窗: 2 months
次要结局
未报告次要终点
研究者
Minkyu Jung
Assistant Professor
Yonsei University