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Telotristat Ethyl for Neuroendocrine Tumors
Study Summary
This trial is comparing telotristat ethyl to the current standard of care, somatostatin analog therapy, in treating patients with neuroendocrine tumors that have spread to other parts of the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My heart condition won't risk my safety or affect the study's results.I am taking everolimus because my previous treatment didn't work well.Your doctor thinks you have less than 6 months to live.I have a heart rhythm problem that affects my blood circulation.I do not have serious heart rhythm problems that could affect my safety or the study results.I have severe heart valve problems causing symptoms.I don't have any health issues that could risk my safety in the study.I agree to use birth control during and for 30 days after the study.I have been treated for cancer other than neuroendocrine tumor, but it's considered cured.I am taking the highest dose of SSA therapy that I can tolerate.You have had issues with digesting galactose or lactose in the past.I am able to communicate and cooperate with my doctor.I haven't had cancer treatments like chemotherapy or radiation in the last 4 weeks.My kidney function is low, with an eGFR below 30 ml/min.I am capable of becoming pregnant because I have not been sterilized and am not postmenopausal.My cancer is a confirmed neuroendocrine tumor that has spread or is advanced locally.I am using or willing to use effective birth control or practice abstinence.I have had chest pain with signs of heart strain on an ECG.I have severe heart failure symptoms.I haven't taken any experimental drugs for carcinoid syndrome or heart disease in the last 30 days.I have not taken XERMELO in the last 3 months.I have unstable chest pain.I have a documented history of carcinoid syndrome.I am 18 years old or older.I have had ongoing constipation or a blockage in my bowels in the last 6 months.You have any other significant abnormality in your lab tests that could potentially harm you or affect the study results, according to the primary investigator's decision.I am on a stable dose of long-acting or depot hormone therapy.I am taking Lanreotide 120 mg every 4 weeks.I have been on a stable dose of somatostatin analog therapy for at least 2 months.I can perform daily activities with little to no assistance.I have a history of conditions causing diarrhea not related to carcinoid syndrome.You have had problems with drugs or alcohol in the past 2 years, as defined by the DSM-V guidelines.I am taking Octreotide LAR 30 mg every 4 weeks.
- Group 1: Arm B (placebo, SSA)
- Group 2: Arm A (telotristat ethyl, SSA)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Telotristat Ethyl been cleared by the FDA?
"Telotristat Ethyl has been evaluated for safety and our team has given it a score of 3."
Are there any positions available for volunteers in this research project?
"Yes, the clinicaltrials.gov website currently lists this study as recruiting patients. This trial was originally posted on May 18th, 2021 and was last updated on June 15th, 2022. The researchers conducting this trial need to enroll 60 patients from 1 site."
What is the historical data for Telotristat Ethyl's efficacy?
"As of now, there are 4 ongoing clinical trials studying Telotristat Ethyl, 1 of which is in Phase 3. Most of the research is conducted in Houston, Texas, but there are a total of 6 locations running trials."
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