NCT04672876

Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors

Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

What is carcinoid crisis and why study telotristat ethyl to help reduce it? Surgery and anesthesia can cause sudden, dangerous, difficult-to-control changes in blood pressure and heart rate (a "carcinoid crisis") in patients with carcinoid tumors. Patients who have crises for a duration of 10 minutes or longer have a 12-fold increased risk of major complications during surgery. Historically, it has been believed that crises were due to a massive release of carcinoid hormones from tumors in the blood; therefore, this study will investigate if telotristat ethyl (Xermelo®) can help block this hormone release and reduce the rate of dangerous complications that patients with carcinoid tumors may experience during surgery to remove their tumors. What will this study involve and how long will it last for participants? The study involves blood tests before, during and after surgery, and taking telotristat ethyl (Xermelo®) tablets orally for two weeks before surgery and on the day of surgery (no later than 2 hours prior to surgery).

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Telotristat Ethyl Oral Tablet	XERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for Carcinoid Syndrome diarrhea in adults who are not adequately controlled by SSA therapy. The drug is currently FDA-approved for this use but this study has received special approval from the FDA (under an Investigational Drug Application) to study telotristat ethyl in individuals with carcinoid tumors who plan to undergo surgery.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-12-17
• Last updated: 2021-12-17

Regulatory

• FDA-regulated drug study