Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tu… (NCT04672876) | Clinical Trial Compass
WithdrawnPhase 2
Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors
Stopped: Trial funding no longer available.
0Started 2022-01
Plain-language summary
This is a study to determine if a certain drug, called telotristat ethyl (Xermelo®), can help reduce the chance of blood pressure and heart rate variations (known as carcinoid crisis) in individuals who have neuroendocrine tumors (also called carcinoid tumors). These complications can be life-threatening for patients who already have to experience challenging surgeries to remove their tumors. To determine if telotristat ethyl (Xermelo®) will help reduce these complications during surgery, researchers will give the drug to study participants before surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a grade 1 or grade 2 small bowel, neuroendocrine tumor (NET) that has been medically confirmed by a physician.
* Patients who plan to have abdominal (stomach) surgery due to cancer that has spread to their liver. Patients must voluntarily choose to have surgery.
* 18 years old or older.
* Patients with small bowel neuroendocrine tumors who are asymptomatic (not showing symptoms) but have elevated serotonin or 5-HIAA (5-hydroxyindoleacetic acid) levels before surgery.
* Patients who are symptomatic (showing carcinoid symptoms) and have elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery.
Exclusion Criteria:
* Patients belonging to vulnerable populations such as children and prisoners.
* Patients with grade 3 neuroendocrine tumors or neuroendocrine tumors that are hard to identify.
* Patients with untreated carcinoid heart disease.
* Patients who are receiving any other drugs or treatment as part of a research study.
* Patients with a "currently active" second tumor other than non-melanoma skin cancers. Patients are not considered to have a "currently active" tumor if they have completed therapy and are free of disease for 3 or more years.
* Patients with known brain cancers.
* Patients who have a history of allergic reactions to medications that have similar chemical or biologic ingredients as those found in telotristat ethyl.
* Uncontrolled illness that occurs while having cancer such as, but not limited…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Observed Carcinoid Crises During Surgery