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NCT04810091 · ClinicalTrials.gov registry record · Phase 3
Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor
A Phase 3 study of Metastatic Neuroendocrine Neoplasm and Locally Advanced Neuroendocrine Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT04810091: Active Phase 3 study of Metastatic Neuroendocrine Neoplasm and Locally Advanced Neuroendocrine Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04810091 is a Phase 3 study of Metastatic Neuroendocrine Neoplasm and Locally Advanced Neuroendocrine Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 79 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04810091, a Phase 3 study of Metastatic Neuroendocrine Neoplasm and Locally Advanced Neuroendocrine Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin analog therapy may help to control carcinoid syndrome and carcinoid heart disease.
Primary Outcome
Percent change in N-terminal pro B-type natriuretic peptide (NT-proBNP) from baseline to 6 months defined as (NTproBNP at 6 month - NTproBNP at baseline)/(NTproBNP at baseline)\*100
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Telotristat Ethyl
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2026-08-03 |
| Phase | Phase 3 |
What the registry record for NCT04810091 still lists
NCT04810091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Metastatic Neuroendocrine Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT04810091 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04810091 about?
NCT04810091 is a clinical study titled "Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor". This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin ...
What is the current status of trial NCT04810091?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2021-05-18. Estimated completion is 2026-08-03.
What conditions does trial NCT04810091 study?
This clinical trial studies the following conditions: Metastatic Neuroendocrine Neoplasm, Locally Advanced Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT04810091?
The interventions under investigation include: Questionnaire Administration (OTHER), Placebo Administration (DRUG), Telotristat Ethyl (DRUG).
Who is sponsoring clinical trial NCT04810091?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04810091 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04810091's enrollment target sits among peer trials
79 1768th of 2000 higher than 232 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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