JPRN-jRCT2080225236暂停1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-Tumour Activity of Adavosertib (AZD1775) in Japanese Patients with Advanced Solid Tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 12
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
- >= 20age old 至 <= 120age old（—）
- 性别
- All
入选标准
- •Japanese patients 20 years or more of age at the time of study entry
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0,1
- •Adequate bone marrow reserve or organ function
- •Female patients who are not of child-bearing potential, and fertile females of childbearing potential who agree to use adequate contraceptive measures
- •Male patients should be willing to use barrier contraception
- •Predicted life expectancy 12 weeks or more
- •Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable
- •Measurable or non-measurable disease according to RECIST v1.1
排除标准
- •Use of anti-cancer treatment drug during the past 21 days or 5 half-lives (whichever is shorter) prior to the first dose of adavosertib
- •Use of an investigational drug during the past 30 days or 5 half-lives (whichever is longer) prior to the first dose of the study treatment
- •Common Terminology Criteria for Adverse Events (CTCAE) Grade >1 toxicity from prior therapy
- •Inability to swallow oral medication or any other condition that may impact adavosertib intake/absorption
- •Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases
- •Any of the cardiac diseases currently or within the last 6 months
- •Any underlying medical condition that would impair the patient's ability to receive study treatment
- •Other invasive malignancy within 5 years prior to the first dose of study drug except for non-invasive malignancies
研究者
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