A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
250 mg Telotristat Etiprate
One telotristat etiprate (250 mg) tablet administered three times daily.
干预措施: Telotristat etiprate (Drug)
500 mg Telotristat Etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily.
干预措施: Telotristat etiprate (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: 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.
次要结局
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit(Baseline, Weeks 24, 48, 72 and 84)
- Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit(Baseline, Weeks 24, 48, 72 and 84)
- Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question(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(Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84)