D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
2017年8月25日 更新者：AstraZeneca
A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients With Advanced Solid Tumours.
This is a 2 part study for patients with solid tumours.
The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none).
In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum).
Treatment can continue for as long as the patient is benefitting.
Throughout the study patients will be monitored for any side effects.
研究概览
研究类型
介入性
注册 (实际的)
32
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 130年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients aged ≥18 years, male and female
- Able to eat a high-fat breakfast within a 30-minute period, as provided by the study site
- Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
- ECOG performance status ≤2
- Normal organ and bone marrow function measured within 28 days prior to administration of IP as defined in protocol
Exclusion Criteria:
- Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 2 weeks prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
- Toxicities (≥CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia
- Patients unable to fast for up to 14 hours or who have type I or type II diabetes
- Patients who have gastric, gastro-oesophageal or oesophageal cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Fasted
Olaparib capsules following no breakfast
|
400mg olaparib capsule formulation taken 30 minutes after allocated meal.
5-14 days between arms.
Allocated breakfast prior to dosing with 400mg olaparib capsules
|
|
其他：Standard meal
Olaparib capsules after standard breakfast
|
400mg olaparib capsule formulation taken 30 minutes after allocated meal.
5-14 days between arms.
Allocated breakfast prior to dosing with 400mg olaparib capsules
|
|
其他：High Fat
Olaparib capsules after high fat breakfast
|
400mg olaparib capsule formulation taken 30 minutes after allocated meal.
5-14 days between arms.
Allocated breakfast prior to dosing with 400mg olaparib capsules
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetics of Olaparib (Cmax and tmax)
大体时间：Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
|
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax)
|
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
|
|
Pharmacokinetics of Olaparib (AUC0-t)
大体时间：Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
|
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)
|
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
|
|
Pharmacokinetics of Olaparib (AUC)
大体时间：Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
|
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
|
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
|
|
Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½)
大体时间：Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
|
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)
|
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety monitoring of Olaparib
大体时间：AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue
|
Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis).
Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.
|
AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Anitra Fielding、AstraZeneca Senior Research Physician
- 首席研究员：Christian Rolfo、UZ Antwerpen
- 学习椅：Wendy Bannister、AstraZeneca Study Statistician
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年7月4日
初级完成 (实际的)
2013年10月18日
研究完成 (实际的)
2017年6月6日
研究注册日期
首次提交
2013年5月8日
首先提交符合 QC 标准的
2013年5月8日
首次发布 (估计)
2013年5月10日
研究记录更新
最后更新发布 (实际的)
2017年8月28日
上次提交的符合 QC 标准的更新
2017年8月25日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- D081AC00001
- 2013-001255-13 (EudraCT编号)
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