A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue.
研究概览
简要总结
OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical Company, Ltd, and is currently undergoing clinical investigation at the National University Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic biomarker study is initiated and funded by the investigators, and will be conducted in conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic samples will be collected, stored and analysed at the local laboratory of the study site (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Solid Tumor
排除标准
- •Non advanced solid tumor
结局指标
主要结局
Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue.
时间窗: 1 year
Analysis
次要结局
- To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics(1 Year)