JPRN-UMIN000025521已完成1 期
Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors - Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
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
- 3years-old 至 18years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Involvement in the planning and/or conduct of the study. (2)Previous enrolment and administration of olaprib in the past study. (3)Any previous treatment with PARP inhibitor, including olaparib. (4)Other malignancy in the past. (5)Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 21 days prior to study treatment. (6)Patients with symptomatic uncontrolled brain metastases. (7)Patients with gastrointestinal disorders likely to interfere with absorption of the study medication. (8)BSA <0.4 m2 at enrollment. (9)Administration of other study drugs within 21 days prior enrollment. (10)Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 14 days. (11)Concomitant use of known CYP3A inducers. The required washout period prior to starting olaparib is 21 days. See details at restriction. (12)Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous therapy. (13)Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. (14)Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. (15)Breast feeding women. (16)Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) (17)Patients with known active hepatitis (i.e. Hepatitis B or C) (18)Patients with a known hypersensitivity to olaparib or any of the excipients of the product. (19)Patients who have undergone auto hematopoietic stem cell transplantation (HSCT) within 112 days (4 months) prior to enrollment (20)Patients who have previous allogenic hematopoietic stem cell transplantation (HSCT) (21)Are otherwise inappropriate for this study in the investigator's or subinvestigator's opinion.
研究者
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