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Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

2019年6月21日 更新者：AstraZeneca

A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

11

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。

学习地点

  • 日本
      • Kashiwa、日本、277-8577
        • Research Site
      • Matsuyama-shi、日本、791-0280
        • Research Site

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

20年 至 120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

Key Inclusion Criteria:

  • Male and female patients must be at least 20 years of age.
  • Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
  • Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
  • Adequate organ and marrow function
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

Key Exclusion Criteria:

  • Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
  • Patients must have completed any previous cancer-related treatments before enrolment.
  • Has active or prior autoimmune disease within the past 2 years
  • Has active or prior inflammatory bowel disease or primary immunodeficiency
  • Undergone an organ transplant that requires use of immunosuppressive treatment
  • Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
  • Prior exposure to AZD9150 or any other anti PD (L)1 antibody.

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：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：C1:AZD9150, C2:AZD9150+Durvalumab
After confirmed safety with Cohort 1, Cohort 2 will open
药品：AZD9150, Durvalumab
After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT

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
Safety and tolerability in terms of adverse events
大体时间：From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.

次要结果测量

结果测量
措施说明
大体时间
Maximum plasma concentration (Cmax)
大体时间：From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
Overall response rate
大体时间：Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Defined as the proportion of subjects who achieve a response.
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Duration of Response
大体时间：Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Area under the plasma concentration-time curve (AUC)
大体时间：From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
PK parameters will be derived using standard non-compartmental methods.
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.

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

AstraZeneca

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。

一般刊物

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)

2018年1月30日

初级完成 (实际的)

2019年4月12日

研究完成 (实际的)

2019年4月12日

研究注册日期

首次提交

2017年11月10日

首先提交符合 QC 标准的

2018年1月3日

首次发布 (实际的)

2018年1月9日

研究记录更新

最后更新发布 (实际的)

2019年6月24日

上次提交的符合 QC 标准的更新

2019年6月21日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • D5660C00017

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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