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Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

2018年11月30日 更新者：AstraZeneca

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

95

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

  • 德国
      • Frankfurt、德国、60488
        • Research Site
      • Freiburg、德国、79106
        • Research Site
      • Köln、德国、50924
        • Research Site
  • 意大利
      • Napoli、意大利、80131
        • Research Site
      • Rozzano、意大利、20089
        • Research Site
  • 法国
      • Pierre Benite、法国、69495
        • Research Site
      • Villejuif、法国、94805
        • Research Site
  • 美国
    • California
      • Stanford、California、美国、94305
        • Research Site
    • Colorado
      • Aurora、Colorado、美国、80045
        • Research Site
    • Connecticut
      • New Haven、Connecticut、美国、06520
        • Research Site
    • Michigan
      • Detroit、Michigan、美国、48201
        • Research Site
    • New York
      • New York、New York、美国、10021
        • Research Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Research Site
    • Texas
      • Houston、Texas、美国、77030
        • Research Site
  • 英国
      • Birmingham、英国、B9 5SS
        • Research Site
      • Edinburgh、英国、EH4 2XU
        • Research Site
      • Glasgow、英国、G12 0YN
        • Research Site
      • London、英国、W1G 6AD
        • Research Site
      • London、英国、W12 0NN
        • Research Site
      • Manchester、英国、M20 4BX
        • Research Site
      • Newcastle upon Tyne、英国、NE7 7DN
        • Research Site
      • Wolverhampton、英国、WV10 0QP
        • Research Site
  • 荷兰
      • Amsterdam、荷兰、1066 CX
        • Research Site
      • Rotterdam、荷兰、3015 CE
        • Research Site
  • 西班牙
      • Badajoz、西班牙、06008
        • Research Site
      • Majadahonda、西班牙、28222
        • Research Site
      • Valencia、西班牙、46010
        • Research Site
      • Valencia、西班牙、46026
        • 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

25年 至 149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:

  • Minimum life expectancy of 12 weeks
  • The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
  • In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
  • Expansion, 5 groups of advanced cancer
  • Solid tumours,FGFR1 and/or FGFR2 gene amplified
  • Squamous NSCLC, FGFR1 gene low & high amplified
  • Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
  • Aged at least 25 years

Exclusion Criteria:

  • Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
  • An inability to be able to take the study medication
  • A bad reaction to AZD4547 or any drugs similar to it in structure or class.

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：Part A
Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
药品：AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose
实验性的：Part B
Dose expansion phase, at the RD defined in Part A
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
药品：AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose
实验性的：Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
药品：AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
药品：AZD4547
Single dose is followed by washout 5-10 days before multiple dose

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
Number of Patients Who Experienced at Least 1 AE
大体时间：AEs are monitored from screenng through to 30 day follow up period
To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.
AEs are monitored from screenng through to 30 day follow up period
Number of Participants Who Experienced at Least 1 Causally Related AE.
大体时间：AEs are continually assessed from screening up to 30 day FU period
To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.
AEs are continually assessed from screening up to 30 day FU period
Number of Participants With at Least 1 AE of CTCAE >=G3
大体时间：Ongoing up to discontinuation up to 30 day FU.
To investigate the safety and tolerability of AZD4547
Ongoing up to discontinuation up to 30 day FU.
Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3
大体时间：Ongoing up to discontinuation up to 30 day FU.
To investigate the safety and tolerability of AZD4547
Ongoing up to discontinuation up to 30 day FU.
Number of Participants Who Experienced at Least One SAE
大体时间：Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.
Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
Number of Participants With at Least 1 Causally Related SAE
大体时间：SAEs are continually monitored from screening to end of 30 FU period
To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547
SAEs are continually monitored from screening to end of 30 FU period

次要结果测量

结果测量
措施说明
大体时间
AUC(0-infinity)
大体时间：PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)
大体时间：Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is >=30% reduction in sum of longest diameter of target lesions
Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
Cmax (ng/mL)
大体时间：PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Css,Max (ng/mL)
大体时间：PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
AUC,ss(0-infinity)
大体时间：PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.

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

调查人员

  • 首席研究员：Fabrice André, Dr、Institut de Cancérologie Gustave Roussy
  • 研究主任：Donal Landers, Dr、AstraZeneca

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)

2009年10月21日

初级完成 (实际的)

2014年2月12日

研究完成 (实际的)

2015年3月5日

研究注册日期

首次提交

2009年9月16日

首先提交符合 QC 标准的

2009年9月16日

首次发布 (估计)

2009年9月17日

研究记录更新

最后更新发布 (实际的)

2019年3月15日

上次提交的符合 QC 标准的更新

2018年11月30日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D2610C00001

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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