IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
研究概览
简要总结
This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.
详细描述
The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Histopathologically confirmed diagnosis of a metastatic NET.
- •Documented history of carcinoid syndrome.
- •Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care.
- •ECOG performance status 0-1 and/or Karnofsky >60%.
- •Greater than or equal to 3 month life expectancy.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection.
- •History of short bowel syndrome.
- •Clinically important baseline elevation in liver function tests.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Malignant ascites requiring paracenteses.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Bowel obstruction, partial, or total.
- •Pregnancy
- •Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
研究组 & 干预措施
Standard of Care telotristat ethyl (Xermelo) Treatment
Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.
干预措施: telotristat ethyl (Drug)
结局指标
主要结局
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
时间窗: From baseline to 13 weeks after treatment
次要结局
- Mean change in daily activity levels (steps) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
- Mean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.(From baseline to 13 weeks post-treatment.)
- Mean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
- Mean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
- Mean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
- Mean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
- Mean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.(From baseline to 3 years post treatment)
- Mean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.(From baseline to 3 years post treatment)
- Mean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.(From baseline to 13 weeks post-treatment)
研究者
Andrew Hendifar, MD
Assistant Professor of Medicine
Cedars-Sinai Medical Center