Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).
详细描述
Neuroendocrine tumors (NETs) are a very heterogeneous group of tumors that develop predominantly in the gastrointestinal and pulmonary systems. Clinical detection and diagnosis are more reliable at late stages when metastatic spread has occurred. Patients with advanced disease may suffer from complications of uncontrolled hormone secretion and usually succumb due to tumor progression.
This trial tests the hypothesis that inhibition of serotonin production with Telotristat will lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor activity of Lutetium 177 Dotatate. The proposed combination may result in improved treatment efficacy as reflected by improved 20-month progression-free survival (PFS) as compared to historical control.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment
- •Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria
- •Failure of at least one prior systemic cancer treatment for this diagnosis
- •Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •normal organ and marrow function
排除标准
- •Prior exposure to Lutetium Lu 177 Dotatate
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate.
- •Presence of unstable angina or myocardial infarction
- •New York Heart Association (NYHA) Class III or IV heart failure
- •uncontrolled angina
- •history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities
- •Pregnant or lactating women
- •Women of childbearing potential or male patients of reproductive potential
- •Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study
研究组 & 干预措施
Arm 1: Low-Dose Telotristat
Participants in this group will receive 750mg Telotristat per day.
干预措施: Telotristat (Low-Dose) (Drug)
Arm 2: High-Dose Telotristat
Participants in this group will receive 1500mg Telotristat per day.
干预措施: Telotristat (High-Dose) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 20 months
Progression-free survival at 20 months.
次要结局
- Median Progression-Free Survival (PFS)(36 month)
- Quality of Life (QLQ-C30)(20 month)
- Overall Response Rate (ORR)(6 and 12 months)
- Quality of Life (QLQ-GI.NET21)(20 month)
- Urinary 5-HIAA(Baseline and 12 months)
研究者
Lowell Anthony, MD
Professor
University of Kentucky