此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)

2019年8月22日 更新者：Lexicon Pharmaceuticals

A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

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)

124

阶段

  • 第三阶段

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

  • 以色列
      • Jerusalem、以色列、91120
        • Lexicon Investigational Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N4N2
        • Lexicon Investgational Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B0J1N0
        • Lexicon Investigational Site
  • 德国
      • Bad Berka、德国、99437
        • Lexicon Investigational Site
      • Berlin、德国、13353
        • Lexicon Investigational Site
      • Essen、德国、45147
        • Lexicon Investigational Site
      • Hamburg、德国、20246
        • Lexicon Investigational Site
      • Marburg、德国、35043
        • Lexicon Investigational Site
  • 意大利
      • Milano、意大利、20089
        • Lexicon Investigational Site
      • Milano、意大利、20141
        • Lexicon Investigational Site
      • Pisa、意大利、56124
        • Lexicon Investigational Site
      • Torino、意大利、10043
        • Lexicon Investigational Site
  • 比利时
      • Edegem、比利时、B-2650
        • Lexicon Investigational Site
      • Ghent、比利时、9000
        • Lexicon Investigational Site
      • Yvoir、比利时、5530
        • Lexicon Investigational Site
  • 法国
      • Lille、法国、59037
        • Lexicon Investigational Site
      • Lyon、法国、69437
        • Lexicon Investigational Site
      • Villejuif、法国、94805
        • Lexicon Investigational Site
  • 澳大利亚
    • New South Wales
      • St. Leonards、New South Wales、澳大利亚、2065
        • Lexicon Investigational Site
    • Queensland
      • Herston、Queensland、澳大利亚、4029
        • Lexicon Investigational Site
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3002
        • Lexicon Investigational Site
  • 瑞典
      • Lund、瑞典、22185
        • Lexicon Investigational Site
      • Uppsala、瑞典、75185
        • Lexicon Investigational Site
  • 美国
    • Alabama
      • Mobile、Alabama、美国、36604
        • Lexicon Investigational Site
    • California
      • Stanford、California、美国、94305
        • Lexicon Investigational Site
    • Iowa
      • Iowa City、Iowa、美国、52242
        • Lexicon Investigational Site
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • Lexicon Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Lexicon Investigational Site
    • New York
      • New York、New York、美国、10029
        • Lexicon Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Lexicon Investigational Site
  • 英国
      • Coventry、英国、CV22DX
        • Lexicon Investigational Site
      • Glasgow、英国、G120YN
        • Lexicon Investigational Site
      • London、英国、NW32QG
        • Lexicon Investigational Site
      • London、英国、SE59RS
        • Lexicon Investigational Site
      • London、英国、W120HS
        • Lexicon Investigational Site
      • Manchester、英国、M204BX
        • Lexicon Investigational Site
      • Newcastle-Upon-Tyne、英国、NE14LP
        • Lexicon Investigational Site
  • 荷兰
      • Amsterdam、荷兰、1105AZ
        • Lexicon Investigational Site
      • Noord Holland、荷兰、1066CX
        • Lexicon Investigational Site
      • Noord-Brahant、荷兰、5631BM
        • Lexicon Investigational Site
  • 西班牙
      • Barcelona、西班牙、08035
        • Lexicon Investigational Site
      • Madrid、西班牙、28034
        • Lexicon Investigational Site
      • Seville、西班牙、41013
        • Lexicon Investigational 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

18年 及以上 (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:

  • Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] study
  • Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
  • Positive pregnancy test
  • Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination

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：非随机化
  • 介入模型：并行分配
  • 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：250 mg Telotristat Etiprate
One telotristat etiprate (250 mg) tablet administered three times daily.
药品：Telotristat etiprate
Telotristat etiprate tablet (250 mg)
其他名称：
  • LX1606
实验性的：500 mg Telotristat Etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily.
药品：Telotristat etiprate
Telotristat etiprate tablet (250 mg)
其他名称：
  • LX1606

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 Participants With Treatment-Emergent Adverse Events (TEAEs)
大体时间：First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
大体时间：Baseline, Weeks 24, 48, 72 and 84
QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
Baseline, Weeks 24, 48, 72 and 84
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
大体时间：Baseline, Weeks 24, 48, 72 and 84
GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
Baseline, Weeks 24, 48, 72 and 84
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
大体时间：Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Participants were asked to respond to the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort? The percentage of participants reporting adequate relief (answered Yes) were reported.
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
大体时间：Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement.
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

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

Lexicon Pharmaceuticals

调查人员

  • 研究主任：Pablo LaPuerta, MD、Lexicon Pharmaceuticals, Inc.

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)

2014年1月14日

初级完成 (实际的)

2018年9月12日

研究完成 (实际的)

2018年9月12日

研究注册日期

首次提交

2013年12月31日

首先提交符合 QC 标准的

2013年12月31日

首次发布 (估计)

2014年1月1日

研究记录更新

最后更新发布 (实际的)

2019年9月17日

上次提交的符合 QC 标准的更新

2019年8月22日

最后验证

2019年8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

  • LX1606.1-302-CS
  • LX1606.302 (其他标识符：Lexicon Pharmaceuticals, Inc.)
  • 2013-002596-18 (EudraCT编号)

药物和器械信息、研究文件

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.

订阅