NCT07643870尚未招募1 期
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 8
- 试验地点
- 2
研究概览
简要总结
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
详细描述
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
- •ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
- •Predicted life expectancy ≥ 12 weeks,
- •Adequate organ and marrow function,
- •Creatinine clearance ≥ 50 mL/min,
- •Regular bowel movements,
- •No cancer-associated cachexia (weight loss).
排除标准
- •History or presence of myopathy or raised CK > 5 × ULN at screening,
- •History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
- •History or presence of clinically significant hepatic disease,
- •History of epileptic disorder or any seizure history unrelated to tumour,
- •History of MDS/AML or with features suggestive of MDS/AML,
- •Predisposition to bleeding
- •History of persisting (> 2 weeks) severe cytopenia
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
- •History of another primary malignancy
- •Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
- •Spinal cord compression or brain metastases for at least 4 weeks
研究者
研究点 (2)
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