A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
研究概览
简要总结
This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan).
- •Have a solid tumor that has progressed on standard treatment:
- •For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic
- •For patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or BRCA 1/2 mutated breast cancer, or other solid tumor with BRCA 1/2 or related gene mutation
- •Have to have evaluable disease (i.e. disease can be followed on scans.)
- •Be willing and able to fast for at least 14 hours
排除标准
- •Active second malignancy
- •Prior treatment with any PARP inhibitor
- •Symptomatic and/or untreated CNS metastases
- •Women who are breastfeeding or pregnant
- •Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
- •Requires regular blood transfusions
研究组 & 干预措施
Oral Rucaparib monotherapy
Part I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.)
干预措施: Rucaparib (Drug)
结局指标
主要结局
Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
时间窗: From enrollment to completion of Part I (up to 12 months)
Number of participants with serious AEs as a measure of safety and tolerability
时间窗: From enrollment to completion of Part I (up to 12 months)
Number of participants with worsening laboratory values as a measure of safety and tolerability
时间窗: From enrollment to completion of Part I (up to 12 months)
次要结局
- Dose-limiting toxicities (DLTs) during Cycle 1 of treatment(From enrollment to completion of Part I (up to 12 months))
- Peak Plasma Concentration [Cmax](From enrollment to completion of Part I (up to 12 months))
- Total Plasma Clearance [CI/F](From enrollment to completion of Part I (up to 12 months))
- Response to treatment according to RECIST Version 1.1(From enrollment to primary completion of study (up to 3 years))
- Area under the plasma concentration versus time curve [AUC](From enrollment to completion of Part I (up to 12 months))