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Serotonin Inhibitor

Telotristat Ethyl for Neuroendocrine Tumors

Phase 3

Waitlist Available

Led By Saamir A Hassan

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histopathologically-confirmed, metastatic neuroendocrine tumor and/or locally/regionally advanced neuroendocrine tumor

Adequate methods of contraception, defined as having a failure rate of < 1% per year, for patients or their partner include the following: condom with spermicidal gel, diaphragm with spermicidal gel, intrauterine device, surgical sterilization, vasectomy, oral contraceptive pill, depo-progesterone injections, progesterone implant (ie, Implanon), patch (Ortho Evra), NuvaRing, and abstinence. If a patient is not sexually active but becomes active, he or his partner should use medically accepted forms of contraception

Must not have

Patients receiving everolimus due to poor response to SSA

Arrhythmia causing hemodynamic compromise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

Who is the study for?

Adults (18+) with metastatic neuroendocrine tumors and carcinoid syndrome, currently on stable somatostatin analog therapy. They must be able to consent, use effective contraception if of childbearing potential, and have an ECOG performance status of 0-2. Exclusions include prior telotristat ethyl use within 3 months, significant cardiac issues, severe liver or kidney impairment, pregnancy/lactation, short life expectancy (<6 months), recent other cancer treatments or investigational drugs.

What is being tested?

This phase III trial is testing whether adding telotristat ethyl to standard somatostatin analog therapy is more effective than the standard therapy alone in controlling symptoms and heart disease related to carcinoid syndrome in patients with metastatic neuroendocrine tumors.

What are the potential side effects?

Potential side effects may include gastrointestinal issues such as constipation or diarrhea, fatigue, headache, depression or mood changes. There's also a risk for liver enzyme elevations which could indicate liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a confirmed neuroendocrine tumor that has spread or is advanced locally.

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I am using or willing to use effective birth control or practice abstinence.

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I have a documented history of carcinoid syndrome.

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I am 18 years old or older.

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I am taking Lanreotide 120 mg every 4 weeks.

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I can perform daily activities with little to no assistance.

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I am taking Octreotide LAR 30 mg every 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking everolimus because my previous treatment didn't work well.

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I have a heart rhythm problem that affects my blood circulation.

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I have severe heart valve problems causing symptoms.

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I am able to communicate and cooperate with my doctor.

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My kidney function is low, with an eGFR below 30 ml/min.

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I have had chest pain with signs of heart strain on an ECG.

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I have severe heart failure symptoms.

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I haven't taken any experimental drugs for carcinoid syndrome or heart disease in the last 30 days.

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I have not taken XERMELO in the last 3 months.

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I have unstable chest pain.

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I have had ongoing constipation or a blockage in my bowels in the last 6 months.

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I have a history of conditions causing diarrhea not related to carcinoid syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (telotristat ethyl, SSA)Experimental Treatment2 Interventions

Patients receive telotristat ethyl PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (placebo, SSA)Active Control2 Interventions

Patients receive placebo PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telotristat Ethyl

2017

Completed Phase 1

~20

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

TerSera Therapeutics LLCIndustry Sponsor

9 Previous Clinical Trials

1,263 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,622 Total Patients Enrolled

Saamir A HassanPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Telotristat Ethyl (Serotonin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04810091 — Phase 3

Neuroendocrine Neoplasm Research Study Groups: Arm B (placebo, SSA), Arm A (telotristat ethyl, SSA)

Neuroendocrine Neoplasm Clinical Trial 2023: Telotristat Ethyl Highlights & Side Effects. Trial Name: NCT04810091 — Phase 3

Telotristat Ethyl (Serotonin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04810091 — Phase 3

~18 spots leftby Sep 2025

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