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A Study of LY3023414 in Japanese Participants With Advanced Cancer

2018年7月20日 更新者:Eli Lilly and Company

A Phase 1 Study of LY3023414 in Japanese Patients With Advanced Malignancies

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.

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)

12

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

      • Chiba、日本、277 8577
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
      • Tokyo、日本、104-0045,
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria

  • Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate.
  • Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Have adequate organ and coagulation function.
  • Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
  • Are able to swallow capsules.
  • Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
  • Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
  • A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.

Exclusion Criteria

  • Have serious pre-existing medical conditions.
  • Have symptomatic central nervous system malignancy or metastasis.
  • Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
  • Have a known active fungal, bacterial, and/or known viral infection.
  • Intolerance to any previous treatment with any phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitor. Treatment with any PI3K/AKT/mTOR inhibitor must have discontinued for at least 21 days or 5 half-lives prior to first study drug administration, whichever is shorter, and participants must have recovered from the acute effects of therapy.
  • Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.
  • Participants with active alcohol abuse, as determined by the investigator.
  • Have a history of heart failure according to New York Heart Association Class ≥3.
  • Have corrected QT (QTc) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
  • Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
  • Have any evidence of clinically active interstitial lung disease (ILD).

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:LY3023414
LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
LY3023414 administered orally.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
大体时间:Cycle 1 (21 days)
Cycle 1 (21 days)

次要结果测量

结果测量
大体时间
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414
大体时间:Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414
大体时间:Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])
大体时间:Baseline through study completion (estimated as up to five months)
Baseline through study completion (estimated as up to five 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。

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

2015年9月1日

初级完成 (实际的)

2017年2月9日

研究完成 (实际的)

2017年2月9日

研究注册日期

首次提交

2015年8月28日

首先提交符合 QC 标准的

2015年8月28日

首次发布 (估计)

2015年9月1日

研究记录更新

最后更新发布 (实际的)

2018年7月24日

上次提交的符合 QC 标准的更新

2018年7月20日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 15838
  • I6A-JE-CBBH (其他标识符:Eli Lilly and Company)

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.

LY3023414的临床试验

3
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