A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.
详细描述
MTD - maximum tolerated dose
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
- 20 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
- •Subjects who have overall good overall general condition.
- •Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day
- •Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
- •Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits
排除标准
- •Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
- •Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
- •Subjects with symptomatic uncontrolled brain metastases.
- •Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
- •Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.
研究组 & 干预措施
olaparib tablet monotherapy
olaparib tablet
干预措施: olaparib (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the start dose to 30 days after the last dose of study drug
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.
次要结局
- Number of Participants With Dose Limiting Toxicities(From the start dose to 28 days after the first dose of study drug)
- AUC at Steady State Following Multiple Dosing(Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose)
- AUC Following Single Dosing(Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose)
- Cmax Following Multiple Dosing(Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose)
- Cmax Following Single Dosing(Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose)
- Tmax Following Single Dosing(Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose)
- Tmax Following Multiple Dosing(Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose)