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Enzyme Inhibitor

Telotristat Etiprate for Carcinoid Syndrome

Phase 2

Recruiting

Led By Anthony Shields

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial is testing how well telotristat etiprate works in treating neuroendocrine neoplasm. Telotristat etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying the changes within the tumor cells may help doctors better understand how tumors respond to treatment with telotristat etiprate.

Eligible Conditions

Neuroendocrine Tumors
Carcinoid Syndrome
Neuroendocrine Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients who achieved maximum standardized uptake value (SUVmax) reduction of 20% or more

Secondary outcome measures

Change in mean standardized uptake value (SUVmean)

Neuroendocrine tumors visibility

Tumoral calcinosis

+1 more

Side effects data

From 2013 Phase 2 trial • 59 Patients • NCT01456052

13%

Colitis ulcerative

Abdominal pain

Diarrhoea

Dyspepsia

Sinusitis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Low Dose Telotristat Etiprate

High Dose Telotristat Etiprate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AMT-PET, telotristat etiprate)Experimental Treatment4 Interventions

Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate PO TID for 9-14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Telotristat Etiprate

2012

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,280 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,661 Total Patients Enrolled

Anthony ShieldsPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

2 Previous Clinical Trials

8 Total Patients Enrolled

Media Library

Telotristat Etiprate (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03453489 — Phase 2

Carcinoid Syndrome Research Study Groups: Treatment (AMT-PET, telotristat etiprate)

Carcinoid Syndrome Clinical Trial 2023: Telotristat Etiprate Highlights & Side Effects. Trial Name: NCT03453489 — Phase 2

Telotristat Etiprate (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03453489 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant size of this experimental endeavor?

"Affirmative. Based on the information available through clinicaltrials.gov, this study is recruiting patients at present time. It was initially posted in June 2018 and most recently updated by March 2022--seeking a total of 6 participants from one site."

Answered by AI

What ailments has Telotristat Etiprate been most successful in alleviating?

"Telotristat Etiprate is the usual first-line treatment for amino acid supplementation therapy. It has also shown to help with treating depression, kidney failure, and dialysis therapy."

Answered by AI

What adverse effects have been reported with Telotristat Etiprate?

"Based on the evidence currently available, Telotristat Etiprate scored a 2 for safety. This is because while there are initial data regarding its safety profile, no information has been gathered yet to confirm efficacy."

Answered by AI

Are there still openings for participation in this trial?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was launched on June 20th 2018, is presently open to enrollees. 6 volunteers are required at a single recruitment site for the duration of the study."

Answered by AI

Could you please outline any other experiments conducted regarding Telotristat Etiprate?

"Presently, 12 active trials are researching the effects of Telotristat Etiprate with 6 in their final phase. Although Houston is a hub for this research, 1492 sites across the world have chosen to participate in these studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm

Anthony F. Shields, MD PhD 2018. "AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03453489.

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