JPRN-jRCT2080222063未知1 期
A Phase 1, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
适应症
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
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 ot applicable（—）
- 性别
- All
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 15.
- •- 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.
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