jRCT2080224739已完成1 期
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single Group Assignment, Open Label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adult subjects; age 20 years or more
- •Histologically or cytological confirmation of a solid, malignant tumor, excluding central nervous system (CNS) tumors and lymphoma, that is refractory to standard therapy or for which no standard of care regimen currently exists
- •Patients must have either at least one lesion that can be evaluable using RECIST v1.1 or patients with mCRPC must have measurable prostate specific antigen above normal limits (per local ranges)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Normotensive or well controlled blood pressure, with or without current antihypertensive treatment
- •Females of child-bearing potential must use 2 highly effective methods of contraception
- •Male patients should be willing to use barrier contraception
排除标准
- •Any investigational medicinal product or other systemic anticancer treatment within at least 4 weeks prior to the first dose of study treatment, or within 8 weeks after immunotherapy or other long half-life antibody therapy, whichever is the most appropriate and as judged by the Investigator
- •Evidence of recent or significant cardiovascular disease
- •Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at starting study treatment
- •History of seizures, CNS tumors or CNS metastasis
- •Active or prior documented autoimmune or inflammatory disorders within the past 3 years to the start of treatment
- •Patients with prior Grade3 immune-mediated reactions or more
- •Evidence of severe or uncontrolled systemic diseases
- •Inadequate bone marrow reserve or organ function
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD4635
- •History of hypersensitivity to AZD4635 or drugs with a similar chemical structure or class to AZD4635
- •Judgment by the Investigator that the patient should not participate in the study
结局指标
主要结局
-
safety -
次要结局
未报告次要终点
研究者
研究点 (1)
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